Trial Outcomes & Findings for TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer (NCT NCT06001762)

Last Updated: 2026-07-02

Results Overview

The composite endpoint is the number and proportion of participants with abemaciclib discontinuation for any reason and/or abemaciclib dose reductions and/or the inability of study participants to reach the target dose of abemaciclib (full dose 150 mg BID) at 3 months (12 weeks).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

3 months (12 weeks)

Results posted on

2026-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Abemaciclib The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib n=90 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards. Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Age, Continuous	58 years n=20 Participants
Sex: Female, Male Female	90 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=20 Participants
Race/Ethnicity, Customized Race · White	72 Participants n=20 Participants
Race/Ethnicity, Customized Race · Asian	6 Participants n=20 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=20 Participants
Race/Ethnicity, Customized Race · Other	8 Participants n=20 Participants
Clinical Stage Stage II	46 Participants n=20 Participants
Clinical Stage Stage III	44 Participants n=20 Participants
Endocrine therapy type at therapy initiation Aromatase Inhibitor	74 Participants n=20 Participants
Endocrine therapy type at therapy initiation Aromatase Inhibitor and Ovarian Suppression	16 Participants n=20 Participants

PRIMARY outcome

Timeframe: 3 months (12 weeks)

Population: Subjects who received at least one dose of abemaciclib and did not progress within 12 weeks of starting treatment. One (1) subject had a progression event within 12 weeks of starting treatment. Therefore, this subject is excluded from the primary endpoint analysis.

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks) Abemaciclib discontinuation, dose reduction, and/or taking less than target dose at 12 weeks	26 Participants
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks) Achieved abemaciclib target dose at 12 weeks	63 Participants

SECONDARY outcome

Timeframe: 3 months (12 weeks)

Number of participants unable to reach the full dose (150 mg BID) of abemaciclib at 3 months (12 weeks)

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants Unable to Reach Full Dose of Abemaciclib at 3 Months (12 Weeks) Participant unable to reach abemaciclib full dose at 12 weeks	8 Participants
Number of Participants Unable to Reach Full Dose of Abemaciclib at 3 Months (12 Weeks) Abemaciclib discontinued, dose reduced, or full dose reached by 12 weeks	81 Participants

SECONDARY outcome

Timeframe: 3 months (12 weeks)

Number of participants who discontinued abemaciclib treatment for any reason 3 months (12 weeks)

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants Who Discontinued Abemaciclib Treatment for Any Reason at 12 Weeks Abemaciclib discontinued for any reason by 12 weeks	6 Participants
Number of Participants Who Discontinued Abemaciclib Treatment for Any Reason at 12 Weeks Abemaciclib not discontinued within 12 weeks of treatment	83 Participants

SECONDARY outcome

Timeframe: 3 months (12 weeks)

Number of participants with abemaciclib dose reductions at 3 months (12 weeks)

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants With Abemaciclib Dose Reductions at 12 Weeks Abemaciclib dose not reduced within 12 weeks	77 Participants
Number of Participants With Abemaciclib Dose Reductions at 12 Weeks Abemaciclib dose reduction by 12 weeks	12 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Subjects who received at least one dose of abemaciclib

Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent diarrhea adverse event reported per subject (across any dose level received) between the start of treatment and up to 24 weeks. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib. Grade 0 - no toxicity reported Grade 1 - mild Grade 2 - moderate Grade 3 - severe Grade 4 - life-threatening Grade 5 - fatal (no cases of grade 5 diarrhea to report)

Outcome measures

Outcome measures
Measure	Abemaciclib n=90 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Weeks Grade 0 (no toxicity) or 1 (mild) diarrhea	60 Participants
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Weeks Grade 2 (moderate) diarrhea	25 Participants
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Weeks Grade 3 (severe) diarrhea	5 Participants
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Weeks Grade 4 (life-threatening) diarrhea	0 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Subjects who received at least one dose of abemaciclib

Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent adverse event (of any kind) reported per subject (across any dose level received) between the start of treatment and up to 24 weeks. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib. Grade 0 - no toxicity reported Grade 1 - mild Grade 2 - moderate Grade 3 - severe Grade 4 - life-threatening Grade 5 - fatal (no cases of grade 5 toxicities)

Outcome measures

Outcome measures
Measure	Abemaciclib n=90 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Adverse Events by 24 Weeks Grade 0 (no toxicity reported) or 1 (mild)	13 Participants
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Adverse Events by 24 Weeks Grade 2 (moderate)	51 Participants
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Adverse Events by 24 Weeks Grade 3 (severe)	25 Participants
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Adverse Events by 24 Weeks Grade 4 (life-threatening)	1 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: Subjects who received at least one dose of abemaciclib and did not progress within 24 weeks of starting treatment. One (1) subject had a progression event within 24 weeks of starting treatment (the same subject excluded from the primary endpoint analysis at 12 weeks). Therefore, this subject is excluded from this secondary endpoint analysis.

The composite endpoint at 24 weeks is the number and proportion of participants with abemaciclib (abema) treatment discontinuations and/or abemaciclib dose reductions and/or participant inability to reach the target dose (full dose 150 mg BID) of abemaciclib at 24 weeks.

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Weeks Abema dose discontinuation, dose reduction, or inability to reach/maintain full dose by 24 weeks	42 Participants
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Weeks Reached and maintained abema full dose by 24 weeks	47 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Number of participants unable to reach the full dose will be reported as the rate of participants who have never reached the full dose of abemaciclib at 150mg BID by 24 weeks.

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants Unable to Reach the Full Dose by 24 Weeks Abemaciclib full dose never reached within 24 weeks	12 Participants
Number of Participants Unable to Reach the Full Dose by 24 Weeks Abemaciclib full dose reached at some point within 24 weeks	77 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Number of Participants who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks (6 months)

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants Who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks Abemaciclib discontinued for any reason by 24 weeks	16 Participants
Number of Participants Who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks Abemaciclib not discontinued within 24 weeks of treatment	73 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Number of Participants with Abemaciclib Dose Reductions at 24 Weeks (6 months)

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants With Abemaciclib Dose Reductions at 24 Weeks Abemaciclib dose reduction by 24 weeks	29 Participants
Number of Participants With Abemaciclib Dose Reductions at 24 Weeks Abemaciclib dose not reduced within 24 weeks	60 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Number of participants who reached the full dose of abemaciclib (150mg BID) but then had a dose reduction by 24 weeks

Outcome measures

Outcome measures
Measure	Abemaciclib n=89 Participants The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Weeks Dose reduction after reaching full dose (150mg) within 24 weeks	22 Participants
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Weeks Either reached and maintained full dose (150mg) or never reached full dose	67 Participants

Serious adverse events
Measure	Abemaciclib n=90 participants at risk The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards. Note: TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level. Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Cardiac disorders Pericardial effusion	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Diarrhea	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Lung infection	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Renal and urinary disorders Chronic kidney disease	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Sore throat	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Vascular disorders Thromboembolic event	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.

Other adverse events

Other adverse events
Measure	Abemaciclib n=90 participants at risk The dose escalation strategy utilizes Abemaciclib dose levels of 50mg BID x 2 weeks, then 100mg bid x 2 weeks, then 150mg bid from C2D1 and onwards. Note: TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level. Study procedures will be conducted as follows: * Cycles 1 - 24 * Days 1 - 28 of 28-day cycle: Predetermined dose of Abemaciclib 2 x per day. * Endocrine therapy 1 x per day. * In clinic visits with blood tests, questionnaires, and assessments: * Day 1 of Cycles 1, 2, and 3 * Day 15 of Cycles 1 and 2 * Every three cycles after Cycle 3 Day 1. * End of treatment visit with blood tests, questionnaires, assessments, and stool sample collection. Abemaciclib: CDK4 and CDK6 inhibitor, tablet taken orally Tamoxifen: Selective estrogen receptor modulator, taken orally per institutional standard of care Anastrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Letrozole: Non-steroidal aromatase inhibitor, taken orally per institutional standard of care Exemestane: Steroidal aromatase inhibitor, taken orally per institutional standard of care LHRH Agonist: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Blood and lymphatic system disorders Anemia	8.9% 8/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Cardiac disorders Mitral valve disease	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Cardiac disorders Sinus tachycardia	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Ear and labyrinth disorders Vertigo	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Eye disorders Blurred vision	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Eye disorders Eye disorders - Other, specify	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Abdominal pain	11.1% 10/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Anal fissure	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Constipation	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Diarrhea	32.2% 29/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Dry mouth	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Dyspepsia	5.6% 5/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Flatulence	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Gastroesophageal reflux disease	3.3% 3/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Gastrointestinal pain	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Hemorrhoids	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Mucositis oral	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Nausea	10.0% 9/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Oral hemorrhage	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Rectal hemorrhage	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Stomach pain	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Gastrointestinal disorders Vomiting	3.3% 3/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
General disorders and administration site conditions Edema limbs	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
General disorders and administration site conditions Fatigue	26.7% 24/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
General disorders and administration site conditions Flu like symptoms	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
General disorders and administration site conditions Non-cardiac chest pain	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
General disorders and administration site conditions Pain	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Immune system disorders Allergic reaction	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Breast infection	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Folliculitis	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Infections and infestations - Other, specify	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Lung infection	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Nail infection	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Otitis media	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Rhinitis infective	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Sinusitis	3.3% 3/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Skin infection	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Upper respiratory infection	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Urinary tract infection	5.6% 5/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Infections and infestations Vaginal infection	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Investigations Alanine aminotransferase increased	3.3% 3/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Investigations Aspartate aminotransferase increased	4.4% 4/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Investigations Creatinine increased	3.3% 3/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Investigations INR increased	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Investigations Lymphocyte count decreased	12.2% 11/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Investigations Neutrophil count decreased	31.1% 28/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Investigations White blood cell decreased	16.7% 15/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Metabolism and nutrition disorders Anorexia	6.7% 6/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Metabolism and nutrition disorders Hyperglycemia	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Metabolism and nutrition disorders Hypocalcemia	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Metabolism and nutrition disorders Hypokalemia	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Metabolism and nutrition disorders Hypophosphatemia	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Musculoskeletal and connective tissue disorders Back pain	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Musculoskeletal and connective tissue disorders Muscle cramp	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Nervous system disorders Dizziness	3.3% 3/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Nervous system disorders Dysgeusia	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Nervous system disorders Headache	6.7% 6/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Nervous system disorders Nystagmus	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Nervous system disorders Peripheral sensory neuropathy	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Nervous system disorders Vasovagal reaction	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Psychiatric disorders Anxiety	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Psychiatric disorders Depression	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Psychiatric disorders Insomnia	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Renal and urinary disorders Chronic kidney disease	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Reproductive system and breast disorders Breast pain	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Reproductive system and breast disorders Vaginal dryness	4.4% 4/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Reproductive system and breast disorders Vaginal hemorrhage	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 3/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 6/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.6% 5/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Surgical and medical procedures Surgical and medical procedures - Other, specify	1.1% 1/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Vascular disorders Hot flashes	6.7% 6/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Vascular disorders Hypertension	16.7% 15/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.
Vascular disorders Thromboembolic event	2.2% 2/90 • Time from first dose of abemaciclib to 24 weeks after first dose (6 months). Regular investigator assessment. Adverse events are reported across all dose levels combined (Abemaciclib 50 mg, 100 mg, and 150 mg). TRADE is a single arm phase 2 study; it does not contain separate arms or groups. All patients underwent a brief dose abemaciclib escalation. All endpoints, including adverse events, were designed to be evaluated in the entire single-arm study population, not at each week of dose escalation. Therefore, it is not possible to report adverse events per dose level.

Additional Information

Erica Mayer, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place