Trial Outcomes & Findings for A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (NCT NCT04539938)
NCT ID: NCT04539938
Last Updated: 2026-03-23
Results Overview
Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per investigator according to RECIST v1.1. For a response to be considered confirmed, the subsequent response had to be at least 4 weeks after the initial response. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR: a greater than equal to (\>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 95% exact confidence interval (CI) was based on Clopper-Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
From the first dose of study treatment until the first documented PD or before start of any new anti-cancer therapy (up to 43 months)
Results posted on
2026-03-23
Participant Flow
Participants diagnosed with unresectable locally advanced or metastatic (LA/M) human epidermal growth factor receptor 2 positive (HER2+) breast cancer (BC) with or without brain metastases, who received prior treatment with a taxane and trastuzumab or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including a taxane and trastuzumab (with or without pertuzumab) were enrolled at 24 sites in the United States.
A total of 94 participants were screened of which 24 failed screening, and 70 participants were enrolled in the study. Participants who continued to receive clinical benefit after end of study could continue to receive study treatment during the long-term extension phase (LTEP).
Participant milestones
| Measure |
Total Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300 milligram (mg) orally (PO) twice daily (BID) on Days 1 to 21 and Trastuzumab Deruxtecan (T-DXd) 5.4 milligram per kilogram (mg/kg) intravenous (IV) on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, progressive disease (PD), investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
| Measure |
Total Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300 milligram (mg) orally (PO) twice daily (BID) on Days 1 to 21 and Trastuzumab Deruxtecan (T-DXd) 5.4 milligram per kilogram (mg/kg) intravenous (IV) on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, progressive disease (PD), investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Overall Study
Death
|
36
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Sites terminated
|
22
|
|
Overall Study
Continued to LTEP
|
8
|
Baseline Characteristics
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Age, Continuous
|
55.5 Years
STANDARD_DEVIATION 13.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
|
Presence or history of treated or untreated brain metastases
Yes
|
27 Participants
n=10 Participants
|
|
Presence or history of treated or untreated brain metastases
No
|
43 Participants
n=10 Participants
|
|
HER2 testing results
Immunohistochemistry (IHC) 3 plus (+)
|
41 Participants
n=10 Participants
|
|
HER2 testing results
IHC 2+ and/or Fluorescence in situ hybridization +
|
28 Participants
n=10 Participants
|
|
HER2 testing results
Other
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study treatment until the first documented PD or before start of any new anti-cancer therapy (up to 43 months)Population: Response-evaluable analysis set included all participants with measurable disease who (1) had a baseline disease assessment, (2) received at least one dose of study drug (tucatinib and/or trastuzumab deruxtecan), and (3) had at least 1 post-baseline assessment or discontinued treatment due to PD, clinical progression, toxicity, or death.
Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per investigator according to RECIST v1.1. For a response to be considered confirmed, the subsequent response had to be at least 4 weeks after the initial response. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). PR: a greater than equal to (\>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 95% exact confidence interval (CI) was based on Clopper-Pearson method.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Confirmed Objective Response Rate (cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 According to Investigator (INV) Assessment
|
51.4 Percentage of participants
Interval 39.2 to 63.6
|
SECONDARY outcome
Timeframe: From the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first (approximately 46.2 months of treatment exposure)Population: The all treated participants includes all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
PFS as per INV was defined as the time from the start of the study treatment to the first documentation of PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Kaplan-Meier methods was used for analysis.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Progression-Free Survival (PFS) Per RECIST v1.1 According to INV
|
11.5 Months
Interval 7.5 to 14.1
|
SECONDARY outcome
Timeframe: From the first documented objective response until the first documentation of PD or death, whichever occurred first (approximately 46.2 months)Population: The response-evaluable analysis set included all participants with measurable disease who (1) had a baseline disease assessment, (2) received at least one dose of study drug (tucatinib and/or trastuzumab deruxtecan), and (3) had at least 1 post-baseline assessment or discontinued treatment due to PD, clinical progression, toxicity, or death.
DOR was defined as the time from the date of first documented objective response (CR or PR that was subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death due to any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: a \>= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Kaplan-Meier methods was used for analysis.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Duration of Response (DOR) Per RECIST v1.1 According to INV
|
11.9 Months
Interval 6.0 to
The upper limit of 95% confidence interval (CI) is not estimable due to the small number of participants with objective response, and the small number of PFS events among participants with objective response.
|
SECONDARY outcome
Timeframe: From first dose of study treatment until PD or death, whichever occurred first (approximately 46.2 months)Population: The response-evaluable analysis set included all participants with measurable disease who (1) had a baseline disease assessment, (2) received at least one dose of study drug (tucatinib and/or trastuzumab deruxtecan), and (3) had at least 1 post-baseline assessment or discontinued treatment due to PD, clinical progression, toxicity, or death.
DCR was defined as percentage of participants with confirmed CR, PR or stable disease (\[SD\] or non-CR/non-PD) per RECIST v1.1. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: a \>= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. 95% CI was computed using Clopper-Pearson method.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Disease Control Rate (DCR) Per RECIST v1.1
|
94.3 Percentage of participants
Interval 86.0 to 98.4
|
SECONDARY outcome
Timeframe: From date of start of study treatment until date of death or censoring date (approximately 46.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
OS was defined as the time from the start of study treatment to the date of death due to any cause. Participants who were not known to have died at the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). For participants without data beyond the day of treatment initiation, OS was censored on the date of treatment initiation. Kaplan-Meier methods was used for analysis.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Overall Survival (OS)
|
28.4 Months
Interval 20.9 to 36.2
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product which did not necessarily have a causal relationship with this treatment. AEs included all non-serious adverse events (non-SAEs) and SAEs. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
70 Participants
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
An SAE was an AE that at any dose, met any of the following criteria: resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability (substantial disruption of the participant's ability to conduct normal life functions), congenital anomaly/birth defect or considered medically significant.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
25 Participants
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. AEs were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 where, grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events Based on Severity
Grade 3
|
38 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events Based on Severity
Grade 1
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events Based on Severity
Grade 2
|
17 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events Based on Severity
Grade 4
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events Based on Severity
Grade 5
|
3 Participants
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Relatedness of AEs to study treatment was determined by the investigator.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With Treatment Related TEAEs
|
67 Participants
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
Laboratory abnormalities included: hematology; hemoglobin increased and decreased, leukocytes decreased, lymphocytes increased and decreased, neutrophils decreased and platelets decreased. Chemistry: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatinine, magnesium, potassium, sodium and total bilirubin increased and glucose, magnesium, potassium and sodium decreased. Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Laboratory test results were graded according to NCI CTCAE version 4.03, where Grade 0: no AE, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with any grade are reported in this outcome measure.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Hemoglobin decreased
|
48 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Hemoglobin increased
|
1 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Leukocytes decreased
|
41 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Lymphocytes decreased
|
32 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Lymphocytes increased
|
2 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Neutrophils decreased
|
34 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Platelets decreased
|
21 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Alanine Aminotransferase increased
|
35 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Alkaline Phosphatase increased
|
28 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Aspartate Aminotransferase increased
|
38 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Creatinine increased
|
29 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Glucose decreased
|
9 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Magnesium decreased
|
25 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Magnesium increased
|
4 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Potassium decreased
|
34 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Potassium increased
|
3 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Sodium decreased
|
10 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Sodium increased
|
12 Participants
|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities
Total Bilirubin increased
|
16 Participants
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Dose modification included dose reduction, dose delay, dose hold and dose interruption. Number of participants with TEAEs leading to any type of dose modification for tucatinib and T-DXd are reported in this outcome measure.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With TEAEs Leading to Dose Modification
TEAEs leading to Tucatinib dose modification
|
47 Participants
|
|
Number of Participants With TEAEs Leading to Dose Modification
TEAEs leading to T-DXd dose modification
|
39 Participants
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. In this outcome measure, participants with TEAEs leading to discontinuation of tucatinib and T-DXd treatment is reported.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With TEAEs Leading to Treatment Discontinuation
Participants who discontinued tucatinib due to TEAE
|
15 Participants
|
|
Number of Participants With TEAEs Leading to Treatment Discontinuation
Participants who discontinued T-DXd due to TEAE
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Cardiac ejection fraction was assessed using multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO). Baseline was defined as most recent non-missing assessment on or before first dose date. Number of participants according to change from baseline in ejection fraction categories (i.e., no decrease, decrease \<10%, decrease 10-\<20% and decrease \>=20%) is reported in this outcome measure.
Outcome measures
| Measure |
Total Participants
n=64 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants According to Change From Baseline Categories in Ejection Fraction
Decrease 10 - < 20%
|
4 Participants
|
|
Number of Participants According to Change From Baseline Categories in Ejection Fraction
Decrease >= 20%
|
0 Participants
|
|
Number of Participants According to Change From Baseline Categories in Ejection Fraction
No decrease
|
31 Participants
|
|
Number of Participants According to Change From Baseline Categories in Ejection Fraction
Decrease < 10%
|
29 Participants
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months)Population: The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
Vital signs included body temperature, respiratory rate, heart rate, oxygen saturation, and systolic blood pressure (SBP) and diastolic blood pressure (DBP). The clinically significant vital signs were defined as: heart rate \> 100 beats per minute (bpm), temperature \>=38.0 degrees Celsius (C), respiratory rate \> 20 breaths per minute and oxygen saturation \< 88%; SBP \>=120 millimeters of mercury (mmHg) or DBP \>=80 mmHg; SBP \>=140 mmHg or DBP \>=90 mmHg and SBP \>=160 mmHg or DBP\>=100 mmHg.
Outcome measures
| Measure |
Total Participants
n=70 Participants
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Number of Participants With Clinically Significant Vital Signs
Temperature >= 38 degrees C
|
1 Participants
|
|
Number of Participants With Clinically Significant Vital Signs
SBP >= 120mmHg or DBP >= 80 mmHg
|
66 Participants
|
|
Number of Participants With Clinically Significant Vital Signs
SBP >= 140 mmHg or DBP >= 90 mmHg
|
39 Participants
|
|
Number of Participants With Clinically Significant Vital Signs
SBP >= 160 mmHg or DBP >= 100 mmHg
|
7 Participants
|
|
Number of Participants With Clinically Significant Vital Signs
Respiratory Rate > 20 breaths per minute
|
4 Participants
|
|
Number of Participants With Clinically Significant Vital Signs
Heart Rate > 100 bpm
|
27 Participants
|
|
Number of Participants With Clinically Significant Vital Signs
Oxygen Saturation < 88 %
|
1 Participants
|
Adverse Events
Total Participants
Serious events: 25 serious events
Other events: 70 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Total Participants
n=70 participants at risk
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Cardiac disorders
Ventricular fibrillation
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Enterocolitis
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/70 • Number of events 2 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/70 • Number of events 2 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
General disorders
Fatigue
|
2.9%
2/70 • Number of events 2 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Pneumonia
|
4.3%
3/70 • Number of events 3 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Tooth infection
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Injury, poisoning and procedural complications
Overdose
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Nervous system disorders
Brain oedema
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
4.3%
3/70 • Number of events 3 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Vascular disorders
Haematoma
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Number of events 1 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
Other adverse events
| Measure |
Total Participants
n=70 participants at risk
Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.4%
8/70 • Number of events 9 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
5/70 • Number of events 16 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Eye disorders
Dry eye
|
7.1%
5/70 • Number of events 6 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Eye disorders
Vision blurred
|
15.7%
11/70 • Number of events 12 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
9/70 • Number of events 16 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Constipation
|
54.3%
38/70 • Number of events 62 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Diarrhoea
|
80.0%
56/70 • Number of events 108 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
6/70 • Number of events 6 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
7/70 • Number of events 8 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
5/70 • Number of events 7 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Nausea
|
77.1%
54/70 • Number of events 93 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
10/70 • Number of events 13 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
42/70 • Number of events 68 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
General disorders
Chills
|
10.0%
7/70 • Number of events 7 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
General disorders
Fatigue
|
71.4%
50/70 • Number of events 64 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
General disorders
Influenza like illness
|
7.1%
5/70 • Number of events 6 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
General disorders
Malaise
|
5.7%
4/70 • Number of events 5 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
General disorders
Oedema peripheral
|
11.4%
8/70 • Number of events 10 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
General disorders
Pyrexia
|
10.0%
7/70 • Number of events 9 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
COVID-19
|
15.7%
11/70 • Number of events 11 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Conjunctivitis
|
5.7%
4/70 • Number of events 4 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Sinusitis
|
5.7%
4/70 • Number of events 9 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
10/70 • Number of events 14 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Infections and infestations
Urinary tract infection
|
24.3%
17/70 • Number of events 34 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
7/70 • Number of events 7 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
7/70 • Number of events 10 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
6/70 • Number of events 8 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Investigations
Blood bilirubin increased
|
7.1%
5/70 • Number of events 12 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Investigations
Blood creatinine increased
|
7.1%
5/70 • Number of events 8 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Investigations
Neutrophil count decreased
|
11.4%
8/70 • Number of events 12 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Investigations
Weight decreased
|
21.4%
15/70 • Number of events 16 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Investigations
Weight increased
|
5.7%
4/70 • Number of events 4 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.7%
25/70 • Number of events 33 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Metabolism and nutrition disorders
Dehydration
|
11.4%
8/70 • Number of events 18 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
20/70 • Number of events 29 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.7%
11/70 • Number of events 22 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.7%
11/70 • Number of events 15 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
9/70 • Number of events 10 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.4%
8/70 • Number of events 9 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
7/70 • Number of events 12 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.7%
4/70 • Number of events 5 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.6%
6/70 • Number of events 10 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Nervous system disorders
Dizziness
|
14.3%
10/70 • Number of events 14 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Nervous system disorders
Dysgeusia
|
11.4%
8/70 • Number of events 8 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Nervous system disorders
Headache
|
30.0%
21/70 • Number of events 34 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.7%
11/70 • Number of events 11 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Psychiatric disorders
Insomnia
|
11.4%
8/70 • Number of events 8 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Renal and urinary disorders
Dysuria
|
5.7%
4/70 • Number of events 4 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
5/70 • Number of events 5 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
14/70 • Number of events 17 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.9%
9/70 • Number of events 10 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.4%
8/70 • Number of events 12 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
7/70 • Number of events 7 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.6%
6/70 • Number of events 7 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.7%
4/70 • Number of events 4 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.7%
18/70 • Number of events 18 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.7%
4/70 • Number of events 4 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
5/70 • Number of events 16 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
4/70 • Number of events 5 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Vascular disorders
Hot flush
|
11.4%
8/70 • Number of events 10 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
|
Vascular disorders
Hypotension
|
5.7%
4/70 • Number of events 7 • From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER