Trial Outcomes & Findings for Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis (NCT NCT03691493)
NCT ID: NCT03691493
Last Updated: 2025-02-17
Results Overview
Response rate will be estimated as the number of responders divided by the number of patients evaluated for response. Among patients who present with pain, responders will be considered those patients who have a 2 point decrease in the Brief Pain Inventory (BPI), and among those who do not present with pain (radiotherapy due to risk of unstable fracture or cord compression), responders will be considered those without development of a pathologic fracture or neurologic compromise (cord compression) due to cancer on imaging.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Up to 3 months post radiation
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Radiation, Palbociclib, Hormone Therapy
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Radiation, Palbociclib, Hormone Therapy
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
Baseline characteristics by cohort
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months post radiationResponse rate will be estimated as the number of responders divided by the number of patients evaluated for response. Among patients who present with pain, responders will be considered those patients who have a 2 point decrease in the Brief Pain Inventory (BPI), and among those who do not present with pain (radiotherapy due to risk of unstable fracture or cord compression), responders will be considered those without development of a pathologic fracture or neurologic compromise (cord compression) due to cancer on imaging.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=35 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Response Rate
Responders
|
29 Participants
|
—
|
—
|
—
|
|
Response Rate
Non-responders
|
6 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months post radiationPopulation: 27 participants were evaluable
Response rate will be estimated as the number of responders divided by the number of patients evaluated for response. Among patients who present with pain, responders will be considered those patients who fulfill the International Bone Consensus response criteria using the BPI item rating maximum pain over the last 3 days at the index site and analgesic usage for the treated site within the last 24 hours prior to assessment. Among patients who do not present with pain (radiotherapy due to risk of unstable fracture or cord compression), responders will be considered those without development of a new pathologic fracture or worsening neurologic compromise (cord compression) due to cancer on imaging.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=27 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria
Responders
|
18 Participants
|
—
|
—
|
—
|
|
Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria
Non-responders
|
2 Participants
|
—
|
—
|
—
|
|
Response Rate Incorporating BPI and Analgesic Measures According to International Bone Consensus Guideline Criteria
Intermediate
|
7 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months post radiationAdverse events, such as bone fracture following radiotherapy, any grade 3 toxicity (except neutropenia or leukopenia), grade 4 neutropenia, grade 4 leukopenia, grade 3 febrile neutropenia, or grade 3 brachial plexopathy or spinal cord injury, will be summarized descriptively.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
|
31 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 44 months post radiationPFS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
30.4 Months, estimated using the Kaplan-Meier
Interval 17.7 to
The upper limit for the 95% CI for median OS and PFS was not reached
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 44 months post radiationOS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
37.9 Months, estimated using the Kaplan-Meier
Interval 25.4 to
The upper limit for the 95% CI for median OS and PFS was not reached
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiationPopulation: Not all patients completed the measure at every timepoint.
Fatigue will be assessed before and after radiotherapy. The Multidimensional Fatigue Inventory (MFI) is a comprehensive self-report instrument designed to measure fatigue. It consists of 20 items rated on a 7-point scale and covers dimensions such as General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. Each question is score on a 1 to 5 scale, with 1 being 'yes, that is true' and 5 being 'No, that is not true'. The minimum score is 20 and the maximum score is100. The higher the score indicates fatigue.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)
Pre-radiation
|
55 Scores on a scale
Standard Deviation 16.4
|
—
|
—
|
—
|
|
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)
Last Day of radiation
|
53.6 Scores on a scale
Standard Deviation 13.8
|
—
|
—
|
—
|
|
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)
1-month post radiation
|
54.0 Scores on a scale
Standard Deviation 16.6
|
—
|
—
|
—
|
|
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)
3-month post radiation
|
52.3 Scores on a scale
Standard Deviation 15.9
|
—
|
—
|
—
|
|
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)
Change (Last Day of Radiation - Pre-radiation)
|
0.1 Scores on a scale
Standard Deviation 11.5
|
—
|
—
|
—
|
|
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)
Change (1-month post radiation - Pre-radiation)
|
-0.4 Scores on a scale
Standard Deviation 15.2
|
—
|
—
|
—
|
|
Fatigue as Measured by The Multidimensional Fatigue Inventory (MFI)
Change (3-month post radiation - Pre-radiation)
|
-1.4 Scores on a scale
Standard Deviation 12.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiationPopulation: Not all patients completed the measure at every timepoint.
Quality of life will be assessed before and after radiotherapy. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) Each scale is the weighted sum of the questions in their section and are directly transformed into a 0-100 scale i.e., the minimum score is 0, maximum is 100 A higher score indicates less disability Total score on the SF-36 is the summation of all the eight scales
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Quality of Life as Measured by Short Form Health Survey (SF-36)
3-month post radiation
|
44.0 Scores on a scale
Standard Deviation 8.2
|
—
|
—
|
—
|
|
Quality of Life as Measured by Short Form Health Survey (SF-36)
Pre-radiation
|
41.8 Scores on a scale
Standard Deviation 8.8
|
—
|
—
|
—
|
|
Quality of Life as Measured by Short Form Health Survey (SF-36)
Last Day of radiation
|
42.0 Scores on a scale
Standard Deviation 8.2
|
—
|
—
|
—
|
|
Quality of Life as Measured by Short Form Health Survey (SF-36)
1-month post radiation
|
44.0 Scores on a scale
Standard Deviation 8.1
|
—
|
—
|
—
|
|
Quality of Life as Measured by Short Form Health Survey (SF-36)
Change (Last Day of radiation - Pre-radiation)
|
0.2 Scores on a scale
Standard Deviation 4.7
|
—
|
—
|
—
|
|
Quality of Life as Measured by Short Form Health Survey (SF-36)
Change (1-month post radiation - Pre-radiation)
|
2.1 Scores on a scale
Standard Deviation 6.6
|
—
|
—
|
—
|
|
Quality of Life as Measured by Short Form Health Survey (SF-36)
Change (3-month post radiation - Pre-radiation)
|
1.9 Scores on a scale
Standard Deviation 7.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiationPopulation: Not all patients completed the measure at every timepoint.
Quality of life will be assessed before and after radiotherapy. EORTC QLQ-BM22 measures four multi-item scales: painful sites, functional interference, painful characteristics, and psychosocial aspects Each item is scaled from 1 (not at all) to 4 (very much) and directly transformed into a 0-100 scale A higher score in symptom scales indicates greater distress. A higher score in functional scales indicates greater functional ability
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
n=36 Participants
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
n=36 Participants
Evaluable, Functional Interference
|
Treated, Psychological Aspects
n=36 Participants
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
Pre-radiation
|
28.0 EORT QLQ-BM22 score
Standard Deviation 21.0
|
31.2 EORT QLQ-BM22 score
Standard Deviation 26.5
|
63.6 EORT QLQ-BM22 score
Standard Deviation 30.9
|
61.0 EORT QLQ-BM22 score
Standard Deviation 20.9
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
Last Day of radiation
|
21.5 EORT QLQ-BM22 score
Standard Deviation 20.0
|
25.0 EORT QLQ-BM22 score
Standard Deviation 23.7
|
73.4 EORT QLQ-BM22 score
Standard Deviation 25.8
|
68.4 EORT QLQ-BM22 score
Standard Deviation 19.8
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
1-month post radiation
|
18.5 EORT QLQ-BM22 score
Standard Deviation 15.1
|
22.2 EORT QLQ-BM22 score
Standard Deviation 24.6
|
74.1 EORT QLQ-BM22 score
Standard Deviation 26.6
|
69.9 EORT QLQ-BM22 score
Standard Deviation 21.7
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
3-month post radiation
|
17.7 EORT QLQ-BM22 score
Standard Deviation 14.4
|
18.1 EORT QLQ-BM22 score
Standard Deviation 16.6
|
74.8 EORT QLQ-BM22 score
Standard Deviation 21.0
|
68.1 EORT QLQ-BM22 score
Standard Deviation 23.3
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
Change (Last Day of radiation - Pre-radiation)
|
-6.5 EORT QLQ-BM22 score
Standard Deviation 14.1
|
-6.2 EORT QLQ-BM22 score
Standard Deviation 19.4
|
9.8 EORT QLQ-BM22 score
Standard Deviation 18.7
|
7.4 EORT QLQ-BM22 score
Standard Deviation 18.7
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
Change (1-month post radiation - Pre-radiation)
|
-9.4 EORT QLQ-BM22 score
Standard Deviation 15.7
|
-9.0 EORT QLQ-BM22 score
Standard Deviation 25.9
|
10.5 EORT QLQ-BM22 score
Standard Deviation 29.8
|
9.0 EORT QLQ-BM22 score
Standard Deviation 17.1
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
Change (3-month post radiation - Pre-radiation)
|
-10.7 EORT QLQ-BM22 score
Standard Deviation 15.8
|
-13.7 EORT QLQ-BM22 score
Standard Deviation 20.0
|
11.9 EORT QLQ-BM22 score
Standard Deviation 23.1
|
6.7 EORT QLQ-BM22 score
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiationPopulation: Not all patients completed the measure at every timepoint.
Quality of life will be assessed before and after radiotherapy. The EORTC QLQ-C15-PAL measures seven scales: physical functioning, global health status, emotional functioning, fatigue, nausea/vomiting, appetite loss, and constipation For questions 1-14, each item is scaled from 1 (not at all) to 4 (very much) . For question 15 (global QoL), patients respond to a seven-point numerical scale from 1 (very poor overall) to 7 (excellent overall). The scale is scored from 0 to 100. A higher score in symptom scales indicates greater distress. A higher score in functional scales indicates greater functional ability. A higher score in global health status indicates a high quality of life. Each subscore is computed using the Addendum to the EORTC QLQ-C30 Scoring Manual: Scoring of the EORTC QLQ-C15-PAL.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
n=36 Participants
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL)
Pre-radiation
|
72.7 EORTC QLQ-C15-PAL score
Standard Deviation 19.6
|
42.6 EORTC QLQ-C15-PAL score
Standard Deviation 28.9
|
—
|
—
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL)
Last Day of radiation
|
68.1 EORTC QLQ-C15-PAL score
Standard Deviation 20.5
|
32.4 EORTC QLQ-C15-PAL score
Standard Deviation 28.4
|
—
|
—
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL)
1-month post radiation
|
72.7 EORTC QLQ-C15-PAL score
Standard Deviation 20.4
|
28.7 EORTC QLQ-C15-PAL score
Standard Deviation 23.8
|
—
|
—
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL)
3-month post radiation
|
71.9 EORTC QLQ-C15-PAL score
Standard Deviation 20.5
|
28.6 EORTC QLQ-C15-PAL score
Standard Deviation 23.8
|
—
|
—
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL)
Change (Last Day of radiation - Pre-radiation)
|
-4.6 EORTC QLQ-C15-PAL score
Standard Deviation 21.3
|
-10.2 EORTC QLQ-C15-PAL score
Standard Deviation 25.3
|
—
|
—
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL)
Change (1-month post radiation - Pre-radiation)
|
0.0 EORTC QLQ-C15-PAL score
Standard Deviation 22.9
|
-13.9 EORTC QLQ-C15-PAL score
Standard Deviation 27.7
|
—
|
—
|
|
Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 for Palliative Care (EORTC QLQ-C15-PAL)
Change (3-month post radiation - Pre-radiation)
|
-0.5 EORTC QLQ-C15-PAL score
Standard Deviation 19.6
|
-13.8 EORTC QLQ-C15-PAL score
Standard Deviation 26.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiationPopulation: Not all patients completed the measure at every timepoint.
Depression will be assessed before and after radiotherapy. The Hospital Anxiety and Depression Scale (HADS) is a 14-item tool used to screen for anxiety and depression, which commonly coexist. The HADS produces a subscale for anxiety (HADS-A) and a separate subscale for depression (HADS-D). The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is out of 42, (21 per subscale) and the range is 0-42. Scores are derived by summing responses for each of the two subscales or for the scale as a whole. Higher scores indicate greater levels of anxiety or depression. The total HADS score may be regarded as a global measure of psychological distress.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
n=36 Participants
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)
Pre-radiation
|
4.9 HADS score, both depression and anxiety
Standard Deviation 3.5
|
6.1 HADS score, both depression and anxiety
Standard Deviation 3.6
|
—
|
—
|
|
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)
Last day of radiation
|
4.6 HADS score, both depression and anxiety
Standard Deviation 3.5
|
5.3 HADS score, both depression and anxiety
Standard Deviation 3.8
|
—
|
—
|
|
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)
1-month post radiation
|
4.3 HADS score, both depression and anxiety
Standard Deviation 3.5
|
5.2 HADS score, both depression and anxiety
Standard Deviation 3.6
|
—
|
—
|
|
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)
3-month post radiation
|
4.1 HADS score, both depression and anxiety
Standard Deviation 3.5
|
5.3 HADS score, both depression and anxiety
Standard Deviation 4.0
|
—
|
—
|
|
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)
Change (Last day of radiation - Pre-radiation)
|
-0.3 HADS score, both depression and anxiety
Standard Deviation 2.0
|
-0.8 HADS score, both depression and anxiety
Standard Deviation 1.9
|
—
|
—
|
|
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)
Change (1-month post radiation - Pre-radiation)
|
-0.6 HADS score, both depression and anxiety
Standard Deviation 2.6
|
-0.8 HADS score, both depression and anxiety
Standard Deviation 2.3
|
—
|
—
|
|
Depression as Measured by Hospital Anxiety and Depression Scale (HADS)
Change (3-month post radiation - Pre-radiation)
|
-0.7 HADS score, both depression and anxiety
Standard Deviation 3.5
|
-0.8 HADS score, both depression and anxiety
Standard Deviation 3.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-radiation on day 1, Last Day of radiation (5-10 days), 1 month post radiation, and 3 months post radiation, change last day of radiation, change 1 month post radiation, change 3 months post radiationPopulation: At each timepoint, there are a different number of patients analyzed due to missing data, patients that were lost to follow up or removed due to disease progression.
Adherence will be determined by number of days drug taken divided by number of days drug should have been taken over the time period of the study.
Outcome measures
| Measure |
Radiation, Palbociclib, Hormone Therapy
n=36 Participants
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
Letrozole: Given PO
Palbociclib: Given PO
Radiation Therapy: Undergo radiation therapy
Tamoxifen: Given PO
|
Treated, Pain Characteristics
n=36 Participants
Evaluable ,Pain Characteristics
|
Treated, Functional Interference
Evaluable, Functional Interference
|
Treated, Psychological Aspects
Evaluable, Psychological Aspects
|
|---|---|---|---|---|
|
Number of Participants With Adherence as Measured by Drug Diary
Pre-radiation
|
36 Participants
|
36 Participants
|
—
|
—
|
|
Number of Participants With Adherence as Measured by Drug Diary
Last Day of radiation
|
33 Participants
|
35 Participants
|
—
|
—
|
|
Number of Participants With Adherence as Measured by Drug Diary
1-month post radiation
|
25 Participants
|
29 Participants
|
—
|
—
|
|
Number of Participants With Adherence as Measured by Drug Diary
3-month post radiation
|
26 Participants
|
30 Participants
|
—
|
—
|
Adverse Events
Grade 1 Adverse Event
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Grade 2 Adverse Event
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Grade 3 Adverse Event
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Grade 4 Adverse Event
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Grade 5 Adverse Event
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Grade 1 Adverse Event
n=36 participants at risk
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
|
Grade 2 Adverse Event
n=36 participants at risk
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
|
Grade 3 Adverse Event
n=36 participants at risk
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
|
Grade 4 Adverse Event
n=36 participants at risk
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
|
Grade 5 Adverse Event
n=36 participants at risk
Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anastrozole: Given PO
Exemestane: Given PO
Fulvestrant: Given IM
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
12/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
General disorders
Anorexia
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Arm Pain
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Shoulder Pain
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
4/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Skin and subcutaneous tissue disorders
Dry Skin/Rash on Back
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
General disorders
Dyspnea
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
General disorders
Fatigue
|
30.6%
11/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
13.9%
5/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Gastrointestinal disorders
Gastroesophagealreflux disease
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decrease
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
22.2%
8/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
19.4%
7/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Gastrointestinal disorders
Mouth Sores
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Gastrointestinal disorders
Nausea
|
13.9%
5/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Blood and lymphatic system disorders
Neutrophil Count Decrease
|
19.4%
7/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
25.0%
9/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
36.1%
13/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Investigations
Platelet Count Decreased
|
22.2%
8/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Skin and subcutaneous tissue disorders
Skin Desquamation
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
3/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Metabolism and nutrition disorders
Weight Loss
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Investigations
White Blood Cell Decrease
|
25.0%
9/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
47.2%
17/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
33.3%
12/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Radiation
|
2.8%
1/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Skin and subcutaneous tissue disorders
Moderate erythema over sternum
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
|
Investigations
Any Grade 4 AE - excluding neutropenia and leukpenia
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
5.6%
2/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
0.00%
0/36 • All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place