Trial Outcomes & Findings for A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy (NCT NCT03542175)
NCT ID: NCT03542175
Last Updated: 2025-12-08
Results Overview
Number of Dose Limiting Toxicities encountered at each dose level. The trial will be monitored using TITE-CRM. Assuming a model for the time to occurrence of toxic response as a function of dose, the method allows information from all enrolled patients to be used when allocating a new patient to a dose level.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
1 year
Results posted on
2025-12-08
Participant Flow
Participant milestones
| Measure |
Rucaparib 200 mg BID
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 200 mg QD
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg BID
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg QD
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 400 mg BID
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
5
|
16
|
2
|
|
Overall Study
COMPLETED
|
2
|
6
|
5
|
16
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy
Baseline characteristics by cohort
| Measure |
Rucaparib 200 mg BID
n=2 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 200 mg QD
n=6 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg BID
n=5 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg QD
n=16 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 400 mg BID
n=2 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=9 Participants
|
54 years
n=6 Participants
|
48 years
n=9 Participants
|
50 years
n=205 Participants
|
50 years
n=16 Participants
|
50 years
n=82 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
16 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
31 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
13 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
25 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
11 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
20 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
6 Participants
n=82 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
16 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
31 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of Dose Limiting Toxicities encountered at each dose level. The trial will be monitored using TITE-CRM. Assuming a model for the time to occurrence of toxic response as a function of dose, the method allows information from all enrolled patients to be used when allocating a new patient to a dose level.
Outcome measures
| Measure |
Rucaparib 200 mg BID
n=2 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 200 mg QD
n=6 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg BID
n=5 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg QD
n=16 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 400 mg BID
n=2 Participants
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
|---|---|---|---|---|---|
|
Dose Limiting Toxicities
|
1 Dose limiting toxicities
|
0 Dose limiting toxicities
|
3 Dose limiting toxicities
|
3 Dose limiting toxicities
|
1 Dose limiting toxicities
|
Adverse Events
Rucaparib 200 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Rucaparib 200 mg QD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Rucaparib 300 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Rucaparib 300 mg QD
Serious events: 1 serious events
Other events: 16 other events
Deaths: 4 deaths
Rucaparib 400 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rucaparib 200 mg BID
n=2 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 200 mg QD
n=6 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg BID
n=5 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg QD
n=16 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 400 mg BID
n=2 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
|---|---|---|---|---|---|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
Other adverse events
| Measure |
Rucaparib 200 mg BID
n=2 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 200 mg QD
n=6 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg BID
n=5 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 300 mg QD
n=16 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
Rucaparib 400 mg BID
n=2 participants at risk
Treatment will consist of rucaparib at one dose level (200 mg BID, 200 mg QD, 300 mg BID, 300 mg QD or 400 mg BID) concurrently with a 6-week course of radiotherapy and 4 additional weeks of maintenance rucaparib at the same dose level.
Radiotherapy will consist of 50 Gy in 2 Gy per fraction to the breast or chest wall with or without regional nodes plus a 10 Gy boost to the lumpectomy cavity, to a total dose of 60 Gy. A 10 Gy boost to the post-mastectomy scar is allowed at the discretion of the treating physician.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Infections and infestations
Shingles
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
18.8%
3/16 • 1 year
|
50.0%
1/2 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Investigations
Weight loss
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Reproductive system and breast disorders
Breast atrophy
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
50.0%
1/2 • 1 year
|
66.7%
4/6 • 1 year
|
60.0%
3/5 • 1 year
|
75.0%
12/16 • 1 year
|
50.0%
1/2 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
50.0%
1/2 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Infections and infestations
Eye infection
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
General disorders
Fatigue
|
0.00%
0/2 • 1 year
|
50.0%
3/6 • 1 year
|
0.00%
0/5 • 1 year
|
18.8%
3/16 • 1 year
|
50.0%
1/2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Left chest wall tightness
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Left rotator cuff tear
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Vascular disorders
Lymphedema
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
12.5%
2/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Injury, poisoning and procedural complications
Moist Desquamation
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
50.0%
1/2 • 1 year
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
General disorders
Pain
|
0.00%
0/2 • 1 year
|
50.0%
3/6 • 1 year
|
0.00%
0/5 • 1 year
|
12.5%
2/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
12.5%
2/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
50.0%
1/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
6.2%
1/16 • 1 year
|
50.0%
1/2 • 1 year
|
|
Injury, poisoning and procedural complications
Radiation skin reaction
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
20.0%
1/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Gastrointestinal disorders
Receding gum lower center jaw
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis (scalp)
|
50.0%
1/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Gastrointestinal disorders
Aguesia
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/5 • 1 year
|
6.2%
1/16 • 1 year
|
0.00%
0/2 • 1 year
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/2 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/16 • 1 year
|
0.00%
0/2 • 1 year
|
Additional Information
Dr. Atif Khan, MD
Memorial Sloan Kettering Cancer Center
Phone: 848-225-6334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place