Trial Outcomes & Findings for Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery (NCT NCT01082211)

Last Updated: 2022-06-21

Results Overview

Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible \& started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

From the end of radiation to 1 year.

Results posted on

2022-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	Partial Breast Re-Irradiation Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
Overall Study STARTED	65
Overall Study Has Baseline PT QOL Data	46
Overall Study Has Baseline MD QOL Data	44
Overall Study Has Baseline/12-month PT QOL Data	36
Overall Study Has Baseline/12-Month MD QOL Data	35
Overall Study Has Baseline/36-month PT QOL Data	32
Overall Study Has Baseline/36-Month MD QOL Data	27
Overall Study All Eligible Patients	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Partial Breast Re-Irradiation Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
Overall Study Protocol Violation	4
Overall Study No protocol treatment received	3

Baseline Characteristics

Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the end of radiation to 1 year.

Population: The first 55 eligible patients who completed treatment and achieved 1 year of follow-up.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=55 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events	1 participants	—	—

SECONDARY outcome

Timeframe: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

Population: All eligible patients.

The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
In-breast Recurrence	3.7 percentage of participants Interval 0.7 to 11.4	—	—

SECONDARY outcome

Timeframe: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

Population: All eligible patients.

Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Freedom From Mastectomy	5.2 percentage of participants Interval 1.3 to 13.1	—	—

SECONDARY outcome

Timeframe: Prior to the start of radiation and 3 weeks after last radiation treatment.

Population: Eligible patients who consented to participate in the CTC portion of the trial

CTCs in peripheral blood were assessed using the CellSearch (trademark) system. A stringent algorithm was used to classify cell images as a CTC. A CTC must express EpCAM \[epithelial cell adhesion molecule\] and not leukocyte lineage-specific antigens, exhibit cytoplasmic expression of cytokeratin, and contain a nucleus that binds DAPI \[4',6-doamidino-2-phenylindole\]. A cell image is not a CTC if any of the previous criterion are missing. A subject is categorized as "Detectable" if the patient had a CTC and "Undetectable" if the subject had no CTCs. If neither category could be determined, then the subject was categorized as "Unevaluable."

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=47 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) Pre-treatment · Detectable	8 Participants	—	—
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) Pre-treatment · Undetectable	32 Participants	—	—
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) Pre-treatment · Unevaluable	7 Participants	—	—
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) Post-treatment · Detectable	8 Participants	—	—
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) Post-treatment · Undetectable	26 Participants	—	—
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) Post-treatment · Unevaluable	13 Participants	—	—

SECONDARY outcome

Timeframe: From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis.

Population: All eligible patients

AEs were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The overall highest grade for each patient was computed from all reported adverse events definitely, probably, or possibly related to protocol treatment.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Treatment-related Adverse Events (AEs) Any Time Grade 5	0 percentage of participants	—	—
Treatment-related Adverse Events (AEs) Any Time Grade 4	0 percentage of participants	—	—
Treatment-related Adverse Events (AEs) Any Time Grade 3	10.3 percentage of participants	—	—
Treatment-related Adverse Events (AEs) Any Time Grade 2	32.8 percentage of participants	—	—
Treatment-related Adverse Events (AEs) Any Time Grade 1	41.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years.

Population: All eligible patients.

Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Distant Metastasis-free Survival	94.8 percentage of participants Interval 84.8 to 98.3	—	—

SECONDARY outcome

Timeframe: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

Population: All eligible patients.

Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Mastectomy-free Survival	89.7 percentage of participants Interval 78.4 to 95.2	—	—

SECONDARY outcome

Timeframe: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

Population: All eligible patients.

Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Overall Survival	94.8 percentage of participants Interval 84.8 to 98.3	—	—

SECONDARY outcome

Timeframe: After 1 year from the end of radiation.

Population: All eligible patients

AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=58 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation Grade 5	0 percentage of participants	—	—
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation Grade 4	0 percentage of participants	—	—
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation Grade 3	6.9 percentage of participants	—	—
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation Grade 2	22.4 percentage of participants	—	—
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation Grade 1	24.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and 12 months from the start of radiation treatment.

Population: Eligible patients who consented to participate in the quality of life study and have baseline and 12-month BCTOS data

The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 12 months minus the value at baseline. A positive change reflects a decline at 12 months and a negative change reflects an improvement at 12 months.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=36 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) Functional status	0.04 units on a scale Standard Deviation 0.41	—	—
Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmetic	0.09 units on a scale Standard Deviation 0.65	—	—
Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) Breast-specific pain	-0.21 units on a scale Standard Deviation 0.62	—	—

SECONDARY outcome

Timeframe: Baseline and 36 months from the start of radiation treatment.

Population: Eligible patients who consented to participate in the quality of life study and have baseline and 36-month BCTOS data

The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 36 months minus the value at baseline. A positive change reflects a decline at 36 months and a negative change reflects an improvement at 36 months.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=32 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) Functional status	-0.02 units on a scale Standard Deviation 0.47	—	—
Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmetic	0.19 units on a scale Standard Deviation 0.59	—	—
Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) Breast-specific pain	-0.20 units on a scale Standard Deviation 0.72	—	—

SECONDARY outcome

Timeframe: Baseline,12, and 36 Months from the start of radiation treatment.

Population: Eligible patients who consented to participate in the quality of life study and have baseline data

Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale: Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast. Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast. Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast. Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=46 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score Patient-Reported: 12-Month Breast-Specific Pain Score
Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale Baseline-Excellent/Good	26 Participants	—	—
Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale 12-Month-Excellent/Good	22 Participants	—	—
Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale 36-Month-Excellent/Good	14 Participants	—	—

SECONDARY outcome

Timeframe: 12 Months from the start of radiation treatment.

Population: Eligible patients who consented to participate in the quality of life study and have baseline and 12-month BCTOS data

Patient-Reported BCTOS is comprised of 3 subscales (functional status, cosmetic status, breast specific pain). Responses for each item form a 4-point Likert scale evaluating the differences between the treated and untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). Higher scores reflect poorer outcomes. Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale: Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast. Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast. Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast. Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue.

Outcome measures

Outcome measures
Measure	Partial Breast Re-Irradiation n=32 Participants Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total	Cosmetic Score n=32 Participants Patient-Reported: 12-Month Cosmetic Score	Breast-Specific Pain Score n=32 Participants Patient-Reported: 12-Month Breast-Specific Pain Score
12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale Physician 12-Month Score: Good	1.14 units on a scale Standard Deviation 0.25	1.88 units on a scale Standard Deviation 0.44	1.53 units on a scale Standard Deviation 0.45
12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale Physician 12-Month Score: Poor	1.06 units on a scale Standard Deviation 0.09	2.48 units on a scale Standard Deviation 1.21	2.50 units on a scale Standard Deviation 1.18
12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale Physician 12-Month Score: Excellent	1.03 units on a scale Standard Deviation 0.06	1.67 units on a scale Standard Deviation 0.57	1.33 units on a scale Standard Deviation 0.47
12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale Physician 12-Month Score: Fair	1.55 units on a scale Standard Deviation 0.53	2.19 units on a scale Standard Deviation 0.69	1.82 units on a scale Standard Deviation 0.77

Adverse Events

Partial Breast Re-Irradiation

Serious events: 3 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Partial Breast Re-Irradiation n=58 participants at risk Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.7% 1/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Multi-organ failure	1.7% 1/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain	1.7% 1/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.7% 1/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin induration	1.7% 1/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Surgical and medical procedures Surgical and medical procedures - Other, specify	1.7% 1/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Lymphedema	1.7% 1/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Other adverse events
Measure	Partial Breast Re-Irradiation n=58 participants at risk Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
Blood and lymphatic system disorders Anemia	5.2% 3/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	8.6% 5/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	55.2% 32/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Localized edema	13.8% 8/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain	20.7% 12/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Skin infection	8.6% 5/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation	29.3% 17/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Fracture	5.2% 3/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Seroma	10.3% 6/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia	5.2% 3/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 5/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Back pain	10.3% 6/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	27.6% 16/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	8.6% 5/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	32.8% 19/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	8.6% 5/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	5.2% 3/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Breast atrophy	22.4% 13/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Breast pain	36.2% 21/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	6.9% 4/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	10.3% 6/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.9% 4/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	5.2% 3/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Erythema multiforme	8.6% 5/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pruritus	6.9% 4/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	20.7% 12/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	50.0% 29/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin hypopigmentation	5.2% 3/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin induration	24.1% 14/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Telangiectasia	19.0% 11/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hot flashes	13.8% 8/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypertension	5.2% 3/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Lymphedema	13.8% 8/58 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER