Trial Outcomes & Findings for Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer (NCT NCT01556243)

Last Updated: 2023-11-30

Results Overview

Local recurrence(LR) defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years. The estimated 5-year cumulative incidence of LR will be reported as a percentage of patients expected to experience a LR at 5 years.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

270 participants

Primary outcome timeframe

5 years

Results posted on

2023-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Breast Conservation Surgery and Radiation Therapy Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.\>\> \>\> therapeutic conventional surgery\>\> \>\> whole breast irradiation
Overall Study STARTED	270
Overall Study COMPLETED	204
Overall Study NOT COMPLETED	66

Reasons for withdrawal

Reasons for withdrawal
Measure	Breast Conservation Surgery and Radiation Therapy Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.\>\> \>\> therapeutic conventional surgery\>\> \>\> whole breast irradiation
Overall Study Ineligible	34
Overall Study Converted to mastectomy	14
Overall Study Unable to achieve negative margins	2
Overall Study Withdrawal by Subject	16

Baseline Characteristics

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Conservation Surgery and Radiation Therapy n=270 Participants Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.\>\> \>\> therapeutic conventional surgery\>\> \>\> whole breast irradiation
Age, Continuous	60.5 years n=5 Participants
Sex: Female, Male Female	270 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	245 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	232 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: All patients that received protocol therapy and were evaluated for response

Outcome measures

Outcome measures
Measure	Breast Conservation Surgery and Radiation Therapy n=204 Participants Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.
Local Recurrence	3.1 percentage of participants Interval 1.3 to 6.4

SECONDARY outcome

Timeframe: 5 years

Population: There are only 198 patients in this analysis because it excludes those registered postoperatively

The conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting BCS; or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.

Outcome measures

Outcome measures
Measure	Breast Conservation Surgery and Radiation Therapy n=198 Participants Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.
Conversion Rate to Mastectomy	7.1 percentage of patients converted

SECONDARY outcome

Timeframe: Up to 30 days post-treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 17 months

Population: All eligible patients that received radiation therapy.

Radiation-related side effects of whole-breast radiation with a boost to 1 large or \> 1 lumpectomy site as assessed by NCI CTCAE version 4.0.

Outcome measures

Outcome measures
Measure	Breast Conservation Surgery and Radiation Therapy n=195 Participants Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.
Radiation-related Side Effects Grade 1	69 Participants
Radiation-related Side Effects Grade 2	74 Participants
Radiation-related Side Effects Grade 3	6 Participants

SECONDARY outcome

Timeframe: 24 months

Patient's perception of cosmesis will be assessed at their initial post-operative visit as well as 24 months following completion of WBI using the BREAST-Q subscales: satisfaction with breasts, satisfaction with overall outcome, and physical well-being. Patients registered after surgery will not partake in the pre-operative assessment but will be asked to complete subsequent cosmesis surveys. The total score for each of these subscales will be determined using the BREAST-Q scoring module (http://www.mskcc.org/mskcc/shared/Breast-Q/scoreBQ.html). The BREAST-Q has multiple domains, and each domain score is obtained by transforming the raw scale item responses with the Q-Score software program. Each domain results in an independent score from 0 to 100 (higher scores indicate greater satisfaction or quality of life).

Outcome measures

Outcome measures
Measure	Breast Conservation Surgery and Radiation Therapy n=216 Participants Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.
Patient's Perception of Cosmesis Good or excellent (50-100)	70.6 percentage of patients
Patient's Perception of Cosmesis Fair (25-50)	25.7 percentage of patients
Patient's Perception of Cosmesis Poor (0-25)	3.7 percentage of patients

Adverse Events

Breast Conservation Surgery and Radiation Therapy

Serious events: 8 serious events

Other events: 169 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Breast Conservation Surgery and Radiation Therapy n=251 participants at risk whole breast irradiation
Injury, poisoning and procedural complications Dermatitis radiation	2.0% 5/251 • Number of events 5 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Injury, poisoning and procedural complications Seroma	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Injury, poisoning and procedural complications Wound dehiscence	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Vascular disorders Hematoma	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.

Other adverse events

Other adverse events
Measure	Breast Conservation Surgery and Radiation Therapy n=251 participants at risk whole breast irradiation
Blood and lymphatic system disorders Anemia	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Blood and lymphatic system disorders Febrile neutropenia	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Cardiac disorders Heart failure	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Eye disorders Eye disorders - Other, specify	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Gastrointestinal disorders Nausea	0.80% 2/251 • Number of events 2 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
General disorders Edema trunk	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
General disorders Fatigue	8.0% 20/251 • Number of events 20 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
General disorders Localized edema	1.6% 4/251 • Number of events 4 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
General disorders Non-cardiac chest pain	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
General disorders Pain	3.2% 8/251 • Number of events 9 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Infections and infestations Breast infection	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Infections and infestations Lung infection	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Infections and infestations Skin infection	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Infections and infestations Urinary tract infection	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Infections and infestations Wound infection	3.6% 9/251 • Number of events 11 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Injury, poisoning and procedural complications Bruising	2.0% 5/251 • Number of events 5 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Injury, poisoning and procedural complications Dermatitis radiation	57.8% 145/251 • Number of events 146 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Injury, poisoning and procedural complications Postoperative hemorrhage	1.2% 3/251 • Number of events 3 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Injury, poisoning and procedural complications Seroma	19.9% 50/251 • Number of events 56 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Injury, poisoning and procedural complications Wound dehiscence	0.80% 2/251 • Number of events 2 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Investigations Weight loss	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Metabolism and nutrition disorders Hyperglycemia	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Musculoskeletal and connective tissue disorders Back pain	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	1.2% 3/251 • Number of events 3 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Musculoskeletal and connective tissue disorders Musculoskeletal, conn tissue - Oth spec	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Musculoskeletal and connective tissue disorders Neck pain	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Musculoskeletal and connective tissue disorders Pain in extremity	0.80% 2/251 • Number of events 2 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Nervous system disorders Paresthesia	1.2% 3/251 • Number of events 3 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Nervous system disorders Peripheral sensory neuropathy	0.80% 2/251 • Number of events 2 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Nervous system disorders Tremor	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Psychiatric disorders Depression	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Psychiatric disorders Insomnia	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Reproductive system and breast disorders Breast pain	5.2% 13/251 • Number of events 13 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Reproductive system and breast disorders Reproductive system and breast -Oth spec	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Respiratory, thoracic and mediastinal disorders Sore throat	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Dry skin	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Erythema multiforme	1.2% 3/251 • Number of events 3 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Erythroderma	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Pain of skin	1.2% 3/251 • Number of events 3 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Pruritus	2.4% 6/251 • Number of events 6 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	0.80% 2/251 • Number of events 2 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.2% 8/251 • Number of events 8 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Skin induration	0.80% 2/251 • Number of events 2 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Skin and subcutaneous tissue disorders Skin ulceration	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Vascular disorders Hematoma	1.2% 3/251 • Number of events 3 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Vascular disorders Hypertension	2.0% 5/251 • Number of events 5 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Vascular disorders Hypotension	0.40% 1/251 • Number of events 1 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.
Vascular disorders Lymphedema	6.0% 15/251 • Number of events 15 • Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months. All patients that were treated and evaluable for adverse events are included in this adverse events summary. All patients that were registered are included in the mortality summary.

Additional Information

Judy Boughey

Mayo Clinic

Phone: 507-266-9997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place