A Phase 2 interventional study of therapeutic conventional surgery and whole breast irradiation in Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 350 sites in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 270 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Registration Inclusion Criteria:
Female Gender - Men are excluded from this study. Male breast cancer is a rare event.
Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.
Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.
Foci of Breast Cancer
4.1 Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue.
4.2 Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).
No more than 2 quadrants with biopsy proven breast cancer.
4.3 Note: The shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained.
4.4 Note: Patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI).
4.5 Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only.
4.6 Fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy.
4.7 Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.
Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:
5.1 An area of atypia > 2cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC. OR
5.2 Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology.
Mammogram Imaging - Bilateral mammogram ≤ 90 days prior to date of surgery.
6.1 Note: For patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment.
Registration Exclusion Criteria:
Pregnancy, Nursing and Requirement for Contraception - Pregnant women, nursing women and women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) are excluded from participation.
This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects.
14.1 Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
14.2 Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
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.
Procedure: therapeutic conventional surgery · Radiation: whole breast irradiation
Local Recurrence
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.
Time frame: 5 years
Conversion Rate to Mastectomy
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.
Time frame: 5 years
Severity of Adverse Effects
Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event.
Time frame: 17 monhts
Radiation-related Side Effects
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.
Time frame: 17 months
Patient's Perception of Cosmesis
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).
Time frame: 24 months
| Milestone | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Started | 270 |
| Completed | 204 |
| Not completed | 66 |
| Withdrew: Ineligible | 34 |
| Withdrew: Converted to mastectomy | 14 |
| Withdrew: Unable to achieve negative margins | 2 |
| Withdrew: Withdrawal by subject | 16 |
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.
| percentage of participants | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Local Recurrence | 3.1 (1.3 to 6.4) |
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.
| percentage of patients converted | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Conversion Rate to Mastectomy | 7.1 |
Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event.
| percentage of patients | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Severity of Adverse Effects | 4.8 |
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.
| Participants | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Grade 1 | 69 |
| Grade 2 | 74 |
| Grade 3 | 6 |
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).
| percentage of patients | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Good or excellent (50-100) | 70.6 |
| Fair (25-50) | 25.7 |
| Poor (0-25) | 3.7 |
Collected over Adverse events were followed for a maximum of 17.1 months and mortality was followed for a maximum of 90.6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breast Conservation Surgery and Radiation Therapy | 9/270 (3.3%) | 8/251 (3.2%) | 169/251 (67.3%) |
| Event | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Dermatitis radiationInjury, poisoning and procedural complications | 5/251 |
| SeromaInjury, poisoning and procedural complications | 1/251 |
| Wound dehiscenceInjury, poisoning and procedural complications | 1/251 |
| HematomaVascular disorders | 1/251 |
| Event | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Dermatitis radiationInjury, poisoning and procedural complications | 145/251 |
| SeromaInjury, poisoning and procedural complications | 50/251 |
| FatigueGeneral disorders and administration site conditions | 20/251 |
| LymphedemaVascular disorders | 15/251 |
| Breast painReproductive system and breast disorders | 13/251 |
| Wound infectionInfections and infestations | 9/251 |
| PainGeneral disorders and administration site conditions | 8/251 |
| Skin hyperpigmentationSkin and subcutaneous tissue disorders | 8/251 |
| PruritusSkin and subcutaneous tissue disorders | 6/251 |
| BruisingInjury, poisoning and procedural complications | 5/251 |
| Age, Continuous(years) | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Median | 60.5 (40 to 87) |
| Sex: Female, Male(Participants) | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Female | 270 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 245 |
| Unknown or Not Reported | 16 |
| Race (NIH/OMB)(Participants) | Breast Conservation Surgery and Radiation Therapy |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 22 |
| White | 232 |
| More than one race | 0 |
| Unknown or Not Reported | 11 |
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Alliance for Clinical Trials in Oncology