Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage II breast cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage II breast cancer who have undergone mastectomy.

Detailed Description
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OBJECTIVES: Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive standard of care and observation only. After completion of study therapy, patients are followed up twice in the first year, and then annually for up to 10 years.

Official Title
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Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: standard follow-up care
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed unilateral invasive breast cancer pT1, pN1, M0 disease pT2, pN1, M0 disease pT2, pN0 disease with grade III histology and/or lymphovascular invasion Multifocal breast cancer meeting both of the following criteria: Largest discrete tumor ≥ 2 cm if N0 Grade III histology and/or lymphovascular invasion No bilateral breast cancer Axillary node negative status by axillary clearance, axillary node sampling, or sentinel node biopsy Patients with axillary node positive (1-3 positive nodes, including micrometastases* > 0.2 mm and ≤ 2 mm) must have had an axillary node clearance (minimum of 10 nodes removed) performed No more than 3 pathologically involved lymph nodes No internal mammary nodes visible on sentinel node scintigraphy in the absence of negative histology NOTE: *Isolated tumor cells not counted as micrometastases Underwent total mastectomy (with minimum of 1 mm margin clear of invasive cancer and DCIS) and axillary surgery with staging procedure Must have undergone adjuvant systemic chemotherapy if indicated for intermediate-risk breast cancer Patients undergoing immediate breast reconstruction allowed No known BRCA1 and BRCA2 carriers Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified Not pregnant Fit for adjuvant chemotherapy, adjuvant endocrine therapy, and post-operative radiotherapy No prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent trastuzumab No prior neoadjuvant systemic therapy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity. | Radiation: radiation therapy<br>* Chest wall radiotherapy<br>|
| Active Comparator: Arm II<br>Patients receive standard of care and observation only. | Procedure: standard follow-up care<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Acute and late morbidity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest wall recurrence |  |  | 
| Regional recurrence |  |  | 
| Disease-free survival |  |  | 
| Metastasis-free survival |  |  | 
| Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular]) |  |  | 
| Quality of life |  |  | 
| Cost effectiveness |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer