Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy
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|ClinicalTrials.gov Identifier: NCT00966888|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 27, 2009
Last Update Posted : August 12, 2013
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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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: standard follow-up care Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3500 participants|
|Official Title:||Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||June 2010|
Experimental: 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.
Radiation: radiation therapy
Chest wall radiotherapy
Active Comparator: Arm II
Patients receive standard of care and observation only.
Procedure: standard follow-up care
- Overall survival
- Acute and late morbidity
- 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
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966888
|Edinburgh Cancer Centre at Western General Hospital||Recruiting|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Contact: Ian H. Kunkler, MD 44-131-537-2214 email@example.com|
|Royal Infirmary - Castle||Recruiting|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Contact: Peter A. Canney, MD 44-141-211-1160|
|Principal Investigator:||Ian H. Kunkler, MD||Edinburgh Cancer Centre at Western General Hospital|
|Other Study ID Numbers:||
CDR0000642751 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN61145589 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
|First Posted:||August 27, 2009 Key Record Dates|
|Last Update Posted:||August 12, 2013|
|Last Verified:||August 2009|
stage II breast cancer
Neoplasms by Site