Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy.

Entry Criteria

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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No concurrent trastuzumab
• No prior neoadjuvant systemic therapy

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

Expected Enrollment

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council

Ian Kunkler, MD, Principal investigator		Ph: 44-131-537-2214 Email: i.kunkler@ed.ac.uk

United Kingdom
Scotland
	Edinburgh
	Edinburgh Cancer Centre at Western General Hospital
		Ian Kunkler, MD	Ph:  44-131-537-2214
			Email: i.kunkler@ed.ac.uk
	Glasgow
	Royal Infirmary - Castle
		Peter Canney, MD	Ph:  44-141-211-1160

Registry Information
Official Title		Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO
Trial Start Date		2006-01-24
Trial Completion Date		2010-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00966888
Date Submitted to PDQ		2009-05-08
Information Last Verified		2009-08-25

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