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

Breast Cancer Clinical Trial

Official title:

Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00966888
• Other study ID #: MRC-BIG2-04
• Secondary ID: CDR0000642751ISR
• Status: Recruiting
• Phase: Phase 3
• First received: August 26, 2009
• Last updated: August 9, 2013
• Start date: January 2006

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• standard follow-up care
No intervention

Radiation:
• radiation therapy
Chest wall radiotherapy

Locations

Country	Name	City	State
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Primary	Acute and late morbidity			No
Secondary	Chest wall recurrence			No
Secondary	Regional recurrence			No
Secondary	Disease-free survival			No
Secondary	Metastasis-free survival			No
Secondary	Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])			No
Secondary	Quality of life			No
Secondary	Cost effectiveness			No