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

August 9, 2013 updated by: Medical Research Council

Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

3500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Recruiting
        • Edinburgh Cancer Centre at Western General Hospital
        • Contact:
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • Recruiting
        • Royal Infirmary - Castle
        • Contact:
          • Peter A. Canney, MD
          • Phone Number: 44-141-211-1160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Acute and late morbidity

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

  • Principal Investigator: Ian H. Kunkler, MD, Edinburgh Cancer Centre at Western General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-BIG2-04
  • CDR0000642751 (Registry Identifier: PDQ (Physician Data Query))
  • ISRCTN61145589 (Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register))
  • EU-20943

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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