Clinical Trials /

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

NCT00966888

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy
  • Official Title: Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

Clinical Trial IDs

  • ORG STUDY ID: MRC-BIG2-04
  • SECONDARY ID: CDR0000642751
  • SECONDARY ID: ISRCTN61145589
  • SECONDARY ID: EU-20943
  • NCT ID: NCT00966888

Conditions

  • Breast Cancer

Purpose

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

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm IExperimentalBeginning 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 IIActive ComparatorPatients receive standard of care and observation only.

      Eligibility 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
      
              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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:N/A
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Overall survival
      Time Frame:
      Safety Issue:
      Description:

      Secondary Outcome Measures

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

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Unknown status
      Lead Sponsor:Medical Research Council

      Trial Keywords

      • stage II breast cancer

      Last Updated

      August 9, 2013