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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00966888
First received: August 26, 2009
Last updated: August 9, 2013
Last verified: August 2009
  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.


Condition Intervention Phase
Breast Cancer
Procedure: standard follow-up care
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Acute and late morbidity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chest wall recurrence [ Designated as safety issue: No ]
  • Regional recurrence [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Metastasis-free survival [ Designated as safety issue: No ]
  • Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular]) [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Cost effectiveness [ Designated as safety issue: No ]

Estimated Enrollment: 3500
Study Start Date: January 2006
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966888

Locations
United Kingdom
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Ian H. Kunkler, MD    44-131-537-2214    i.kunkler@ed.ac.uk   
Royal Infirmary - Castle Recruiting
Glasgow, Scotland, United Kingdom, G4 0SF
Contact: Peter A. Canney, MD    44-141-211-1160      
Sponsors and Collaborators
Medical Research Council
Investigators
Principal Investigator: Ian H. Kunkler, MD Edinburgh Cancer Centre at Western General Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00966888     History of Changes
Other Study ID Numbers: MRC-BIG2-04, CDR0000642751, ISRCTN61145589, EU-20943
Study First Received: August 26, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014