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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. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966888
First Posted: August 27, 2009
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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
  • Acute and late morbidity

Secondary Outcome Measures:
  • 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00966888     History of Changes
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
First Submitted: August 26, 2009
First Posted: August 27, 2009
Last Update Posted: August 12, 2013
Last Verified: August 2009

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