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

NCT ID: NCT00966888

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 3500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

Brief 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.

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Study Groups

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.

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

Chest wall radiotherapy

Arm II

Patients receive standard of care and observation only.

Group Type: ACTIVE_COMPARATOR

standard follow-up care

Intervention Type: PROCEDURE

No intervention

Interventions

standard follow-up care

No intervention

Intervention Type: PROCEDURE

radiation therapy

Chest wall radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ian H. Kunkler, MD

Role: PRINCIPAL_INVESTIGATOR

Edinburgh Cancer Centre at Western General Hospital

Locations

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, United Kingdom

Site Status: RECRUITING

Royal Infirmary - Castle

Glasgow, Scotland, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Ian H. Kunkler, MD

Role: primary

Peter A. Canney, MD

Role: primary

Other Identifiers

CDR0000642751

Identifier Type: REGISTRY

Identifier Source: secondary_id

ISRCTN61145589

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20943

Identifier Type: -

Identifier Source: secondary_id

MRC-BIG2-04

Identifier Type: -

Identifier Source: org_study_id