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

NCT00966888 | Unknown Phase 3

• 4 other identifiers: MRC-BIG2-04CDR0000642751ISRCTN61145589EU-20943
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer

Outcome Measures

Primary Outcomes (2)

• Overall survival

• Acute and late morbidity

Secondary Outcomes (7)

• Chest wall recurrence

• Regional recurrence

• Disease-free survival

• Metastasis-free survival

• Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

ACTIVE COMPARATOR

Patients receive standard of care and observation only.

Procedure: standard follow-up care

Interventions

standard follow-up care PROCEDURE

No intervention

Arm II

radiation therapy RADIATION

Chest wall radiotherapy

Arm I

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (2)

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

RECRUITING

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ian H. Kunkler, MD

  Edinburgh Cancer Centre at Western General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: January 1, 2006
• Primary Completion: June 1, 2010
• Last Updated: August 12, 2013

Record last verified: 2009-08

Locations

GB (2)