Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer

Phase 3

• Conditions: Breast Cancer

• Registration Number: NCT00006030
• Lead Sponsor: British Association of Surgical Oncology: Breast Group

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation therapy and tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen is most effective for stage I breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer.

Detailed Description

OBJECTIVES: I. Compare the effectiveness of wide local excision alone versus wide local excision followed by radiotherapy with or without tamoxifen versus wide local excision plus tamoxifen in women with stage I breast cancer. II. Assess local occurrence in the treated breast, regional recurrence, distant recurrence, death from breast cancer, and occurrence of cancer in the opposite breast in these patients when treated with one of these regimens.

OUTLINE: This is a randomized study. Patients are randomized to one of four treatment arms. All patients undergo wide local excision of the tumor and axillary node dissection. Arm I: Patients undergo surgery only. Arm II: Patients undergo surgery followed by 25-35 radiotherapy treatments. Arm III: Patients undergo surgery plus oral tamoxifen daily for 5 years. Arm IV: Patients undergo surgery followed by 25-35 radiotherapy treatments and oral tamoxifen daily for five years. Patients are followed every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 1200 patients (300 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 1992-01
• Study First Submitted: 2000-07-05
• Study First Submitted QC: 2004-03-24
• Study First Posted: 2004-03-25
• Status Verified: 2006-12
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Nottingham City Hospital NHS Trust; 🇬🇧 Nottingham, England, United Kingdom