NCT00002720

Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer

QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 642 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.

Detailed description

OBJECTIVES: * Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer. * Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes. * Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years. Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	tamoxifen citrate
PROCEDURE	conventional surgery

Timeline

• Start date: 1995-12-01
• Completion: 2012-12-01
• First posted: 2003-01-27
• Last updated: 2013-09-20

Locations

1 site across 1 country: Italy