Tamoxifen in Treating Women With Breast Cancer

Phase 3

• Conditions: Breast Cancer

• Registration Number: NCT00003678
• Lead Sponsor: University Hospital Birmingham

Brief Summary

RATIONALE: 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.

PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.

Detailed Description

OBJECTIVES:

* Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.

OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.

* Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.

Patients are followed annually.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.

Study Timeline

• Study Start: 1991-05
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-03
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality

Secondary Outcome Measures

Name	Time	Method
Disease recurrence
Death due to breast cancer, other primary tumors, or cardiovascular causes

Trial Locations

Locations (1)

Cancer Research UK Clinical Trials Unit - Birmingham; 🇬🇧 Birmingham, England, United Kingdom