This trial is active, not recruiting.

Condition breast cancer
Treatments tamoxifen citrate, adjuvant therapy
Phase phase 3
Sponsor University Hospital Birmingham
Start date May 1991
Trial size 20000 participants
Trial identifier NCT00003678, CDR0000066779, CRC-TU-ATTOM, EU-98042, ISRCTN17222211


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

All-cause mortality
time frame:

Secondary Outcomes

Disease recurrence
time frame:
Death due to breast cancer, other primary tumors, or cardiovascular causes
time frame:

Eligibility Criteria

Female participants of any age.

DISEASE CHARACTERISTICS: - Histologically confirmed breast carcinoma that has been completely excised - Clinically relapse free - Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen - No significant endometrial hyperplasia - No patients with negligibly low risk of breast cancer death - Hormone receptor status: - Any status allowed PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Any status allowed Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other life threatening disease - No retinopathy - No psychiatric disorder or other condition that would preclude study compliance - No serious toxicity (e.g., depression) thought to be due to tamoxifen - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - See Disease Characteristics Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - Any primary treatment allowed

Additional Information

Official title A Large, Uniquely Simple, Randomised Study to Assess Much More Reliably the Balance of Benefits and Risks of Prolonging Adjuvant Tamoxifen Treatment in Early Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).