Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments tamoxifen citrate, adjuvant therapy
Phase phase 3
Sponsor University of Oxford
Start date October 1995
Trial size 20000 participants
Trial identifier NCT00003016, ATLAS, CDR0000065596, EU-96064

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.

PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Overall survival (i.e., all-cause mortality)
time frame:

Secondary Outcomes

Measure
Specific-cause mortality
time frame:
Incidence of second primary tumors
time frame:

Eligibility Criteria

Male or female participants of any age.

DISEASE CHARACTERISTICS: - Curatively treated carcinoma of the breast - Currently taking adjuvant tamoxifen - Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen) PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - No contraindications to receiving tamoxifen - No other serious medical problems PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy allowed Chemotherapy: - Prior chemotherapy allowed Endocrine therapy: - See Disease Characteristics Radiotherapy: - Prior radiotherapy allowed Surgery: - Prior surgery allowed

Additional Information

Official title Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study
Description OBJECTIVES: - Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen. OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years. Patients are followed annually. PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).