Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | Any age | Other | CDR0000065596 ATLAS, EU-96064, NCT00003016 |
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.
Further Study Information
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.
Eligibility Criteria
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
Trial Lead Organizations/Sponsors
Oxford Radcliffe Hospital
| Rodrigo Arriagada, MD |  | Study Chair |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003016
Information obtained from ClinicalTrials.gov on April 01, 2013
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