Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | Any age | Other | ATLAS EU-96064, NCT00003016 |
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.
Entry 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)
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
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
Expected Enrollment
20000Approximately 20,000 patients will be accrued for this study.
Outcomes
Primary Outcome(s)Overall survival (i.e., all-cause mortality)
Specific-cause mortality
Incidence of second primary tumors
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.
Trial Lead Organizations
Atlas Trial Office
 | | | ||
| Rodrigo Arriagada, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study | |
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| Trial Start Date | 1995-10-01 | |
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| Registered in ClinicalTrials.gov | NCT00003016 | |
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| Date Submitted to PDQ | 1997-08-18 | |
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| Information Last Verified | 2002-10-23 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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