Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study
N/A
N/A
Both
Breast Cancer
Trial Information
Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival (i.e., all-cause mortality)
Safety Issue:
No
Principal Investigator
Rodrigo Arriagada, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Karolinska Institutet
Authority:
United States: Federal Government
Study ID:
CDR0000065596
NCT ID:
NCT00003016
Start Date:
October 1995
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
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