Overview
Tamoxifen in Treating Women With Breast Cancer
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital BirminghamTreatments:
Tamoxifen
Criteria
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