Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: 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.

PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK
• Treatments: Goserelin; Tamoxifen

Criteria

DISEASE CHARACTERISTICS: Operable, clinical Stage I/II breast cancer (T1-3, N0-1, M0) No evidence of distant metastases on x-ray of chest, spine, and pelvis Bone scan evidence alone of secondary mass allowed unless considered unequivocal evidence of metastasis No primary carcinoma fixed to underlying muscle or chest wall No deeply fixed axillary nodes No ulceration, skin infiltration, or peau d'orange involving more than 1/3 of breast No bilateral tumors Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Under 50 Sex: Women only Menopausal status: Any status Performance status: Not specified Life expectancy: No limits on life expectancy due to intercurrent illness Hematopoietic: WBC at least 3,000 Platelets at least 90,000 Hemoglobin at least 10 g/dL Hepatic: Normal liver function required Renal: Normal kidney function required Other: Fit for surgery No prior treatment for other malignancies except: Nonmelanomatous skin cancer Cone-biopsied in situ carcinoma of the cervix English-speaking patients eligible for quality-of-life assessments

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Chemotherapy for high-risk patients allowed at the discretion of the clinician Endocrine therapy: At least 6 weeks since prior hormonal therapy No concomitant hormonal therapy including oral contraceptives (patients must discontinue the pill for 2 years) Radiotherapy: Not specified Surgery: Not specified