Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.

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

Details

• Lead Sponsor: Anglo Celtic Cooperative Oncology Group
• Treatments: Cyclophosphamide; Estrogens; Goserelin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Stages I-IIIB with node-positive or -negative disease (N0-2)

• Operable disease

• Must meet 1 of the following criteria:

• Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks

• Scheduled to receive neoadjuvant chemotherapy

• No metastatic breast cancer, including supraclavicular fossa metastases

• Hormone receptor status meeting 1 of the following criteria:

• Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy

• ER positive AND no requirement for ovarian suppression as a necessary part of treatment

PATIENT CHARACTERISTICS:

• Female

• Premenopausal with regular menses in the 12 months preceding surgery

• No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• Suitable fitness status for chemotherapy

• Adequate hepatic, renal, and bone marrow function

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy or endocrine therapy