S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; International Breast Cancer Study Group; National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Goserelin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Stage I-IIIA

• Operable disease

• Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative

• Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:

• 3-month/4-course anthracycline-based regimen

• 6- to 8-month/course anthracycline-based regimen

• 6- to 8-month/course non-anthracycline-based regimen

• Hormone receptor status:

• Estrogen receptor negative

• Progesterone receptor negative

PATIENT CHARACTERISTICS:

Age

• 18 to 49

Sex

• Female

Menopausal status

• Premenopausal

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing

• Fertile patients must use effective barrier contraception

• No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior cytotoxic chemotherapy

Endocrine therapy

• No other concurrent hormonal therapy

Radiotherapy

• Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed

Surgery

• See Disease Characteristics

Other

• Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed