S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Condition: Breast Cancer; Infertility; Menopausal Symptoms
MeSH terms: Breast Neoplasms; Infertility
Intervention: cyclophosphamide; goserelin acetate
Intervention description: Part of planned chemotherapy regimen; Given subcutaneously
Intervention MeSH terms: Cyclophosphamide; Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 257.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: infertility; menopausal symptoms; stage II breast cancer; stage IIIA breast cancer; stage IA breast cancer; stage IB breast cancer; estrogen receptor-negative breast cancer; progesterone receptor-negative breast cancer

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.
    

Eligibility 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