Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Goserelin
Intervention description: 3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
Intervention MeSH terms: Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 15 Years
Maximum age: 46 Years
Healthy volunteers: No
Keywords: Breast Cancer; Chemotherapy; Ovarian Function; Goserelin; Zoladex; Ovary function; Fertility; Early Menopause

Summary:

      Primary Objective:

        -  To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian
           function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for
           primary invasive breast cancer by documenting persistence or resumption of regular
           menses.

      Secondary Objectives:

        -  To determine the incidence of pregnancy and the effect for participants' quality of life
           (QOL) after chemotherapy.

        -  To determine the overall survival and disease-free survival times of study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female patients older than 15 years and younger than 46 years.

          2. Primary breast cancer (Stage I, II, or III).

          3. Pathologically confirmed invasive breast carcinoma.

          4. Negative hormone-receptor status. (Negative defined as ER- and PR- staining in less
             than 10% of tumor cells, or tumors with less than or equal to 3 fm/mg cytosol protein
             on ligand-binding or enzyme-linked immunoassay).

          5. Premenopausal, verified before chemotherapy is begun as satisfying both:

               -  Cyclic vaginal bleeding.

               -  Follicle-stimulating hormone (FSH) is less than or equal to 15 IU/L. If patients
                  are taking oral contraceptives, FSH must be measured 1-2 weeks after
                  discontinuation. If FSH is greater than 15 and the patient has regular menses,
                  gynecologic consultation will be required for a decision on premenopausal status.

          6. Candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.

          7. Treatment with at least four (4) cycles of chemotherapy as planned.

          8. Zubrod performance score of 0 or 1.

          9. Must consent to preservation of their ovarian function and indicate their awareness of
             the investigational nature of this study, in keeping with institutional policy.

         10. Willingness to use barrier contraception if sexually active.

        Exclusion Criteria:

          1. Pregnancy. Women must have a negative serum pregnancy test before initiation of
             injection.

          2. Hypersensitivity to any GnRH analog.

          3. Previous receipt of systemic chemotherapy.

          4. To receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with CMF.

          5. Stage IV breast cancer.

          6. Prothrombin time (PT) and partial prothrombin time (PTT) with INR > 1.5

          7. Platelets < 50,000/mm^3