Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)

Inclusion Criteria: Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures Complete baseline documentation sent to GBG Age of at least 18 and at most 45 years Patients request to preserve ovarian function Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy Steroid receptor (estrogen and progesterone) negative tumor (diagnosis according to hospital standard-procedures) No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated Karnofsky-Index >80% Life expectancy of at least 10 years, disregarding the diagnosis of cancer Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center. Exclusion Criteria: Known hypersensitivity reaction to the investigational compounds or incorporated substances Prior cytotoxic treatment for any reason Suspected (primary or secondary) ovarian insufficiency Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) Concurrent treatment with other experimental drugs or any other anti-cancer therapy Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry