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 localregulatory 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/mlin follicular phase

• Histologically confirmed primary breast cancer with the need for anthracycline-basedchemotherapy

• Steroid receptor (estrogen and progesterone) negative tumor (diagnosis according tohospital standard-procedures)

• No clinical evidence of local recurrence or distant metastases. Complete stagingwork-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 clinicallyindicated

• 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, serumcreatinine, bilirubin, and transaminases within normal range of the institution

• Patients must be available for and compliant to treatment and follow-up. Patientsregistered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

• Known hypersensitivity reaction to the investigational compounds or incorporatedsubstances

• Prior cytotoxic treatment for any reason

• Suspected (primary or secondary) ovarian insufficiency

• Pregnant or lactating patients. Patients of childbearing potential must have anegative pregnancy test (urine or serum) within 14 days prior to registration and mustimplement adequate non-hormonal contraceptive measures during study treatment; prioruse of hormonal contraceptives has to be discontinued before first Goserelin injection

• Other serious illness or medical condition that may interfere with the understandingand giving of informed consent and the conduct of the study

• Prior or concomitant secondary malignancy (except non-melanomatous skin cancer orcarcinoma 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 studyentry