prevention of chemotherapy induced ovarian failure with goserelin in bc patients (zoro)

Conditions: Breast Cancer

Summary: study done in young breast cancer patients to prevent chemotherapy induced ovarian failure

study design: prospective, randomized, open phase ii trial schedule: all patients will receive an anthracycline-containing polychemotherapy. patients randomized to goserelin will receive their first injection of 3.6 mg at least 2 weeks before start of chemotherapy. goserelin will be given as a subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) until the end of the last chemotherapy cycle. primary objective: •to increase the percentage of patients with normal ovarian function at 6 months after application of (neo)adjuvant, anthracycline-containing polychemotherapy in parallel with goserelin compared to chemotherapy alone. secondary objectives: to compare the two treatment groups regarding * compliance to treatment * toxicity * quality of life * menopausal symptoms score * ovarian function at 6, 12, 18 and 24 months * duration until recovery of regular menstrual period * pregnancy rate

Eligibility criteria:
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

Keywords: hormone insensitive breast cancer prevention of chemotherapy induced ovarian failure p.o.f. gnrh-agonist goserelin