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

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