Status:
COMPLETED
Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)
Lead Sponsor:
GBG Forschungs GmbH
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure
Detailed Description
Study Design: Prospective, randomized, open phase II trial Schedule: All patients will receive an anthracycline-containing polychemotherapy. Patients randomized to Goserelin will receive their fir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00196846
Start Date
March 1 2005
End Date
March 1 2010
Last Update
June 14 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsfrauenklinik, Rostock Universität
Rostock, Mecklenburg-Vorpommern, Germany, 18075