EUCTR2004-003980-62-DEActive, not recruitingNot Applicable
Prospective randomized multicenter study to prevent chemotherapy induced ovarian failure with the GnRH-Agonist Goserelin in young hormone insensitive breast cancer patients receiving anthracycline containing (neo-)adjuvant chemotherapy (GBG 37) - Zoro
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GBG Forschungs GmbH
- Enrollment
- 62
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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 regulary 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-proceedures);
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 concommittant 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;
Investigators
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