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

GBG Forschungs GmbH0 sites62 target enrollmentMay 3, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: -young hormone insensitive breast cancer patients receiving anthracycline containing (neo-)adjuvant chemotherapy
Sponsor: GBG Forschungs GmbH
Enrollment: 62
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

May 3, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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;

•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;