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: -young hormone insensitive breast cancer patients receiving anthracycline containing (neo-)adjuvant chemotherapy

• Registration Number: EUCTR2004-003980-62-DE
• Lead Sponsor: GBG Forschungs GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 62

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To increase the percentage of patients with normal ovarian function at 6 months after applicaton of (neo)adjuvant, anthracycline-containing polychemotherapy in parallel with Goserelin compared to chemotherapy alone.;Primary end point(s): Normal ovarian function as defined by two consecutive menstrual periods within 21-35 days within a time frame of 5 - 8 months after last application of goserelin;Secondary Objective: To compare the two treatment groups regarding<br>•Compliance to treatment<br>•Toxicity <br>•Quality of life<br>•Menopausal Symptoms Score<br>•Ovarian function at 6, 12, 18 and 24 months<br>•Duration until recovery of regular menstrual period<br>•Determination of the ovarian reserve by vaginal ultrasound and blood hormone measurements for FSH, Estradiol, Anti-Mullerian Hormone (AMH) and Inhibin B after End of Chemotherapy (EOC)/End of Goserelin treatment (EOGT) at one point of time during follow-up<br>•Pregnancy rate<br><br>