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

NCT ID: NCT00196846

Last Updated: 2010-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2010-03-31

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 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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Goserelin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GBG Forschungs GmbH

OTHER

Sponsor Role: lead

Responsible Party

GBG

Principal Investigators

Bernd Gerber, MD

Role: PRINCIPAL_INVESTIGATOR

Rostock Universität, Universitätsfrauenklinik

Locations

Universitätsfrauenklinik, Rostock Universität

Rostock, Mecklenburg-Vorpommern, Germany

Countries

Germany

Related Links

http://www.germanbreastgroup.de

Click here for more information about this study: ZORO Study

Other Identifiers

Eudract Number: 2004-003980-62

Identifier Type: -

Identifier Source: secondary_id

GBG37

Identifier Type: -

Identifier Source: org_study_id