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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- German Breast Group
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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
Investigators
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
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
Outcomes
Primary Outcomes
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
Time Frame: December 2008
Secondary Outcomes
- Discontinuation or delay of Goserelin injections(December 2008)
- Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin(December 2008)
- Discontinuation, delay, or dose-reductions of chemotherapy(December 2008)
- Evaluation according to EORTC Q 30(March 2010)
- According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months(March 2010)
- Date of first regular menstrual period(March 2010)
- Any diagnosis of pregnancy during study follow up(March 2010)