Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
62
Universitätsfrauenklinik, Rostock Universität
Rostock, Mecklenburg-Vorpommern, Germany
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
Discontinuation, delay, or dose-reductions of chemotherapy
Time frame: December 2008
Discontinuation or delay of Goserelin injections
Time frame: December 2008
Any grade II to grade IV AE specified to serious or non serious events during treatment with chemotherapy +/- Goserelin
Time frame: December 2008
Evaluation according to EORTC Q 30
Time frame: March 2010
According to menopausal symptom score: E2, FSH, LH, SHGB, and Progesterone at 0, 6, 12, 18 and 24 months
Time frame: March 2010
Date of first regular menstrual period
Time frame: March 2010
Any diagnosis of pregnancy during study follow up
Time frame: March 2010
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