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
Prospective, randomized, open phase II trial
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.
•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.
To compare the two treatment groups regarding
- Compliance to treatment
- Quality of life
- Menopausal Symptoms Score
- Ovarian function at 6, 12, 18 and 24 months
- Duration until recovery of regular menstrual period
- Pregnancy rate
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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
Bernd Gerber, MD
Rostock Universität, Universitätsfrauenklinik
Germany: Federal Institute for Drugs and Medical Devices