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
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
Interventional
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
December 2008
No
Bernd Gerber, MD
Principal Investigator
Rostock Universität, Universitätsfrauenklinik
Germany: Federal Institute for Drugs and Medical Devices
GBG37
NCT00196846
March 2005
March 2010
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