Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)
Goserelin is designed to block hormones that can regulate your menstruation by affecting the
pituitary gland (part of brain).
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of two treatment groups. You will either be assigned to
receive goserelin or no treatment. There is an equal chance of being assigned to either
If you are assigned to receive goserelin, the first dose will be given as an injection under
the skin, 1 week before you start chemotherapy. You will then receive chemotherapy as part
of your standard of care. Following the first dose of goserelin, you will be given a
goserelin injection into the skin, once a month until 3 weeks after the last chemotherapy
You will be taken off study if intolerable side effects occur during this study. After you
are finished with chemotherapy, you will have a series of follow-up visits. During the
period of follow-up, you will have a medical history, physical exam, and blood tests (2-3
teaspoons) to evaluate your ovarian function, every 3 months for 1 year and then at 24
months. You will be asked to fill out questionnaires about your menstrual history at these
visits. The questionnaires should take about 15 minutes to complete. You will be also
asked to fill out questionnaires about your quality of life at 12 and 24 months. The
questionnaires should take about 30 minutes to complete.
This is an investigational study. Goserelin is commercially available and has been approved
by the FDA for use in breast cancer patients. Its use in this study is investigational.
About 148 patients will take part in this multicenter study. Up to 36 patients will be
enrolled at M.D. Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Response (FSH Level + Vaginal Bleeding)
Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, "response" defined as a composite event: both [FSH < 15] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.
Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year
Naoto Ueno, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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