Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer
- To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses.
- To determine the incidence of pregnancy and the effect for participants' quality of life (QOL) after chemotherapy.
- To determine the overall survival and disease-free survival times of study participants.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Study of a Goserelin Acetate for Preservation of Ovarian Function in Patients With Primary Breast Cancer (PBC)|
- Number of Patients With Response (FSH Level + Vaginal Bleeding) [ Time Frame: Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2006|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
Other Name: Zoladex
|No Intervention: No Goserelin|
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 group.
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 dose.
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.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|St. Luke's International Hospital|
|Principal Investigator:||Naoto Ueno, MD, PhD||M.D. Anderson Cancer Center|