A Phase 3 interventional study of cyclophosphamide and docetaxel in Breast Cancer, sponsored by Gruppo Italiano Mammella (GIM). Completed at 18 sites in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-06-26.
Sponsored by Gruppo Italiano Mammella (GIM) · Phase 3, Interventional, and Supportive care
RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening.
PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.
Patients with hormone-sensitive tumors who resume ovarian function after stopping chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2 years.
Patients undergo menopausal status assessment, using follicle-stimulating hormone, luteinizing hormone, and estradiol as biochemical markers, at baseline and 3, 6, 9, and 12 months after the last course of chemotherapy.
After completion of study treatment, patients are followed at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 280 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Gruppo Italiano Mammella (GIM) is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer resected at time of original diagnosis
Candidate for 1 of the following adjuvant chemotherapy regimens:
No evidence of metastases or localized or distant recurrence
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy
Toxicity as measured by Common Toxicity Criteria at each chemotherapy course
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Gruppo Italiano Mammella (GIM)