Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE]
- Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women
undergoing adjuvant chemotherapy in combination with vs without triptorelin for
previously resected stage I-III breast cancer.
- Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy
OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I (adjuvant chemotherapy alone): Patients receive adjuvant chemotherapy alone.
- Arm II (adjuvant chemotherapy and triptorelin): Patients receive adjuvant chemotherapy
and triptorelin intramuscularly 1 week before and then every 4 weeks for the duration
of chemotherapy. The last dose of triptorelin is given before the last course of
Patients with hormone-sensitive tumors who resume ovarian function after stopping
chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
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
Lucia Del Mastro, MD
National Institute for Cancer Research, Italy
United States: Federal Government