Triptorelin 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
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.
|Breast Cancer||Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil Drug: methotrexate Drug: paclitaxel Drug: triptorelin Procedure: adjuvant therapy||Phase 3|
|Study Design:||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||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]|
- 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
|Study Start Date:||September 2003|
|Study Completion Date:||April 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
- 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 alone.
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 chemotherapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311636
|Castelfranco - TV, Italy, 31033|
|Ospedale Sant Anna|
|Como, Italy, 22100|
|Ospedale Santa Croce|
|Cuneo, Italy, 12100|
|Azienda Ospedaliera di Firenze|
|Florence, Italy, 50011|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Presidio Ospedaliero di Livorno|
|Livorno, Italy, 57100|
|Carlo Poma Hospital|
|Mantova, Italy, 46100|
|Federico II University Medical School|
|Naples, Italy, 80131|
|Seconda Universita di Napoli|
|Naples, Italy, 80131|
|Istituto G. Pascale|
|Naples, Italy, 81131|
|Perugia, Italy, 06156|
|Ospedale Santa Chiara Pisa|
|Pisa, Italy, 56126|
|Istituto Regina Elena|
|Rome, Italy, 00128|
|Ospedale Civile ASL 1|
|Sassari, Italy, 07100|
|Ospedale SS Trinita|
|Sora, Italy, 03039|
|Ospedale Treviglio Caravaggio|
|Treviglio, Italy, 24047|
|Ospedale Maggiore dell' Universita|
|Trieste, Italy, 34100|
|Universita di Torino|
|Turin, Italy, 10126|
|Study Chair:||Lucia Del Mastro, MD||IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy|