drugset / Trial / NCT00311636
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
RandomizedOpen-labelSupportive care
Summary
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.
Timeline
- Start
- 2003-09
- Primary completion
- 2008-01
- Completion
- 2008-04
Outcome
Met primary endpoint
paper The use of triptorelin-induced temporary ovarian suppression during chemotherapy in premenopausal patients with early-stage breast cancer reduced the occurrence of chemotherapy-induced early menopause. PMID 21771987 ↗
paper absolute difference of -17% (95% confidence interval, -26% to -7.9%; P < .001). PMID 21771987 ↗
Publications
- Results Del Mastro L, Boni L, Michelotti A, Gamucci T, Olmeo N, Gori S, Giordano M, Garrone O, Pronzato P, Bighin C, Levaggi A, Giraudi S, Cresti N, Magnolfi E, Scotto T, Vecchio C, Venturini M. Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: a randomized trial. JAMA. 2011 Jul 20;306(3):269-76. doi: 10.1001/jama.2011.991.
- Lambertini M, Boni L, Michelotti A, Gamucci T, Scotto T, Gori S, Giordano M, Garrone O, Levaggi A, Poggio F, Giraudi S, Bighin C, Vecchio C, Sertoli MR, Pronzato P, Del Mastro L; GIM Study Group. Ovarian Suppression With Triptorelin During Adjuvant Breast Cancer Chemotherapy and Long-term Ovarian Function, Pregnancies, and Disease-Free Survival: A Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2632-40. doi: 10.1001/jama.2015.17291.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triptorelin | Other / unclassified | 3.75 mg | Intramuscular |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Epirubicin | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |