TRial on the Endocrine Activity of Neoadjuvant Degarelix

Summary

The purpose of the this study is to investigate the anti-tumor activity and tolerability of the study medications Degarelix and Triptorelin in premenopausal women receiving preoperative treatment with Letrozole.

Timeline

Start

2014-02

Primary completion

2017-08-25

Completion

2017-08-25

Outcome

Met primary endpoint

paper Time to optimal OFS was three times faster for patients assigned to degarelix and letrozole than to triptorelin and letrozole PMID 30589600 ↗

paper median, 3 v 14 days; hazard ratio, 3.05; 95% CI, 1.65 to 5.65; P < .001 PMID 30589600 ↗

Publications

• Background Kaufmann M, von Minckwitz G, Mamounas EP, Cameron D, Carey LA, Cristofanilli M, Denkert C, Eiermann W, Gnant M, Harris JR, Karn T, Liedtke C, Mauri D, Rouzier R, Ruckhaeberle E, Semiglazov V, Symmans WF, Tutt A, Pusztai L. Recommendations from an international consensus conference on the current status and future of neoadjuvant systemic therapy in primary breast cancer. Ann Surg Oncol. 2012 May;19(5):1508-16. doi: 10.1245/s10434-011-2108-2. Epub 2011 Dec 23.
• Background Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.
• Background Guarneri V, Broglio K, Kau SW, Cristofanilli M, Buzdar AU, Valero V, Buchholz T, Meric F, Middleton L, Hortobagyi GN, Gonzalez-Angulo AM. Prognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factors. J Clin Oncol. 2006 Mar 1;24(7):1037-44. doi: 10.1200/JCO.2005.02.6914.
• Background Kuerer HM, Newman LA, Smith TL, Ames FC, Hunt KK, Dhingra K, Theriault RL, Singh G, Binkley SM, Sneige N, Buchholz TA, Ross MI, McNeese MD, Buzdar AU, Hortobagyi GN, Singletary SE. Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol. 1999 Feb;17(2):460-9. doi: 10.1200/JCO.1999.17.2.460.
• Dellapasqua S, Gray KP, Munzone E, Rubino D, Gianni L, Johansson H, Viale G, Ribi K, Bernhard J, Kammler R, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Regan MM, Goldhirsch A, Colleoni M; International Breast Cancer Study Group. Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Who Receive Letrozole for Locally Advanced Endocrine-Responsive Breast Cancer: A Randomized Phase II Trial. J Clin Oncol. 2019 Feb 10;37(5):386-395. doi: 10.1200/JCO.18.00296. Epub 2018 Dec 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Degarelix	Other / unclassified	80 mg	Subcutaneous
Subject	Triptorelin	Other / unclassified	3.75 mg	Intramuscular
Background	Letrozole	Other / unclassified	2.5 mg	Oral

Indications