At a glance
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A Randomized Phase II Trial Evaluating the Endocrine Activity and Efficacy of Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Receiving Letrozole for Primary Endocrine Responsive Breast Cancer
In Brief
A Phase 2 clinical trial evaluating triptorelin, degarelix, and 1 other intervention for Breast Cancer Invasive Nos. Completed, enrolled 51 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole 2.5 mg orally every day for 6 cycles