At a glance
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A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)
In Brief
A Phase 2 clinical trial evaluating paclitaxel, Reparixin, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 194 participants across 77 sites in 7 countries.
Detailed Summary
The Objectives of this study: The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone. The secondary objectives were: * To determine overall survival (OS). * To evaluate objective response rates (ORR). * To determine median PFS (mPFS). * To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).
Study Details
Timeline
Interventions
paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15)
reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle
placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle