A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer
Status:
Completed
Trial end date:
2020-03-23
Target enrollment:
Participant gender:
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).