A randomized, 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).

ABSTRACT:

Purpose

CXCR1, one of the receptors for CXCL8, has been identified as a druggable target on breast cancer cancer stem cells (CSC). Reparixin (R), an investigational oral inhibitor of CXCR1, was safely administered to metastatic breast cancer patients in combination with paclitaxel (P) and appeared to reduce CSC in a window-of-opportunity trial in operable breast cancer. The fRida trial (NCT02370238) evaluated the addition of R to weekly as first-line therapy for metastatic (m) TNBC.

Subjects and methods

Subjects with untreated mTNBC were randomized 1:1 to R or placebo days 1-21 in combination with weekly P 80 mg/m² on days 1, 8, 15 of 28-day cycles. The primary endpoint was PFS by central review.

Results

123 subjects were randomized (62 to R + P and 61 to p

SUBMITTER: Goldstein LJ 

PROVIDER: S-EPMC8558154 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature