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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 - REP0114

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

What is the purpose of this study?

This is a phase II study 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 RECIST criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occurs first) in patients with metastatic TNBC treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone.

fRida Trial - Discover the Infographic

Trial overview

Condition

Metastatic Triple Negative Breast Cancer (TNBC)

Study Identifiers

NCT02370238

Study type

Interventional

Intervention

Drug: Paclitaxel
Drug: Reparixin
Drug: Placebo

Phase

II

Start date

Jun 2015

End Date

Feb2018

Enrollment Goal

156 patients

Going deep into the trial

Eligibility/Recruitment

Age

≥ 18 years old

Gender

Accepts healthy volunteers

Key Criteria

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Inclusion

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Exclusion

Some information about patients involvement

Study participation will last approximately 4-8 months. There are weekly visits to the doctor during the treatment period. Orally administered reparixin or placebo will be taken daily for 21 days of each 28-day treatment cycle. Paclitaxel (chemotherapy) will be given intravenously on days 1, 8, and 15 of each 28-day treatment cycle.

Desired Outcomes

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Primary Outcomes

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Secondary Outcomes

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Exploratory Outcomes

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