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Clinical trialNCT02370238CompletedPhase 2Interventional

A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer

SponsorDompé Farmaceutici S.p.AEnrollment194Metastatic Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

77 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • Algemeen Ziekenhuis Klina

    Brasschaat, Belgium

  • Cliniques Universitaires Saint- Luc Ucl

    Brussels, Belgium

  • Universitair Ziekenhuis Antwerpen

    Edegem, Belgium

  • Chu Ambroise Paré

    Mons, Belgium

  • Az St Elisabeth

    Namur, Belgium

Czechia
  • Masaryk Memorial Cancer Institute

    Brno, Czechia

  • Nemocnice Horovice A.S.

    Hořovice, Czechia

  • Fakultni Nemocnice Hradec Králové

    Hradec Králové, Czechia

  • Fakultní Nemocnice Královské Vinohrady

    Prague, Czechia

  • Fakultní Nemocnice V Motole, Onkologická Klinika 2. Lf Uk A Fn Motol

    Prague, Czechia

  • Onkologická Klinika Vfn A 1.Lf Uk

    Prague, Czechia

  • Krajská Nemocnice T.Bati, A. S.

    Zlín, Czechia

France
  • Centre Paul Papin

    Angers, France

  • Centre François Baclesse

    Caen, France

  • Centre Hospitalier de Saint-Brieuc, Yves Le Foll

    La Roche-sur-Yon, France

  • Centre Hospitalier Universitaire (chu) de Limoges - Hopital Dupuytren

    Limoges, France

  • Institut Paoli Calmettes

    Marseille, France

  • Centre Antoine Lacassagne

    Nice, France

  • Hôpital Européen Georges Pompidou

    Paris, France

  • Medicale Centre René Gauducheau

    Saint-Herblain, France

Italy
  • Ospedale "di Summa-Perrino"

    Brindisi, Italy

  • Azienda Ospedaliero-Universitaria

    Cagliari, Italy

  • Azienda Ospedaliero - Universitaria, Policlinico Vittorio Emanuele

    Catania, Italy

  • Istituto Scientifico Romagnolo Per Lo Studio E la Cura Dei Tumori

    Meldola, Italy

  • Ospedale Dell'Angelo

    Mestre, Italy

  • Azienda Ospedaliera, Ospedale San Carlo Borromeo

    Milan, Italy

  • Istituto Europeo Di Oncologia

    Milan, Italy

  • Fondazione Irccs Policlinico S. Matteo

    Pavia, Italy

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, Italy

  • Nuovo Ospedale

    Prato, Italy

  • Azienda Opspedaliero Universitaria Santa Maria Della Misericordia

    Udine, Italy

  • Ospedale Ss Giovanni E Paolo

    Venezia, Italy

Poland
  • Bialostockie Centrum Onkologii Im. Marii Sklodowskiej - Curie

    Bialystok, Poland

  • Wojewódzkie Centrum Onkologii

    Gdansk, Poland

  • Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli

    Lublin, Poland

  • Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu

    Poznan, Poland

  • Mrukmed. Lekarz Beata Madej Mruk I Partner. Spólka Partnerska Oddzial Nr 1 W Rzeszowie

    Rzeszów, Poland

  • Magodent Sp. Z O. O.

    Warsaw, Poland

Spain
  • Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica

    A Coruña, Galicia, Spain

  • Complejo Hospitalario Universitario la Coruña

    A Coruña, Spain

37 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ReparixinPaclitaxel →Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Jul 2015
Primary completion
20 Feb 2019
Completion
23 Mar 2020
Last update posted
16 Sept 2022
Registered enrollment
194
Registry id
NCT02370238

Cross-registrations

EU-CTR / CTIS (EudraCT)2014-004796-23
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.