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Clinical trialNCT03786094TerminatedPhase 3Interventional

Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

SponsorSpexis AGEnrollment432Locally Recurrent Breast CancerMetastatic Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.
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

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

Argentina
  • Centro Polivalente de Asistencia E Investigación Clínica - Cer San Juan

    San Juan, Buenos Aires, Argentina

  • Centro de Investigación Clínica - Clínica Viedma

    Viedma, Río Negro Province, Argentina

  • Sanatorio Parque de Rosario

    Rosario, Santa Fe Province, Argentina

  • Caipo Centro Para la Atención Integral del Paciente Oncológico

    San Miguel de Tucumán, Argentina

Belgium
  • Grand Hopital de Charleroi Asbl

    Charleroi, Hainaut, Belgium

  • Uz Antwerpen

    Antwerp, Belgium

  • Chirec Centre Hospitalier Interregional Edith Cavell

    Brussels, Belgium

  • Uz Gent

    Ghent, Belgium

  • Chu de Liège

    Liège, Belgium

Brazil
  • Centro de Oncologia Da Bahia

    Bahia, Brazil

  • Universidade de Caxias Do Sul (ipcem-Ucs)

    Caxias do Sul, Brazil

  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

    Curitiba, Brazil

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (pucrs)

    Porto Alegre, Brazil

  • Inca Instituto Nacional de Cancer

    Rio de Janeiro, Brazil

  • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

    São José do Rio Preto, Brazil

  • Clinica de Pesquisas E Centro de Estudos Oncologia Ginecologica E Mamaria Ltda

    São Paulo, Brazil

Czechia
  • Multiscan S.R.O - Onkologická Ambulance

    Hořovice, Czechia

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, Czechia

  • Fakultni Nemocnice V Motole

    Prague, Czechia

France
  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

    Lyon, France

  • Institut de Cancérologie de L'Ouest

    Saint-Herblain, France

  • Edog - Institut Claudius Regaud - Ppds

    Toulouse, France

Italy
  • Ospedale San Raffaele S.R.L. - Ppds

    Milan, Lombardy, Italy

  • Asst Di Monza - Azienda Ospedaliera San Gerardo

    Monza, Milano, Italy

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, Italy

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Italy

  • Azienda Ospedaliera Universitaria - Università Degli Studi Della Campania "luigi Vanvitelli"

    Naples, Italy

Russia
  • Llc Evimed

    Chelyabinsk, Russia

  • Krasnoyarsk Regional Oncology Center N.A. A.I. Kryzhanovskiy

    Krasnoyarsk, Russia

  • Medical Center Tonus

    Nizhny Novgorod, Russia

  • Budgetary Healthcare Institution of the Omsk Region "clinical Oncology Dispensary"

    Omsk, Russia

  • Evromedservis Lcc

    Pushkin, Russia

  • Mordovia State University

    Saransk, Russia

  • Research Oncology Institute of Tomsk Scientific Center

    Tomsk, Russia

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd, Russia

South Korea
  • National Cancer Center

    Goyang-si, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Ulsan University Hospital

    Ulsan, South Korea

Spain
  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, Spain

48 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.

BalixafortideEribulin →
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
30 May 2019
Primary completion
19 Oct 2021
Completion
19 Oct 2021
Last update posted
1 Nov 2023
Registered enrollment
432
Registry id
NCT03786094
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.