MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

November 13, 2018

Primary Completion Date

February 23, 2024

Study Completion Date

February 23, 2024

Conditions
Advanced or Metastatic Breast Cancer
Interventions
DRUG

MEN1611

MEN1611 oral dose administered twice daily for a continuous 28-day cycle

DRUG

Trastuzumab

Trastuzumab solution for infusion administered weekly via IV

DRUG

Fulvestrant

Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)

Trial Locations (27)

33308

Holy Cross Hospital Inc., Fort Lauderdale

48334

Detroit Clinical Research Center, Farmington Hills

63130

Washington University, St Louis

Unknown

Cliniques Universitaires Saint-Luc, Brussels

Institut Jules Bordet, Brussels

UZ Leuven, Leuven

Centre Georges François Leclerc, Dijon

Centre Oscar Lambret, Lille

Institut Régional du Cancer de Montpellier, Montferrier-sur-Lez

ICO - Site René Gauducheau, Saint-Herblain

Institut Claudius Regaud Oncopole, Toulouse

Institut Gustave Roussy, Villejuif

Azienda Ospedaliero Universitaria Mater Domini, Catanzaro

Istituto Clinico Humanitas, Milan

Istituto Europeo di Oncologia (IEO), Milan

Ospedale San Raffaele, Milan

Hospital Clínic i Provincial de Barcelona, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

Centro Integral Oncologico Clara Campal, Madrid

Hospital General Universitario Gregorio Marañon, Madrid

START Madrid Fundacion Jimenez Diaz, Madrid

Hospital Clínico Universitario Virgen de la Victoria, Málaga

Hospital Universitario Virgen del Rocío, Seville

Velindre Cancer Centre, Cardiff

Sarah Cannon Research Institute UK, London

University College London Hospitals, London

The Christie, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Menarini Group

INDUSTRY

NCT03767335 - MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter