Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

March 31, 2017

Study Completion Date

November 30, 2022

Conditions
Elderly Metastatic Breast Cancer Population
Interventions
DRUG

Pertuzumab + trastuzumab

"Trastuzumab: loading dose of 8 mg/kg of body weight on cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks.~Pertuzumab: loading dose of 840 mg on cycle 1, followed by 420 mg for subsequent cycles, every 3 weeks.~if T-DM1: 3.6 mg/kg IV, every 3 weeks."

DRUG

Pertuzumab + trastuzumab + metronomic chemotherapy

Pertuzumab and trastuzumab will be administered as in arm A. Cyclophosphamide: daily dose of 50 mg/day. if T-DM1: as in arm A

Trial Locations (30)

Unknown

UZ Antwerpen, Antwerp

Cliniques Universitaires Saint-Luc, Brussels

Institut Jules Bordet, Brussels

Hopital De Jolimont, Haine-Saint-Paul

AZ Groeninge Kortrijk, Kortrijk

UZ Leuven, Leuven

CHU Sart-Tilman, Liège

Clinique et Maternité Sainte Elisabeth, Namur

AZ Damiaan, Ostend

AZ Nikolaas, Sint-Niklaas

Centre Georges-Francois-Leclerc, Dijon

Centre Oscar Lambret, Lille

Hopital Rene Huguenin - Institut Curie, Saint-Cloud

Centre Paul Strauss, Strasbourg

Istituto Europeo Di Oncologia, Milan

Istituto Oncologico Veneto IRCCS - Ospedale Busonera, Padua

Leiden University Medical Centre, Leiden

VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo, Venlo

Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw

Champalimaud Cancer Center, Lisbon

Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon

Sahlgrenska Universitetssjukhuet, Gothenburg

Ryhov County Hospital, Jönköping

Uppsala University Hospital - Akademiska Sjukhuset, Uppsala

Vastmanland Centralsjukhuset Vasteras, Västerås

Velindre NHS Trust - Velindre Cancer Centre, Cardiff

NHS Lothian - Western General Hospital, Edinburgh

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow

Peterborough and Stamford Hospitals NHS Foundation Trust - Peterborough City Hospita, Peterboroug

University Hospital Southampton NHS Foundation Trust - Southampton General Hospital, Southampton

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

NCT01597414 - Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1 | Biotech Hunter | Biotech Hunter