Clinical Trial Details

EORTC-1965-BCG

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De-Escalation of adjuvant ChemotheRapy in HER2-positive, EStrogen reCEptor-negative, Node-negative early breast cancer patients who achieved pathological complete response after neoadjuvant chemotherapy and Dual HER2 blOckade

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 19-Jan-2022
Date Step1 close: 02-Oct-2023
Date Step2 close: 02-Oct-2023
Data management at EORTC No
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 185 - All Groups: 1330
Treatment Radiotherapy, Surgery, Drug
Docetaxel, Pertuzumab, Paclitaxel, Trastuzumab, Trastuzumab emtansine
Study Staff Etienne Brain (Study Coordinator) , Institut Curie - l' Hopital de St Cloud, SAINT CLOUD
Laila Ben Salama (Clinical Operations Manager) , EORTC Headquarters, Brussels
Jessica Berger (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Luminita Copaceanu (Lead CRA) , EORTC Headquarters, Brussels
Corinne Daumer (Project Manager) , EORTC Headquarters, Brussels
Ana Joaquim (Clinical Research Physician) , EORTC Headquarters, Brussels
Coralie Poncet (Statistician) , EORTC Headquarters, Brussels
Yulia Roshchupkina (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Ward Sents (Clinical Scientist) , EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
Breast International Group
Recruiting centers CH de La Cote Basque - Saint Leon (Bayonne, France)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium)
Heilig Hartziekenhuis Lier (Lier, Belgium)
Hirslanden Klinik-Tumor Zentrum Aarau (Aarau, Switzerland)
Hopital Daler- Brustzentrum (Fribourg / Freiburg, Switzerland)
Institut Bergonie (Bordeaux, France)
Institut Curie - l' Hopital de St Cloud (SAINT CLOUD, France)
Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium)
Protocol summary http://clinicaltrials.gov/study/NCT04675827
NCT number NCT04675827
EudraCT 2020-002918-41
Financial Support BIG