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
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 |