Study

EORTC-1965-BCG

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 Back to result

Trial Status

All trial activities ended

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
  • Corinne Daumer (Project Manager), EORTC Headquarters, Brussels
  • Ana Joaquim (Clinical Research Physician), EORTC Headquarters, Brussels
  • Ward Sents (Clinical Scientist), EORTC Headquarters, Brussels
  • Coralie Poncet (Statistician), EORTC Headquarters, Brussels
  • 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
  • Yulia Roshchupkina (Clinical Operations Assistant), EORTC Headquarters, Brussels

Type of cancer

  • Breast

Participating groups

  • EORTC Breast Cancer Group
  • Breast International Group

Recruiting centers

  • AZORG (previous Onze Lieve Vrouw ZK) (Aalst, Belgium)
  • 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)
  • 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)
  • ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Centers to be activated

  • Azienda Istituti Ospitalieri di Cremona (Cremona, Italy)
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna (Torino, Italy)
  • Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy)
  • U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
  • ZAS Palfijn (Merksem, Belgium)

Protocol summary

http://clinicaltrials.gov/study/NCT04675827

NCT number

NCT04675827

EudraCT

2020-002918-41