NSABP B-59/GBG 96-GeparDouze
EudraCT-No.: 2017-002771-25
EUCT-No: 2023-508472-11-00
A joint study of NSABP Foundation , Inc. and the German Breast Group (GBG)
NSABP B-59/GBG 96-GeparDouze
EudraCT-No.: 2017-002771-25
EUCT-No: 2023-508472-11-00
A joint study of NSABP Foundation , Inc. and the German Breast Group (GBG)
Introduction
In this clinical trial of neoadjuvant and adjuvant administration of atezolizumab/placebo in patients with high risk triple-negative breast cancer, the potential incremental efficacy and safety of neoadjuvant administration of atezolizumab/placebo with a sequential regimen of weekly paclitaxel with every-3-week carboplatin followed immediately by neoadjuvant administration of atezolizumab/placebo with AC/EC will be evaluated.
Patients will then undergo surgery (should be performed within 6 weeks after last chemotherapy application). Following recovery from surgery, patients will initiate approximately 6 months of adjuvant therapy with atezolizumab/placebo and receive the same investigational agent they received pre-operatively.
News
Recruitment ended on May 28, 2021.
Changes with Protocol Amendment 5:
- Adaptation to the EU CTR
Design
A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo
The inclusion and exclusion criteria, as well as more detailed information on the study design, can be found in the short protocol on the list of documents.
Contact
K. Hesse
