ALEXANDRA/IMPASSION030 (GBG 98)

A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH ADJUVANT ANTHRACYCLINE/TAXANE-BASED CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE IN PATIENTS WITH OPERABLE TRIPLE-NEGATIVE BREAST CANCER

 

 

 

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A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH ADJUVANT ANTHRACYCLINE/TAXANE-BASED CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE IN PATIENTS WITH OPERABLE TRIPLE-NEGATIVE BREAST CANCER

BIG16-05/AFT-27/WO39391

 

Introduction

ATEZOLIZUMAB (Anti PD-L1 Antibody) in Combination with Adjuvant Anthracycline/Taxan-based Chemotherapy versus Chemotherapy alone in patients with operable triple negative breast cancer.

 

News

Dear GBG trial centers,
As suggested at the GBG annual meeting in March 2020, it should always be possible for centers of a study group to refer patients to a participating center in order to enable high-risk patients to participate in the study.
The German Cancer Society also recognizes this, which is why referred patients can also be counted without cooperation agreements.
- A study network is a pro for center certification.

 

Design

Primary study objective
Comparison of IDFS (Invasive disease free survival) rates after adjuvant therapy

Patient Profile
• Stage II –III (pT2-pT3, PT0-pT1 if nodal positive)
What is a stage II-III tumor?
Any nodal-positive tumor (regardless of size) & nodal-negative tumors >2cm in size
• Confirmed TNBC Status