Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy

Summary

This is a randomized, open-label, adaptive, two arm, multicentre, Phase II trial comparing a neoadjuvant chemotherapy with PDL1-inhibition (Atezolizumab) and Atezolizumab two-week window to chemotherapy with PDL1-inhibition (Atezolizumab) and identify biomarkers predicting (early) response to or resistance against Atezolizumab (alone and with CTX) allowing patients stratification in future clinical trials

Timeline

Start

2021-03-01

Primary completion

2023-07-06

Completion

2024-10-02

Outcome

Missed primary endpoint

Stopped (Enrollment): “The trial stopped recruitment prematurely after a first planned interim analysis of the first 100 pCR results (given that a probability of less than 2.5% of meeting the primary endpoint was estimated).”

registry analysis (superiority test); Arm A vs Arm B; Risk Difference (RD) -0.0327 (95% CI -0.1307 to 0.0663) NCT04770272 ↗

Publications

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• Background Kolberg-Liedtke C, Feuerhake F, Garke M, Christgen M, Kates R, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Kuemmel S, Wuerstlein R, Graeser M, Nitz U, Kreipe H, Gluz O, Harbeck N. Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial. Breast Cancer Res. 2022 Sep 2;24(1):58. doi: 10.1186/s13058-022-01552-w.
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Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	840 mg	—
Subject	Atezolizumab	Monoclonal antibody	1200 mg	—
Background	Carboplatin	Small molecule	2 unknown	Intravenous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	—
Background	Epirubicin	Small molecule	90 mg/m2	—
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications