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Clinical Trial Summary

The aim of this study is to determine, using immunohistochemistry (IHC) on biopsies and surgically removed tumor if short-treatment immunotherapy with atezolizumab monotherapy or in combination with other biologic agents (ipatasertib / Bevacizumab / Trastuzumab / Pertuzumab) is associated with increased levels of activated GzmB+ CD8+ T cells from baseline to post treatment sample. Moreover, from baseline to post treatment sample, evolution of others biomarkers will be studied : GzmB/CD8, CD8/FoxP3, CD8/CD68 in IHC, cell proliferation, PD-L1, MHC-I, change in gene expression (RNA-Seq). Tjis study aim also to assess the safety and tolerability of study treatments in this population and to determine the effect of short-term immunotherapy treatment in pCR at surgery. Patients will undergo tumor biopsies at screening and 15 days after the beginning of treatment (if they start neoadujavant chemotherapy) / at surgery, in order to evaluate in IHC evolution of activated GzmB+ CD8+ T cells and evaluate other markers It targets 2 different cohorts: newly diagnosed, non-metastatic early-stage triple-negative (TNBC) or HER2+ breast cancer. TNBC cohort is composed of 4 open-label, randomized arms, HER2+ of 2 arms. A maximum of 210 patients will be included in the trial (147 in TNBC cohort and 63 in HER2+ cohort). Tumor evaluation will be performed by clinical examination and Breast echography at baseline and end of treatment visit. The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests and through the collection of ongoing toxicities or adverse events.

Clinical Trial Description

Cohort 1 In TNBC patients t will be composed of 4 open-label, randomized arms: Arm 1A: control arm; no treatment Arm 1B: atezolizumab alone, administered as one single IV infusion on day -15 +/- 48 h (D1) prior to the date of surgery or the start of neoadjuvant chemotherapy Arm 1C: atezolizumab as one single IV infusion on day -15 +/- 48 h (D1) prior to the date of surgery or the start of neoadjuvant chemotherapy, in combination with daily oral ipatasertib for 14 days starting at the same time as atezolizumab administration Arm 1D: atezolizumab and bevacizumab as one single IV infusion on day -15 +/- 48 h (D1) prior to the date of surgery or the start of neoadjuvant chemotherapy Cohort 2 in HER2-positive patients will be composed of 2 arms: Arm 2A: no treatment Arm 2B: atezolizumab as one single IV infusion in combination with trastuzumab + pertuzumab for one IV infusion on day -15 +/- 48 h (D1) prior to the date of surgery or the start of neoadjuvant chemotherapy ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05180006
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Barbara Pistilli, Dr
Phone +33 (0)1 42 11 42 11
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date January 2022
Completion date February 2025

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