Impact of Neoadjuvant Immunotherapy in Early Stage Breast Cancer Before Standard Therapy
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
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.