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ON-treatment Single-cell Analysis for the Identification of Early Tumor Response Biomarkers on Prospective Collected Serial Tumor Biopsies in Triple Negative Breast Cancer Patient During Standard Neoadjuvant Chemo-immunotherapy
Sponsor: IRCCS San Raffaele
Summary
This study explores early breast cancer, focusing on triple-negative and high-risk luminal subtypes. It combines single-cell RNA sequencing and spatial imaging of tumor samples collected at different time points during treatment. The aim is to better understand how cancer cells and immune cells interact and to identify biomarkers that can predict whether a patient will respond to chemo-immunotherapy or develop resistance. The study assumes that early molecular and spatial changes at the single-cell level can predict treatment response. This knowledge could help doctors adapt therapies, avoiding unnecessary treatment while improving effectiveness. The project seeks to reveal, for the first time, how cellular diversity and spatial relationships contribute to treatment resistance and disease progression. Tumor samples will be analyzed before treatment, after the first treatment cycle (C1D1), and at surgery. Only the biopsy taken after C1D1 is collected specifically for this study; all other samples come from routine clinical care.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2026-09
Completion Date
2029-03
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
on treatment biopsy (after C1)
Serial tumor tissue collection and analysis for the identification of early tumor response biomarkers. Tumor samples will be obtained at three predefined time points: (i) prior to initiation of treatment (baseline biopsy), (ii) after Cycle 1 Day 1 (C1D1) of therapy, and (iii) at the time of surgery (surgical specimen)
Locations (1)
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy