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

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Conditions studied: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

In brief

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 facts

Study ID

NCT07597642

Run by

IRCCS San Raffaele

People needed

55

Starts

2026-09-01

Expected to finish

2029-03-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged ≥18 years.
• ECOG performance status 0-1.
• Histologically confirmed early breast cancer with one of the following molecular profiles:
• TNBC: ER and PR negative (IHC <10%) and HER2 negative (IHC 0-1+ or FISH non-amplified).
• High-risk luminal (ER+/HER2-): ER positive (IHC ≥10%) HER2 negative (IHC 0-1+ or FISH non-amplified), with high-risk features (e.g., Grade 3, PR-negative, high proliferation, high TILS).
• Clinical indication for neoadjuvant treatment according to standard practice:
• TNBC: cT1c and/or cN positive, or cT2 (>2 cm) and/or cN positive (stage II,III).
• High-risk luminal: features as defined above (Grade 3, PR-negative, high proliferation, ER low).
• Ability to understand and sign written informed consent for participation in the study, approved by the local Ethics Committee.

You may not qualify if…

• HER2-positive tumors.
• Multifocal tumors - exclusion if a single index lesion cannot be identified and sampled; otherwise allowed if a representative lesion can be biopsied.
• Known metastatic disease. 4 Clinical contraindications to the planned neoadjuvant therapy.
• Decision for upfront surgery as determined by the multidisciplinary team. 6. Inability to provide informed consent. 7. Pregnancy or breastfeeding. 8. Prior systemic therapy (chemotherapy, immunotherapy, or endocrine therapy) for the current breast cancer before baseline biopsy 9. On-treatment biopsy clinically not feasible or controindicated

Where it is running

• IRCCS Ospedale San Raffaele — Milan, Lombardy, Italy

Full record on ClinicalTrials.gov

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