NCT07597642Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 55 (estimated)
First submitted: 8 May 2026
Start date: 1 Sept 2026
Primary completion date: 30 Sept 2028
Lead sponsor: IRCCS San Raffaele
Diseases: Triple-negative breast cancer
NCT number: NCT07597642

What you commit to

Study type: Interventional
Planned participants: 55
From 1 Sept 2026 to the primary completion date, 30 Sept 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Known metastatic disease. 4 Clinical contraindications to the planned neoadjuvant therapy.
- 5\. 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

Other

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.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status	Milan	Italy	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.