Tumor microenvironment changes after therapy in HER2‑positive breast cancer
A Retrospective Observational Study Characterizing Tumour-microenvironment Spatial Interaction Aimed at the Identification of New Markers of Resistance to Therapy in HER2-positive Breast Cancer Patients
This project will compare tissue samples taken before and after standard neoadjuvant chemo plus trastuzumab to see if changes in the tumor microenvironment mark resistance in HER2‑positive breast cancer patients with residual disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06518382 on ClinicalTrials.gov |
What this trial studies
This retrospective observational project analyzes paired formalin‑fixed paraffin‑embedded tumor samples collected before and after standard neoadjuvant anthracycline followed by taxane chemotherapy with trastuzumab in HER2‑positive breast cancer patients who have residual invasive disease at surgery. Tumoral, peri‑tumoral, and stromal regions will be profiled using spatial techniques such as Imaging Mass Cytometry to map cell types and protein expression patterns. Investigators will compare tissue architecture and cellular interactions pre‑ and post‑therapy to identify biomarkers and potential therapeutic targets associated with resistance. No interventional treatments are given and the work uses only existing clinical samples and records.
Who should consider this trial
Good fit: Ideal candidates are HER2‑positive breast cancer patients who received standard neoadjuvant anthracycline and taxane chemotherapy with trastuzumab and have paired pre‑treatment biopsy and post‑treatment surgical FFPE samples showing residual invasive disease and can give consent.
Not a fit: Patients who achieved a complete pathological response (no residual invasive disease), lack pre‑ or post‑treatment tissue samples, or whose stored specimens are of insufficient quality for Imaging Mass Cytometry are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could reveal biomarkers that predict or explain resistance and suggest new targets to improve treatment for HER2‑positive patients.
How similar studies have performed: Prior spatial‑profiling and microenvironment studies have identified markers linked to treatment resistance, but using paired pre/post Imaging Mass Cytometry specifically in HER2‑positive residual disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Patient underwent the following procedure before surgery: biopsy, sequential chemotherapy comprising treatment with antracyclines (AC/EC q21, 4 cycles) followed by taxanes (paclitaxel 1,8,15 q21 for 12 weeks) in combination with the anti-HER2 antibody trastuzumab. 3. Specimen collected at surgery display residual invasive disease in the breast/lymph node. Exclusion Criteria: 1. pre-existing conditions or concurrent diagnoses; 2. concomitant use of other medications during neo-adjuvant treatment; 3. quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis.
Where this trial is running
Milan, Lombardy
- IRCCS San Raffaele Hospital — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Giampaolo Bianchini, MD — Head Breast Cancer Group - Department of Medical Oncology - IRCCS San Raffaele Hospital
- Study coordinator: Tiziana Daniele, PhD
- Email: daniele.tiziana@hsr.it
- Phone: +39 02 2643 6381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.