Tumor microenvironment changes after therapy in HER2‑positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.