Actively Recruiting

Age: 18Years +
FEMALE
NCT06518382

Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients

Led by Giampaolo Bianchini · Updated on 2026-04-15

10

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This retrospective observational study aims at the comparison of the tumour-microenvironment tissue architecture before and after neo-adjuvant therapy in samples from HER2-positive (HER2+) breast cancer (BrCa) patients that display residual invasive disease in the breast/lymph node at surgery after standard-of-care combined chemotherapy and trastuzumab treatment. The working hypothesis of the investigators is that: Therapy imposes a selective pressure on tumour-microenvironment features promoting resistance to treatment. Participant that have already undergone neo-adjuvant treatment as part of their regular medical care for HER2-positive breast cancer will provide access to formalin-fixed paraffin-embedded (FFPE) samples taken before and after therapy. Tumoral, peri-tumoral and stromal regions of each specimen will be analyzed with the ultimate goal to identify new biomarkers (and putative targets) of resistance to therapy.

CONDITIONS

Official Title

Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is willing and able to give informed consent for participation in the study.
  • Patient underwent biopsy before surgery and sequential chemotherapy with anthracyclines followed by taxanes combined with trastuzumab.
  • Surgical specimen shows residual invasive disease in the breast or lymph node.
Not Eligible

You will not qualify if you...

  • Pre-existing conditions or other diagnoses.
  • Use of other medications during neo-adjuvant treatment.
  • Stored tissue specimen quality is insufficient for Imaging Mass Cytometry analysis.

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS San Raffaele Hospital

Milan, Lombardy, Italy, 20132

Actively Recruiting

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Research Team

T

Tiziana Daniele, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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