Actively Recruiting
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
Eligibility Criteria
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.
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
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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