Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients
Recruiting now
Conditions studied: HER2-positive Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06518382
- Run by
- Giampaolo Bianchini
- People needed
- 10
- Starts
- 2024-12-10
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Participant is willing and able to give informed consent for participation in the study.
- 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.
- Specimen collected at surgery display residual invasive disease in the breast/lymph node.
You may not qualify if…
- pre-existing conditions or concurrent diagnoses;
- concomitant use of other medications during neo-adjuvant treatment;
- quality of stored specimen does not meet the standard for Imaging Mass Cytometry analysis.
Where it is running
- IRCCS San Raffaele Hospital — Milan, Lombardy, Italy (enrolling)
Full record on ClinicalTrials.gov
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