Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in
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 com
| Condition(s) | HER2-positive Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 reg |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Giampaolo Bianchini |
| Locations | Milan, Lombardy, Italy |
| Start date | 2024-12-10 |
| NCT ID | NCT06518382 |
| Official listing | https://clinicaltrials.gov/study/NCT06518382 |