Status:
NOT_YET_RECRUITING
Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients
Lead Sponsor:
Giampaolo Bianchini
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 canc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06518382
Start Date
August 1 2024
End Date
August 1 2027
Last Update
July 24 2024
Active Locations (1)
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1
IRCCS San Raffaele Hospital
Milan, Lombardy, Italy, 20132