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A Retrospective Observational Study Characterizing Tumour-microenvironment Spatial Interaction Aimed at the Identification of New Markers of Resistance to Therapy in HER2-positive Breast Cancer Patients

Status: Recruiting
Location: See location...
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 regions of each specimen will be analyzed with the ultimate goal to identify new biomarkers (and putative targets) of resistance to therapy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Italy
IRCCS San Raffaele Hospital
RECRUITING
Milan
Contact Information
Primary
Tiziana Daniele, PhD
daniele.tiziana@hsr.it
+39 02 2643 6381
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2027-08
Participants
Target number of participants: 10
Related Therapeutic Areas
Sponsors
Leads: Giampaolo Bianchini

This content was sourced from clinicaltrials.gov