Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients

NCT ID: NCT06518382

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2027-08-31

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 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

HER2-positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Giampaolo Bianchini

OTHER

Sponsor Role: lead

Responsible Party

Giampaolo Bianchini

Head of Breast Cancer Group, Department of Medical Oncology -PI-

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giampaolo Bianchini, MD

Role: PRINCIPAL_INVESTIGATOR

Head Breast Cancer Group - Department of Medical Oncology - IRCCS San Raffaele Hospital

Locations

IRCCS San Raffaele Hospital

Milan, Lombardy, Italy

Countries

Italy

Central Contacts

Tiziana Daniele, PhD

Role: CONTACT

daniele.tiziana@hsr.it

+39 02 2643 6381

Facility Contacts

Giampaolo Bianchini, MD

Role: primary

bianchini.giampaolo@hsr.it

+39 02 2643 6530

References

Wang XQ, Danenberg E, Huang CS, Egle D, Callari M, Bermejo B, Dugo M, Zamagni C, Thill M, Anton A, Zambelli S, Russo S, Ciruelos EM, Greil R, Gyorffy B, Semiglazov V, Colleoni M, Kelly CM, Mariani G, Del Mastro L, Biasi O, Seitz RS, Valagussa P, Viale G, Gianni L, Bianchini G, Ali HR. Spatial predictors of immunotherapy response in triple-negative breast cancer. Nature. 2023 Sep;621(7980):868-876. doi: 10.1038/s41586-023-06498-3. Epub 2023 Sep 6.

Reference Type: BACKGROUND

PMID: 37674077 (View on PubMed)

Other Identifiers

TaME-HER2BrCa

Identifier Type: -

Identifier Source: org_study_id