Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518382
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2 Breast Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 breastlymph 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None