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Clinical Trials/NCT05396612
NCT05396612
Recruiting
Not Applicable

Role of the Immune Environment in Response to Therapy in Breast Cancer

Abramson Cancer Center at Penn Medicine1 site in 1 country300 target enrollmentOctober 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Abramson Cancer Center at Penn Medicine
Enrollment
300
Locations
1
Primary Endpoint
Collecting, processing and archiving breast cancer tumor tissues
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.

Registry
clinicaltrials.gov
Start Date
October 3, 2022
End Date
December 31, 2032
Last Updated
9 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Zhang

Assistant Professor of Surgery

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Collecting, processing and archiving breast cancer tumor tissues

Time Frame: Through study completion, average of 2 years

This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers.

Secondary Outcomes

  • Associating breast cancer dendritic cell infiltrate with outcome(5 years)

Study Sites (1)

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