About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Women 18 years of age or older undergoing surgery for breast cancer.
Trial design
Case-control
Prospective
Treatments tested in this trial
Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.
Other interventionCollection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.
Treatment groups
Trial outcomes
Primary outcomes
Collecting, processing and archiving breast cancer tumor tissues
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
We will perform studies to associate dendritic cell infiltration and activation markers with patient outcome, including disease free survival, distant disease free survival, and overall survival.
Sponsors and contacts
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