Observational Study on Immune Environment in Breast Cancer

This observational study is looking at how the immune system around breast cancer cells might affect how well treatments work. Researchers will collect personal health information and breast cancer tissue samples from women treated at the University of Pennsylvania. They will compare the immune environments of ER+HER2- (estrogen receptor positive, HER2 negative) breast cancers with triple-negative and HER2+ breast cancers. This study is for women aged 18 or older with non-metastatic breast cancer who are having surgery at the University of Pennsylvania Health System. The main goal is to collect and store these tissue samples. The study status is currently unclear.

Study design
This is an observational case-control study, meaning researchers will compare groups of participants without giving new treatments. Around 300 women are planned to participate.
What's involved
You would allow researchers to collect your personal health information and breast cancer tumor tissues. This collection would happen through study completion, which averages 2 years.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint involves collecting, processing, and archiving breast cancer tumor tissues through study completion, which averages 2 years.

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NCT05396612

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

Recruiting
Not specifiedAges 18+Observational
Abramson Cancer Center at Penn Medicine
~300 participants
Updated 2025-07-08 on ClinicalTrials.gov
What's tested:Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collecting, processing and archiving breast cancer tumor tissues
Measured over Through study completion, average of 2 years
Breast Cancer
ER Positive Breast Cancer
HER2-negative Breast Cancer
TNBC - Triple-Negative Breast Cancer
1 sites across 1 states
Pennsylvania1
  • Jennifer Zhang, MD · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center

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  • Collecting, processing and archiving breast cancer tumor tissuesThrough 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.