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

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms ER Positive Breast Cancer HER2-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases TNBC - Triple-Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System.

Exclusion criteria

Males Children Pregnant individuals

Treatment and study plan

Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.

Other

Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.

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

Time frame: 5 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Zhang, MD

CONTACT

[email protected]

215-615-6810

Julia T. Lewandowski

CONTACT

[email protected]

215-662-2861

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2032
Study completion: 2032
First posted: May 31, 2022
Registry last updated: Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting