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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; HER2-negative Breast Cancer; TNBC - Triple-Negative Breast Cancer; ER Positive Breast Cancer
• Intervention / Treatment: Other: Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Julia T. Lewandowski; Phone Number: 215-662-2861; Email: Julia.Lewandowski@Pennmedicine.upenn.edu
• Study Contact Backup: Name: Jennifer Zhang, MD; Phone Number: 215-615-6810; Email: Jennifer.Zhang@Pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women 18 years of age or older undergoing surgery for breast cancer.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Jennifer Zhang, MD, Abramson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Immune microenvironment
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: UPCC 19121; 850338 (Other Identifier: University of Pennsylvania)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No