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

NCT05396612 | Recruiting

• 2 other identifiers: UPCC 19121850338
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; ER Positive Breast Cancer; HER2-negative Breast Cancer; TNBC - Triple-Negative Breast Cancer

Keywords

Immune microenvironment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Associating breast cancer dendritic cell infiltrate with outcome

  5 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Males Children Pregnant individuals

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue from breast tumors removed as standard of care treatment for breast cancer.

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Zhang, MD

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia T. Lewandowski

CONTACT

215-662-2861; Julia.Lewandowski@Pennmedicine.upenn.edu

Jennifer Zhang, MD

CONTACT

215-615-6810; Jennifer.Zhang@Pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 31, 2022
• Study Start: October 3, 2022
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)