Recruiting

Immune Environment

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT05396612

Conditions

Breast Cancer

ER Positive Breast Cancer

HER2-negative Breast Cancer

TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05396612

Start date

Oct 3, 2022

Status verified date

Jul, 2025

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

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

Primary outcome measure

  • Collecting, processing and archiving breast cancer tumor tissues [ Time Frame: Through study completion, average of 2 years ]

Central Contacts and Locations

Central contacts

Julia T. Lewandowski

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

Jennifer Zhang, MD

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

Locations

Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jul 8, 2025

Last verified

Jul, 2025

Keywords

  • Immune microenvironment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2025-07-08.