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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05396612
Enrollment
300
Registered
2022-05-31
Start date
2022-10-03
Completion date
2032-12-31
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Immune microenvironment

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.

Interventions

OTHERCollection 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.

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Collecting, processing and archiving breast cancer tumor tissuesThrough study completion, average of 2 yearsThis 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

MeasureTime frameDescription
Associating breast cancer dendritic cell infiltrate with outcome5 yearsWe 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.

Countries

United States

Contacts

Primary ContactJulia T. Lewandowski
Julia.Lewandowski@Pennmedicine.upenn.edu215-662-2861
Backup ContactJennifer Zhang, MD
Jennifer.Zhang@Pennmedicine.upenn.edu215-615-6810

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026