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

Recruiting

• Conditions: HER2-negative Breast Cancer; ER Positive Breast Cancer; Breast Cancer; TNBC - Triple-Negative Breast Cancer

• Registration Number: NCT05396612
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2022-10-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Primary Completion: 2032-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collecting, processing and archiving breast cancer tumor tissues	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 Outcome Measures

Name	Time	Method
Associating breast cancer dendritic cell infiltrate with outcome	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.

Trial Locations

Locations (1)

Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States