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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05396612
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 126
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Role of the Immune Environment in Response to Therapy in Breast Cancer
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2032
• Anticipated Study Completion Date: Dec 31, 2032

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Jennifer Zhang, MD, Abramson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Zhang, Assistant Professor of Surgery, Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT05396612
• Other Study ID Numbers: 850338; UPCC 19121
• First Posted: May 31, 2022
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jennifer Zhang, Assistant Professor of Surgery, Abramson Cancer Center of the University of Pennsylvania: Immune microenvironment
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms

Study Results

No Results Posted as of May 31, 2022