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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396612
• Other study ID #: UPCC 19121
• Secondary ID: 850338
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: April 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Julia T. Lewandowski
• Phone: 215-662-2861
• Email: Julia.Lewandowski[@]Pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• ER Positive Breast Cancer
• HER2-negative Breast Cancer
• TNBC - Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Associating breast cancer dendritic cell infiltrate with outcome	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.	5 years