Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05877859
Status
Recruiting

Conditions

  • Breast Cancer Invasive
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Breast Cancer Triple Negative

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

This research study is a prospective, single arm, pilot study, designed to evaluate the correlation between the immune and clinical responses of subjects with untreated Stage II-III triple negative breast cancer (TNBC) undergoing standard of care neoadjuvant chemo- immunotherapy.

Key Dates

Start date
May 30, 2023
Status verified
May 2026
Primary completion
Feb 20, 2027
Completion
Feb 20, 2028

Study Design

Enrollment
10 participants (estimated)

Primary Outcome Measure

Change in the cytokine milieu in the blood [ Time Frame: From baseline within 24 hours of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University/Winship Cancer InstituteAtlantaGeorgia30322
Ashley Trumbull
404-778-3969
Ruth Sacks, MD (PRINCIPAL_INVESTIGATOR)

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