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

NCT ID: NCT05877859

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2027-04-10

Brief Summary

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.

Detailed Description

Primary Objective:

I. To determine whether standard of care neoadjuvant chemo-immunotherapy leads to the induction of a pro-inflammatory cytokine milieu (characterized by high IFN- γ, IFN-α, IL-6 and low TGF-β) in the blood which is induced within 24 hours of treatment initiation, persists through the course of the therapy and is associated with pathologic complete response in the tissue.

Secondary Objectives:

I. To determine whether the spatially resolved tissue TGF-β induced transcriptomic signatures or lack of innate interferon inducible genes/effector CD8 modules are abundant in tumors from TNBC patients that do not show pathologic complete response in the tissue at the end of standard of care neoadjuvant chemo- immunotherapy.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer
• Estrogen receptor IHC expression ≤10%; progesterone receptor IHC expression ≤ 10%; HER2 negative
• HER2 negativity is defined as either of the following by local laboratory assessment:
• IHC 0, 1+, or 2+ and In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 <2.0 or single probe average HER2 gene copy number <4 signals/cell)
• No prior chemotherapy, endocrine therapy, or immunotherapy
• Willingness and ability of the subject to comply with scheduled visits, standard of care drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
• Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.
• Patients on steroid medications (i.e. prednisone, dexamethasone, etc.) that are not part of the standard pre-medications and/or take home medications that are included as a part of medication regimen for the pre-operative chemo-immunotherapy described in the study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ruth Sacks

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruth Sacks, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ruth Sacks, MD

Role: CONTACT

rlsacks@emory.edu

404-778-1900

Facility Contacts

Ashley Trumbull

Role: primary

ashley.lynn.trumbull@emory.edu

404-778-3969

Other Identifiers

NCI-2023-02943

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00005452

Identifier Type: OTHER

Identifier Source: secondary_id

WINSHIP5818-22

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005452

Identifier Type: -

Identifier Source: org_study_id