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

NCT05877859 | Recruiting

• 4 other identifiers: STUDY00005452NCI-2023-02943WINSHIP5818-22P30CA138292
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in the cytokine milieu in the blood

  The change in the cytokine milieu specifically IFN-γ, IFN-α, IL-6 and TGF-β in the blood during standard of care neoadjuvant chemo-immunotherapy and its association with pathologic complete response in the tissue

  From baseline within 24 hours of surgery

Secondary Outcomes (1)

• Change in the transcriptomic signatures in the tissue

  From baseline within 24 hours of surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients enrolled to the study who started at least one-dose of standard of care neoadjuvant chemo-immunotherapy with blood samples available for pre- and \<=24 hour post-infusion at first cycle.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ruth Sacks, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Sacks, MD

CONTACT

404-778-1900; rlsacks@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: May 30, 2023
• Primary Completion: April 10, 2026
• Study Completion (Estimated): April 10, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)