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Observational Study of Pembrolizumab for Early-Stage Triple Negative Breast Cancer

This research study is looking at how the immune system responds in people with early-stage triple negative breast cancer (TNBC). Participants will receive standard chemotherapy and immunotherapy with pembrolizumab. Researchers want to see if this treatment changes certain immune signals (cytokines) in the blood and if these changes are linked to how well the cancer responds. You may be able to join if you are a woman, at least 18 years old, and have newly diagnosed, untreated Stage II or III TNBC that is HER2 negative. The study aims to enroll 10 participants. The current recruitment status is unclear.

Study design
This is an observational, single-arm pilot study, meaning all participants will receive the same treatment and there isn't a comparison group. It plans to enroll 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal involves measuring changes in blood cytokines within 24 hours of surgery, but overall follow-up duration is not specified.

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NCT05877859

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

Recruiting
Not specifiedAges 18+Observational
Emory University
~10 participants
Updated 2026-05-07 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the cytokine milieu in the blood
Measured over From baseline within 24 hours of surgery

Conditions

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

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Breast Carcinoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Ruth Sacks, MD · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Ruth Sacks, MD
[email protected]
404-778-1900
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in the cytokine milieu in the bloodFrom baseline within 24 hours of surgery

    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