Breast Cancer Triple NegativeNCT05877859
Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
An observational study of Breast Cancer Triple Negative and Breast Cancer Stage II, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Triple Negative, Breast Cancer Stage II, Breast Cancer Stage III
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 20 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Ashley Trumbull, 404-778-3969, ashley.lynn.trumbull@emory.edu
Ruth Sacks, MD
About this study
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.
Read the detailed description
Primary Objective:
- 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:
- 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
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline within 24 hours of surgery
Secondary outcomes (1)
Change in the transcriptomic signatures in the tissue
The transcriptomic signatures of TGF-β induced genes and innate interferon inducible genes/effector CD8 in the tissue specimens collected at baseline (archival tissue obtained prior to standard of care neoadjuvant chemo- immunotherapy) and after completion of treatment at the time of surgery.
Measured: From baseline within 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start30 May 2023
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Triple NegativeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ruth Sacks, Emory University
- Investigators
- Ruth Sacks, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877859
- Sponsor's protocol ID
- STUDY00005452
- Other IDs
- NCI-2023-02943, STUDY00005452, WINSHIP5818-22, P30CA138292
- Status last verified
- May 2026
- First submitted
- 18 May 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
- ClinicalTrials.gov ID
- NCT05877859
- Acronym / sponsor ID
- STUDY00005452
- Conditions
- Breast Cancer Triple Negative, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Invasive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the cytokine milieu in the blood
Time frame: From 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
1 secondary outcome
Change in the transcriptomic signatures in the tissue
Time frame: From baseline within 24 hours of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruth Sacks, MD principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Triple Negative and Breast Cancer Stage II, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Sacks, MD (404-778-1900, rlsacks@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the cytokine milieu in the blood (time frame: From baseline within 24 hours of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.