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Trial Title:
Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
NCT ID:
NCT05877859
Condition:
Breast Cancer Triple Negative
Breast Cancer Stage II
Breast Cancer Stage III
Breast Cancer Invasive
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Emory University/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Investigator:
Last name:
Ruth Sacks, MD
Email:
Principal Investigator
Start date:
May 30, 2023
Completion date:
April 10, 2026
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05877859
