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.
Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer
Estrogen receptor IHC expression ≤10%; progesterone receptor IHC expression ≤ 10%; HER2 negative
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
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.
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.
Cohort
Prospective
Not listed
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
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.
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
