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Clinical Trial Summary

To learn if the combination therapy of panitumumab, pembrolizumab, and standard-of-care chemotherapy can help to control inflammatory breast cancer.

Clinical Trial Description

Primary Objective: • To determine the pathological complete response (pCR rate) of the proposed combination in patients with newly diagnosed triple-negative IBC (TN-IBC) Secondary Objective: - To evaluate the surgical complication rate after the completion of the proposed treatment - To determine the change of EGR1 related to the efficacy of proposed treatment (Key Secondary Objective) - To determine the immunological change of tumor microenvironment (TME) related to the efficacy of proposed treatment (Key Secondary Objective) - To define the cutoff or threshold of changes of EGR1, which will correlate with the pCR. - To define the cutoff or threshold of immunological changes of TME, which will correlate with the pCR. - To determine two-year recurrence-free survival (RFS) rates - To determine two-year overall survival (OS) rates - To determine the safety and tolerability - To determine the predictive biomarkers to predict the therapeutic response (correlative study) ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05177796
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Naoto Ueno, MD
Phone (713) 792-8754
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date June 30, 2022
Completion date December 31, 2028

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