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Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

Clinical Trial Summary

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.

Clinical Trial Description

Primary Objective To estimate the rate of pCR in patients with cT1b and T1cN0M0 TNBC after neoadjuvant therapy with 4 cycles of Pembrolizumab + Carboplatin + Paclitaxel. Secondary Objective To assess the safety and toxicity profile of pembrolizumab plus chemotherapy in participants receiving an anthracycline-de-escalated regimen of carboplatin, paclitaxel and pembrolizumab by recording the incidence of treatment emergent adverse events. Exploratory Objectives 1. To estimate the invasive disease-free survival (iDFS), and overall survival (OS) in participants with cT1b-T1cN0 TNBC that receive neoadjuvant pembrolizumab plus chemotherapy in the setting of an anthracycline de-escalation study. 2. To explore if there is a molecular signature associated with response or lack of response to therapy. 3. To evaluate patient reported outcomes of participants receiving this de-escalated regimen. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06318897
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Oluchi Oke, MD
Phone (832) 729-8362
Email oukaegbu@mdanderson.org
Status Recruiting
Phase Phase 2
Start date May 29, 2024
Completion date September 30, 2027
View Details
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