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Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:
Phase II Open-label, Single-arm Trial of Neoadjuvant Pembrolizumab With Carboplatin and Paclitaxel in Triple-negative Breast Cancer

Clinical Trial Summary

This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting.

Clinical Trial Description

The cure rate of stage I and II triple-negative breast cancer treated with anthracycline-based chemotherapy is high but comes at the price of substantial toxicity. This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate and immune effects of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06407310
Study type Interventional
Source Tel Aviv Medical Center
Contact Yasmin Leshem, MD, P.hD
Phone +972-3-6972061
Email yasminle@tlvmc.gov.il
Status Not yet recruiting
Phase Phase 2
Start date July 1, 2024
Completion date December 1, 2027
View Details
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