A phase II, randomized, open-labeled study to evaluate low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer (TNBC).

ABSTRACT:

Background

Breast cancer is the most common malignancy diagnosed in women worldwide. Triple-negative breast cancer (TNBC) is the most aggressive subtype, accounting for nearly one third of all breast cancers in India. The addition of pembrolizumab to neoadjuvant chemotherapy improved the pathological response and event free survival in patients with TNBC. However, for most patients in low- and middle-income countries, immunotherapy remains inaccessible due to its high cost. Pharmacological and early clinical data suggest that a lower dose of pembrolizumab may be effective. However, there are no prospective clinical trials in patients with TNBC.

Methods

This is a single-site phase II, randomized, open-labeled, parallel-group trial. Eligible patients will be randomized (1:1) t

SUBMITTER: Arora A 

PROVIDER: S-EPMC11866667 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature