Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

Summary

The goal of this study is to establish the safety and tolerability of pembrolizumab when administered in combination with either of two chemotherapy regimens (weekly paclitaxel or capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.

Timeline

Start

2016-02-23

Primary completion

2019-08-21

Completion

2026-12

Outcome

Met primary endpoint

paper The trial demonstrates that both regimens meet the pre-specified safety endpoint (paclitaxel: 87%; capecitabine: 100%). PMID 37344474 ↗

Publications

• Page DB, Pucilowska J, Chun B, Kim I, Sanchez K, Moxon N, Mellinger S, Wu Y, Koguchi Y, Conrad V, Redmond WL, Martel M, Sun Z, Campbell MB, Conlin A, Acheson A, Basho R, McAndrew P, El-Masry M, Park D, Bennetts L, Seitz RS, Nielsen TJ, McGregor K, Rajamanickam V, Bernard B, Urba WJ, McArthur HL. A phase Ib trial of pembrolizumab plus paclitaxel or flat-dose capecitabine in 1st/2nd line metastatic triple-negative breast cancer. NPJ Breast Cancer. 2023 Jun 21;9(1):53. doi: 10.1038/s41523-023-00541-2.
• Chun B, Pucilowska J, Chang S, Kim I, Nikitin B, Koguchi Y, Redmond WL, Bernard B, Rajamanickam V, Polaske N, Fields PA, Conrad V, Schmidt M, Urba WJ, Conlin AK, McArthur HL, Page DB. Changes in T-cell subsets and clonal repertoire during chemoimmunotherapy with pembrolizumab and paclitaxel or capecitabine for metastatic triple-negative breast cancer. J Immunother Cancer. 2022 Jan;10(1):e004033. doi: 10.1136/jitc-2021-004033.

Drugs

Indications