A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Summary

This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for hormone receptor positive breast cancer. The interventions involved in this study are: * Pembrolizumab (MK-3475; Keytruda™) * Nab-Paclitaxel (Abraxane

Timeline

Start

2017-02-23

Primary completion

2022-11-20

Completion

2026-01-08

Outcome

Missed primary endpoint

paper No significant change in PD-L1 expression occurred following nab-paclitaxel or pembrolizumab run-in, thus the primary endpoint was not met. PMID 41315271 ↗

Publications

• Results Fu J, Waks AG, Pimenta E, Titchen B, Bi K, Camp S, Pappa T, Keenan T, Shannon E, Vigneau S, Bemus M, Nag A, Thorner AR, Park J, DiLullo M, Wrabel E, Jeselsohn R, Mittendorf EA, Abravanel DL, Tolaney SM, Van Allen EM. Cellular reprogramming during anti-PD-1 and chemotherapy treatment in early-stage primary hormone receptor-positive breast cancer. Nat Commun. 2025 Nov 28;16(1):10704. doi: 10.1038/s41467-025-66659-y.
• Results Waks AG, Fu J, Chu X, Binboga Kurt B, Li T, Kuntz TM, Shen Y, Yang D, Meli K, Reardon B, Park J, Partridge A, Abravanel D, Jeselsohn R, Wrabel E, Alberti J, DiLullo M, Chen S, Mohammed-Abreu A, Sun X, Balko JM, Kleijn M, Audeh W, Morgan XC, Krop IE, Tayob N, Van Allen EM, Mittendorf EA, Tolaney SM. Efficacy, safety, and predictive biomarkers of neoadjuvant nab-paclitaxel and pembrolizumab in hormone receptor-positive breast cancer: A randomized pilot trial. Nat Commun. 2025 Nov 28;16(1):10705. doi: 10.1038/s41467-025-66667-y.

Drugs

Indications