Title: A pilot study of changes in PD-L1 expression during preoperative treatment with nab-paclitaxel and pembrolizumab in hormone receptor-positive breast cancer

Principal Investigator: Adrienne G. Waks, MD, of Dana-Farber Cancer Institute 

Description: Researchers are conducting a phase 1 trial to investigate nab-paclitaxel and pembrolizumab as combination treatment for patients with hormone receptor-positive breast cancer.


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In the first arm of the trial, patients will receive 2 weeks of nab-paclitaxel run in, followed by a biopsy. Then, patients will receive weekly nab-paclitaxel and pembrolizumab every 3 weeks for a total of 15 weeks.

In the second arm, patients will receive 2 weeks of pembrolizumab run in, followed by a biopsy. Patients will then receive weekly nab-paclitaxel and pembrolizumab every 3 weeks for a total of 14 weeks.

The primary outcome measure is change in PD-L1 expression from the baseline biopsy to the biopsy at 2 weeks. Secondary outcome measures include adverse events, overall response rate, and disease-free survival.

To be eligible for this study, patients must be 18 years of age or older and have  histologically or cytologically confirmed invasive breast cancer. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Adrienne G. Waks in collaboration with Merck Sharp & Dohme Corp.

Reference

ClinicalTrials.gov. A study of changes in PD-L1 expression during preoperative treatment with nab-paclitaxel and pembrolizumab in hormone receptor-positive breast cancer. NCT02999477. Accessed June 22, 2022.