drugset / Trial / NCT04251169

Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression

NCT04251169 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (hereafter referred to as HR+/HER2-) breast cancer who had recurrence or progression while receiving previous therapy with a cyclin-dependent kinase (CDK) inhibitor in the adjuvant setting or to treat advanced disease (or both).

Timeline

Start
2020-07-21
Primary completion
2024-04-10
Completion
2024-04-30

Outcome

Outcome not reported

Stopped (Enrollment): “The enrollment was stopped prematurely due to the lack of funding”

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications