drugset / Trial / NCT05233696

Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC

NCT05233696 ↗

NaSingle-groupOpen-labelTreatment

Summary

Patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.

Timeline

Start
2022-01-04
Primary completion
2022-12-01
Completion
2022-12-01

Outcome

Outcome not reported

Stopped (Enrollment): “Low Accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Nab-paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg —