NCT04990921

Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer

A Phase 2 Study of Palliative Radiation in Combination with Pembrolizumab in Subjects with Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) in combination with pembrolizumab following disease progression after two prior lines of standard therapy in unresectable metastatic stage IV breast cancer

Detailed description

This study will enroll subjects who are female aged \> 18 years at the time of informed consent with histologically confirmed diagnosis of breast cancer (unresectable or metastatic stage IV breast cancer). Subjects must have measurable disease and be a candidate for palliative stereotactic body radiation therapy (SBRT). Subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2 and adequate hematologic, hepatic, renal, and coagulation function. Subject must also have received two prior lines of FDA-approved therapy. Triple negative patients must have had prior exposure to taxane therapy either in the neoadjuvant/adjuvant or metastatic setting. ER + positive patients must have had prior cyclin dependent kinase (CDK) 4/6 inhibitor therapy. Her2 overexpressed patients must have had prior therapy with trastuzumab and ado-trastuzumab (TDM-1).

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Palliative Radiation and Pembrolizumab	Stereotactic radiation therapy will be administered as clinically indicated.

Timeline

• Start date: 2021-09-02
• Primary completion: 2031-07-01
• Completion: 2031-07-01
• First posted: 2021-08-05
• Last updated: 2025-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study