A Phase 2 Study of Palliative Radiation in Combination with Pembrolizumab in Subjects with Unresectable Metastatic Stage IV Breast Cancer: Twisted Pink
University of Louisville
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
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 p…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. 2\. Female age ≥ 18 years at the time of informed consent. 3. Histologically confirmed diagnosis of breast cancer. 4. Disease stage: unresectable or metastatic stage IV breast cancer. 5. Candidate for palliative SBRT independent from study enrollment 6. Measurable disease, defined as at least 1 visceral or nodal/soft tissue breast cancer lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 m…
Interventions
- Combination ProductPalliative Radiation and Pembrolizumab
Stereotactic radiation therapy will be administered as clinically indicated.
Location
- James Graham Brown Cancer CenterLouisville, Kentucky