OncoMatch/Clinical Trials/NCT04990921
Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer
Is NCT04990921 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Palliative Radiation and Pembrolizumab for metastatic breast cancer.
Treatment: Palliative Radiation and Pembrolizumab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: taxane — adjuvant/neoadjuvant or metastatic
must have received two prior lines of therapy and include a taxane in the adjuvant/neoadjuvant or metastatic setting
Must have received: chemotherapy — metastatic
Triple negative breast cancer patients must have received two lines of chemotherapy in the metastatic setting
Must have received: CDK4/6 inhibitor
ER+/ PR+, ER-/PR+, and ER+/PR- must have received prior Cyclin Dependent Kinase 4/6 Inhibitor in combination with Aromatase Inhibitor or fulvestrant
Must have received: aromatase inhibitor
ER+/ PR+, ER-/PR+, and ER+/PR- must have received prior Cyclin Dependent Kinase 4/6 Inhibitor in combination with Aromatase Inhibitor or fulvestrant
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab) — neoadjuvant/adjuvant or metastatic
Her2 overexpressed breast cancer must have had prior trastuzumab/per (in the neoadjuvant/adjuvant or metastatic setting, and prior Ado-trastuzumab TDM1 therapy
Must have received: HER2-targeted therapy (ado-trastuzumab emtansine)
prior Ado-trastuzumab TDM1 therapy
Cannot have received: tumor vaccine
Exception: unless administered in the adjuvant setting
Prior therapy with tumor vaccine (unless administered in the adjuvant setting)
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: if within the last 5 years
Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years
Lab requirements
Blood counts
Absolute neutrophil (ANC) >1.5 x 10^9/L; Platelet count>50 x 10^9/L; Hemoglobin>8 g/dL; INR or PT <1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and PTT/aPTT is within therapeutic range of intended use of anticoagulants; LDH levels ≤ 1.5 X ULN within 28 days prior to enrollment
Kidney function
Serum creatinine <2.0 x upper limit of normal
Liver function
Serum bilirubin < 2.0 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 2.0 x ULN; AST <2.5 x ULN OR <5 x ULN for subject with liver metastases; ALT <2.5 x ULN OR <5 x ULN for subject with liver metastases
Adequate organ function determined within 14 days prior to enrollment, defined as follows: Absolute neutrophil (ANC) >1.5 x 10^9/L; Platelet count>50 x 10^9/L; Hemoglobin>8 g/dL; Serum creatinine <2.0 x upper limit of normal; Serum bilirubin < 2.0 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 2.0 x ULN; AST <2.5 x ULN OR <5 x ULN for subject with liver metastases; ALT <2.5 x ULN OR <5 x ULN for subject with liver metastases; INR or PT <1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and PTT/aPTT is within therapeutic range of intended use of anticoagulants; LDH levels ≤ 1.5 X ULN within 28 days prior to enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- James Graham Brown Cancer Center · Louisville, Kentucky
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