Palliative Radiation and Pembrolizumab for Metastatic Breast Cancer
This study is looking at how well a combination of palliative radiation (radiation therapy to relieve symptoms) and pembrolizumab (a type of immunotherapy) works for women with unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) stage IV breast cancer. You might be able to join if you are at least 18 years old, have been diagnosed with breast cancer, and have already received two other standard treatments. The study aims to see how effective and safe this combination treatment is over three years. The study is currently unclear on its recruitment status and plans to enroll 15 participants.
- Study design
- This is a Phase 2, open-label, single-arm study, meaning all participants will receive the same treatment, and both you and the study team will know what treatment you are getting. It plans to enroll 15 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome measure will be assessed at 3.0 years, suggesting follow-up for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04990921
Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of LouisvilleInvestigator-initiated
~15 participants
Updated 2025-02-20 on ClinicalTrials.gov
What's tested:Palliative Radiation and Pembrolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure
Measured over 3.0 years
Conditions
Where it's being run
1 sites across 1 statesKentucky1
Study leadership
- Elizabeth Riley, MD · PRINCIPAL_INVESTIGATOR · UL Health Brown Cancer Center Deputy Director, Health Affairs
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
1\. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Absolute neutrophil (ANC) \>1.5 x 109/L
Platelet count\>50 x 109/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
Aspartate aminotransferase (AST) \<2.5 x ULN OR \<5 x ULN for subject with liver metastases
Alanine aminotransferase (ALT) \<2.5 x ULN OR \<5 x ULN for subject with liver metastases
International normalization ratio (INR) or prothrombin time (PT) \<1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and partial thromboplastin time (PTT)/activated PTT (aPTT) is within therapeutic range of intended use of anticoagulants
Lactate dehydrogenase (LDH) levels ≤ 1.5 X upper limit of normal (ULN) within 28 days prior to enrollment
Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to enrollment. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
ECOG performance status of 0, 1 or 2.
Exclusion
diagnosis of immunodeficiency;
concurrent opportunistic infection;
receiving systemic immunosuppressive therapy (\> 2 weeks) or within 7 days prior to the first dose of study treatment, including oral steroid doses \> 20 mg/day of prednisone or equivalent Subjects that require intermittent use of bronchodilators or local steroid injection will not be excluded from the study. 5. Subject has known sensitivity to any of the products or components to be administered during dosing 6. Known human immunodeficiency virus (HIV) disease. 7. Known acute or chronic hepatitis B or hepatitis C infection. 8. Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease. 9. Has a known history of active Bacillus tuberculosis. 10. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. 11. Those patients who would not otherwise have an indication for palliative SBRT 12. Prior therapy with tumor vaccine (unless administered in the adjuvant setting). 13. Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study. 14. Expected to require other cancer therapy while on study with the exception of local radiation treatment to the site of bone and other metastasis for palliative pain management. Concurrent endocrine therapy or trastuzumab therapy is allowed if clinically indicated. Concurrent bone modifying agents (including denosumab or zoledronic acid) is allowed for patients with bone metastases. 15. Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment or 4 months after the last dose of pembrolizumab 16. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment or 4 months after the last dose of pembrolizumab, whichever is later. Note: Women not of childbearing potential are defined as:
postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone follicule stimulating hormone \[FSH\] level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.); OR
have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR
has a congenital or acquired condition that prevents childbearing. 17. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
What this trial measures
- Primary Outcome Measure3.0 years
Overall Response Rate (complete response \[CR\]+partial response \[PR\] by investigator assessment using modified RECIST v1.1) at week 24