[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438564":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":52,"collaborators":55,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":31,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":31,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":31,"overallStatus":40,"whyStopped":31,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University of Louisville","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Palliative Radiation in Combination with Pembrolizumab","EXPERIMENTAL","Stereotactic radiation therapy will be delivered using either linac-based SBRT using 10x flattening filter-free (FFF) photons or Cyberknife Pencil Beam Technology utilizing 6X photons. Treatment will be delivered in 1-5 fractions. Fractionation and total dose (1500 - 3000 cGy) will depend on the site of disease, previous radiation treatment, and patient symptomatology.\n\nPembrolizumab is supplied as pembrolizumab 100 mg\u002F4 mL vials (25 mg\u002FmL) solution for intravenous infusion. Pembrolizumab at a dose of 200 mg will be administered intravenously every 3 weeks (± 3 days).",[13],"Combination Product: Palliative Radiation and Pembrolizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Palliative Radiation and Pembrolizumab","Stereotactic radiation therapy will be administered as clinically indicated.",[9],[21],"Keytruda",[23],{"name":24,"affiliation":25,"role":26},"Elizabeth Riley, MD","UL Health Brown Cancer Center Deputy Director, Health Affairs","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","502 562-4370",null,"beth.riley@louisville.edu",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Kathleen Coons","502 852-9127","kjcoon01@louisville.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":31},"James Graham Brown Cancer Center","RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-85.75941,38.25424,{"lat":50,"lon":49},{"type":26,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Elizabeth Riley","Principal Investigator",[56],{"name":39,"class":6},"100438564","phase-2-study-of-palliative-radiation-combined-with-pembrolizumab-in-unresectable-metastatic-stage-iv-breast-cancer-100438564",false,"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","Inclusion Criteria:\n\n* 1\\. Subject has provided informed consent\u002Fassent prior to initiation of any study specific activities\u002Fprocedures.\n\n  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\u002Fsoft tissue breast cancer lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by Computer Tomography scan or Magnetic Resonance Imaging. Lymph nodes must measure ≥ 15 mm in their short axis to be considered measurable by Computer Tomography scan or Magnetic Resonance Imaging or Positron Emission Tomography-CT.\n\n  7\\. If subject received major surgery, must have recovered adequately from toxicity and\u002For complications from the intervention prior to enrollment.\n\n  8\\. Subject must have received two prior lines of therapy and include a taxane in the adjuvant\u002Fneoadjuvant or metastatic setting.\n  1. Triple negative breast cancer patients must have received two lines of chemotherapy in the metastatic setting.\n  2. ER+\u002F PR+, ER-\u002FPR+, and ER+\u002FPR- must have received prior Cyclin Dependent Kinase 4\u002F6 Inhibitor in combination with Aromatase Inhibitor or fulvestrant. However, ER+\u002FHer2 overexpressed patients are not required to have received CDK 4\u002F6 inhibitor.\n  3. Her2 overexpressed breast cancer must have had prior trastuzumab\u002Fper (in the neoadjuvant\u002Fadjuvant or metastatic setting, and prior Ado-trastuzumab TDM1 therapy.\n\n     9\\. Adequate organ function determined within 14 days prior to enrollment, defined as follows:\n     * Absolute neutrophil (ANC) \\>1.5 x 109\u002FL\n     * Platelet count\\>50 x 109\u002FL\n     * Hemoglobin\\>8 g\u002FdL\n     * Serum creatinine \\\u003C2.0 x upper limit of normal\n     * Serum bilirubin \\\u003C 2.0 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level \\> 2.0 x ULN\n     * Aspartate aminotransferase (AST) \\\u003C2.5 x ULN OR \\\u003C5 x ULN for subject with liver metastases\n     * Alanine aminotransferase (ALT) \\\u003C2.5 x ULN OR \\\u003C5 x ULN for subject with liver metastases\n     * International normalization ratio (INR) or prothrombin time (PT) \\\u003C1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and partial thromboplastin time (PTT)\u002Factivated PTT (aPTT) is within therapeutic range of intended use of anticoagulants\n     * Lactate dehydrogenase (LDH) levels ≤ 1.5 X upper limit of normal (ULN) within 28 days prior to enrollment\n     * 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.\n     * ECOG performance status of 0, 1 or 2.\n\n     Exclusion Criteria:\n\n  \u003C!-- -->\n\n  1. \\> 4 Clinically active cerebral metastases. Subjects cerebral metastases may be enrolled, provided that there are less than 4 lesions as these may serve as a site of pallative SBRT\n  2. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n  3. Any active autoimmune disease that in the judgement of the PI or sub-I could be significantly worsened by pembrolizumab\n  4. Evidence of clinically significant immunosuppression such as the following:\n\n     * diagnosis of immunodeficiency;\n     * concurrent opportunistic infection;\n     * receiving systemic immunosuppressive therapy (\\> 2 weeks) or within 7 days prior to the first dose of study treatment, including oral steroid doses \\> 20 mg\u002Fday of prednisone or equivalent Subjects that require intermittent use of bronchodilators or local steroid injection will not be excluded from the study.\n  5. Subject has known sensitivity to any of the products or components to be administered during dosing\n  6. Known human immunodeficiency virus (HIV) disease.\n  7. Known acute or chronic hepatitis B or hepatitis C infection.\n  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.\n  9. Has a known history of active Bacillus tuberculosis.\n  10. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n  11. Those patients who would not otherwise have an indication for palliative SBRT\n  12. Prior therapy with tumor vaccine (unless administered in the adjuvant setting).\n  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.\n  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.\n  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\n  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:\n\n      * postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \\\u003C 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\n      * have had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation\u002Focclusion, at least 6 weeks prior to screening; OR\n      * has a congenital or acquired condition that prevents childbearing.\n  17. Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.","FEMALE","18 Years",{"count":67,"type":68},15,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","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",[74],"Metastatic Breast Cancer","2025-02-18",{"date":77,"type":78},"2025-02-20","ACTUAL",{"date":80,"type":78},"2021-09-02",{"date":82,"type":68},"2031-07-01",{"name":5,"class":6},1]