[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534981":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":42,"studyPopulation":39,"armGroups":43,"interventions":56,"overallOfficials":98,"centralContacts":103,"locations":112,"responsibleParty":140,"collaborators":142,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":39,"enrollmentInfo":155,"targetDuration":39,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":114,"whyStopped":39,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"SULmax in relation to pCR","Evaluate if lack of decrease in fluorodeooxyglucose (FDG) \u002F positron emission tomography (PET) standardized uptake value corrected for lean body mass (SULmax) by \\\u003C40% after 1 cycle of neoadjuvant therapy correlates with residual disease at the time of surgery.","8 months",[14,18],{"measure":15,"description":16,"timeFrame":17},"Pathologic complete response (pCR)","Evaluate the pathologic complete response (pCR) rate in patients with early-stage triple negative breast cancer (TNBC) treated with neoadjuvant chemo-immunotherapy.","3 years",{"measure":19,"description":20,"timeFrame":17},"Circulating tumor deoxyribonucleic acid (ctDNA) clearance","Evaluate how circulating tumor deoxyribonucleic acid (ctDNA) kinetics collected at pre-treatment, and during and after completion of neoadjuvant treatment correlate with pathologic complete response (pCR) at the time of surgery.",[22,25,28,31],{"measure":23,"description":24,"timeFrame":17},"Pathologic complete response (pCR) comparison","Compare the pathologic complete response (pCR) rates among patients who achieved clinical complete response (cCR) by breast magnetic resonance imaging (MRI) and those received \"rescue\" neoadjuvant AC\u002Fpembrolizumab with clinical residual disease (RD) after MRI scan.",{"measure":26,"description":27,"timeFrame":17},"Diagnostic accuracy of percent and absolute change between baseline and C1D15 measurements","Evaluate the diagnostic accuracy of percent and absolute change (between baseline and C1D15 measurements), and C1D15 absolute measurements in fluorodeooxyglucose (FDG) \u002F positron emission tomography (PET) standardized uptake value corrected for lean body mass (SULmax) for predicting clinical complete response (cCR) using receiver operating characteristic (ROC) curve.",{"measure":29,"description":30,"timeFrame":17},"Clinical complete response (cCR) and pathologic complete response (pCR)","Investigate if clinical complete response (cCR) by MRI is predictive of pathologic complete response (pCR).",{"measure":32,"description":33,"timeFrame":17},"Change in microbiome","Number of patients that experienced changes in the microbiome serially over time of residual disease.",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":39,"timePerspective":39,"maskingInfo":40},"NA","SEQUENTIAL","Eligible patients with stage 2 and 3 TNBC (ER\\\u003C10% eligible) will be treated with 4 cycles of paclitaxel\u002Fcarboplatin\u002Fpembrolizumab prior to surgery. A PET scan will be performed at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with RD will complete neoadjuvant rescue with 4 cycles of doxorubicin\u002Fcyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin\u002Fcyclophosphamide\u002Fpembrolizumab, capecitabine etc).","TREATMENT",null,{"masking":41,"maskingDescription":39,"whoMasked":39},"NONE","Eligible participants will undergo baseline procedures including research bloodwork, MRI and PET scan. Participants will then be treated with one cycle of paclitaxel, carboplatin and pembrolizumab (TCarbo\u002Fpembro). At the end of Cycle one patients will undergo repeat procedures (bloodwork and PET scan), and then continue with treatment for an additional three cycles. ctDNA will be collected on day 1 of each cycle. At the end of treatment patients will undergo repeat MRI.\n\nPatients achieving a clinical complete response (CR) on MRI will proceed with surgery. Patients with clinical residual disease (RD) on MRI will be recommended a biopsy, and be recommended \"rescue\" neoadjuvant doxorubicin and cyclophosphamide with pembrolizumab (AC\u002Fpembro) for four additional cycles, and then proceed with surgery. Note: patients\u002Ftreating physician may opt to proceed with surgery.\n\nArchival tissue will be collected from the surgical product. Patients achieving a pathologic CR (pCR) may proceed with adjuvant pembrolizumab per standard of care, and treating physician's discretion. Patients with pathological RD may proceed with \"rescue\" adjuvant AC\u002Fpembrolizumab for four additional cycles (if not given neoadjuvantly), per treating physician discretion. The participants may also receive Aadjuvant capecitabine or olaparib as indicated and per treating physician's discretion.",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Neoadjuvant therapy","EXPERIMENTAL","4 cycles of paclitaxel\u002Fcarboplatin\u002Fpembrolizumab",[49,50,51,52,53,54,55],"Drug: Paclitaxel","Drug: Carboplatin","Drug: Pembrolizumab","Drug: Doxorubicin","Drug: Cyclophosphamide","Drug: Olaparib","Drug: Capecitabine",[57,64,69,75,81,87,93],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DRUG","Paclitaxel","chemotherapy",[45],[63],"Taxol",{"type":58,"name":65,"description":60,"armGroupLabels":66,"otherNames":67},"Carboplatin",[45],[68],"Paraplatin",{"type":58,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Pembrolizumab","immunotherapy",[45],[74],"Keytruda",{"type":58,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Doxorubicin","additional chemotherapy - neoadjuvant or adjuvant rescue",[45],[80],"Adriamycin",{"type":58,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"Cyclophosphamide","additional chemotherapy - adjuvant rescue",[45],[86],"Cytoxan",{"type":58,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"Olaparib","adjuvant rescue",[45],[92],"Lynparza",{"type":58,"name":94,"description":89,"armGroupLabels":95,"otherNames":96},"Capecitabine",[45],[97],"Xeloda",[99],{"name":100,"affiliation":101,"role":102},"Cesar A Santa-Maria, MD","Johns Hopkins University","STUDY_CHAIR",[104,108],{"name":100,"role":105,"phone":106,"phoneExt":39,"email":107},"CONTACT","410-614-0874","csantam2@jhmi.edu",{"name":109,"role":105,"phone":110,"phoneExt":39,"email":111},"Hopkins Breast Trials","410-614-1361","HopkinsBreastTrials@jhmi.edu",[113,131],{"facility":5,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":121,"coordinates":122},"Point",[123,124],-76.61219,39.29038,{"lat":124,"lon":123},[127,128],{"name":109,"role":105,"phone":110,"phoneExt":39,"email":111},{"name":129,"role":130,"phone":39,"phoneExt":39,"email":39},"Cesar A Santa-Maria, M.D.","PRINCIPAL_INVESTIGATOR",{"facility":5,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},{"type":121,"coordinates":133},[123,124],{"lat":124,"lon":123},[136],{"name":137,"role":105,"phone":138,"phoneExt":39,"email":139},"JHCCCRO","410-955-8866","jhcccro@jhmi.edu",{"type":141,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[143],{"name":144,"class":6},"Breast Cancer Research Foundation","100534981","phase-2-pet-dynamics-to-response-adapted-neoadjuvant-therapy-in-tnbc-100534981",false,"NCT06245889","PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC","A Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics","NeoADAPT","Inclusion Criteria:\n\n1. Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible\n2. Age ≥ 18 years\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n4. Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:\n\n   1. Adequate marrow and organ function\n   2. Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications)\n5. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study\n\nExclusion Criteria:\n\n1. Patients unable to undergo PET or MRI\n2. Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)\n3. Inflammatory breast cancer\n4. Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors","FEMALE","18 Years",{"count":156,"type":157},30,"ESTIMATED","INTERVENTIONAL",[160],"PHASE2","Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel\u002Fcarboplatin\u002Fpembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with clinical residual disease will complete neoadjuvant rescue with 4 cycles of doxorubicin\u002Fcyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin\u002Fcyclophosphamide\u002Fpembrolizumab, capecitabine etc).",[163],"Triple Negative Breast Cancer",[165,166,167],"breast cancer","triple negative","neoadjuvant","2026-09-02",{"date":170,"type":171},"2026-09-03","ACTUAL",{"date":173,"type":171},"2024-05-01",{"date":175,"type":157},"2030-06",{"name":5,"class":6},2]