[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440865":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":82,"centralContacts":87,"locations":93,"responsibleParty":120,"collaborators":45,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":45,"enrollmentInfo":133,"targetDuration":45,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":45,"overallStatus":96,"whyStopped":45,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Baylor Breast Care Center","OTHER",[8,18,22,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Triple Negative Breast Cancer (for tumors > 5 cm)","ACTIVE_COMPARATOR","Paclitaxel IV plus carboplatin IV (+\u002F- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+\u002F- pembrolizumab IV) (4 cycles total)",[13,14,15,16,17],"Drug: Paclitaxel","Drug: Carboplatin","Drug: Doxorubicin","Drug: Cyclophosphamide","Drug: Pembrolizumab",{"label":19,"type":10,"description":20,"interventionNames":21},"Triple Negative Breast Cancer (for tumors \u003C 5 cm)","Paclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)",[13,15,16],{"label":23,"type":10,"description":24,"interventionNames":25},"HER2-Positive Breast Cancer","Paclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total)",[13,26,27,15,16,28],"Drug: Trastuzumab","Drug: Pertuzumab","Drug: Pertuzumab\u002FTrastuzumab\u002FHyaluronidase-zzxf",{"label":30,"type":10,"description":31,"interventionNames":32},"Hormone Receptor Positive Breast Cancer","Paclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)",[13,15,16],[34,41,46,52,58,64,70,76],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Paclitaxel","80 mg\u002Fm2 IV administered on Days 1, 8, 15 of each 21-day cycle",[23,30,19,9],[40],"Taxol",{"type":35,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Carboplatin","Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle",[9],null,{"type":35,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Trastuzumab","Trastuzumab 8 mg\u002Fkg loading dose, followed by 6 mg\u002Fkg maintenance dose, administered on Day 1 of each 21-day cycle",[23],[51],"Herceptin",{"type":35,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Pertuzumab","Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle",[23],[57],"Perjeta",{"type":35,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Doxorubicin","60 mg\u002Fm2 IV administered on Day 1 of each 14-day cycle",[23,30,19,9],[63],"Adriamycin",{"type":35,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Cyclophosphamide","600 mg\u002Fm2 IV administered on Day 1 of each 14-day cycle",[23,30,19,9],[69],"Cytoxan",{"type":35,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Pembrolizumab","Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel\u002Fcarboplatin regimen.\n\n400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen.",[9],[75],"Keytruda",{"type":35,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"Pertuzumab\u002FTrastuzumab\u002FHyaluronidase-zzxf","Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab\u002F600 mg trastuzumab\u002F30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab\u002F600 mg trastuzumab\u002F20,000 U hyaluronidase administered subcutaneously every 3 weeks.",[23],[81],"PHESGO",[83],{"name":84,"affiliation":85,"role":86},"Mothaffar Rimawi, MD","Baylor College of Medicine","PRINCIPAL_INVESTIGATOR",[88],{"name":89,"role":90,"phone":91,"phoneExt":45,"email":92},"Maria Rodriguez","CONTACT","(713) 798-8347","bcc-clinicalresearch@bcm.edu",[94,112],{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Harris Health System - Smith Clinic","RECRUITING","Houston","Texas","77054","United States","US",{"type":103,"coordinates":104},"Point",[105,106],-95.36327,29.76328,{"lat":106,"lon":105},[109,111],{"name":89,"role":90,"phone":110,"phoneExt":45,"email":92},"713-798-8347",{"name":84,"role":86,"phone":45,"phoneExt":45,"email":45},{"facility":113,"status":96,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center",{"type":103,"coordinates":115},[105,106],{"lat":106,"lon":105},[118,119],{"name":89,"role":90,"phone":110,"phoneExt":45,"email":92},{"name":84,"role":86,"phone":45,"phoneExt":45,"email":45},{"type":86,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Mothaffar Rimawi","Professor","100440865","phase-2-correlation-of-clinical-response-to-pathologic-response-in-patients-with-early-breast-cancer-100440865",false,"NCT05020860","Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer","A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer","RESPONSE","Inclusion Criteria:\n\n* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.\n* Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).\n\nTo be considered \"high risk,\" at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \\\u003C 6; 4) Ki-67 ≥ 30%.\n\n* Tumors must be at least 2 cm by clinical exam or ultrasound\n* Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.\n* ECOG performance status of 0 or 1\n* Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.\n* Adequate organ function, as determined by the following parameters:\n\n  * Absolute Neutrophil Count (ANC) ≥ 1200\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome\n  * Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN\n  * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN\n  * Serum creatinine ≤ institutional ULN\n* The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.\n* Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of Stage IV disease\n* Inflammatory breast cancer\n* Participants who are pregnant or lactating\n* History of an excisional biopsy or lumpectomy performed prior to study entry\n* Prior treatment with anthracyclines for any malignancy.\n* Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.\n* History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:\n\n  * Angina pectoris requiring the use of anti-anginal medication\n  * Ventricular arrhythmias except for benign premature ventricular contractions\n  * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\n  * Conduction abnormality requiring a pacemaker\n  * Valvular disease with documented compromise in cardiac function\n  * Symptomatic pericarditis\n  * Documented cardiomyopathy\n  * History of documented congestive heart failure (CHF)\n  * Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.\n* Current HIV, hepatitis B, or hepatitis C infection\n* History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.\n* Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.\n* Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.","ALL","18 Years",{"count":134,"type":135},185,"ESTIMATED","INTERVENTIONAL",[138],"PHASE2","The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.",[141,142,143,144,145,146,147,148,149,150,151],"Breast Cancer","Breast Neoplasm","Breast Cancer Female","Breast Cancer Invasive","Breast Cancer Stage II","Breast Cancer Stage III","Triple Negative Breast Cancer","Hormone Receptor-positive Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Neoplasms","Estrogen Receptor-positive Breast Cancer","2025-02-25",{"date":154,"type":155},"2025-02-27","ACTUAL",{"date":157,"type":155},"2023-04-18",{"date":159,"type":135},"2029-11",{"name":5,"class":6},2]