[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461448":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":54,"centralContacts":58,"locations":65,"responsibleParty":84,"collaborators":63,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":63,"enrollmentInfo":97,"targetDuration":63,"studyType":100,"phases":101,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":67,"whyStopped":63,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14,19,24],{"label":9,"type":6,"description":10,"interventionNames":11},"Her2\u002Fneu positive and lymph node positive","T-DM1\u002F trastuzumab emtansine infusion along with radiation to the breast or chest wall and lymph nodes",[12,13],"Drug: T-DM1","Radiation: External Beam Radiation Therapy 1",{"label":15,"type":6,"description":16,"interventionNames":17},"Her2\u002Fneu positive and lymph node negative","T-DM1\u002Ftrastuzumab emtansine infusion along with radiation to the whole breast or chest wall",[12,18],"Radiation: External Beam Radiation Therapy 0",{"label":20,"type":6,"description":21,"interventionNames":22},"Her2\u002Fneu negative and lymph node positive","oral capecitabine twice per day along with radiation to the breast or chest wall and lymph nodes",[23,13],"Drug: Capecitabine",{"label":25,"type":6,"description":26,"interventionNames":27},"Her2\u002Fneu negative and lymph node negative","oral capecitabine twice per day along with radiation to the whole breast or chest wall",[23,18],[29,36,42,49],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","T-DM1","Dosed at 3.6 mg\u002Fkg of body weight every 3 weeks for Her2\u002Fneu+ patients for a total duration of 14 cycles.",[15,9],[35],"trastuzumab emtansine",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Capecitabine","Dosed at 825 mg\u002Fm2 +\u002F- 150mg twice per day for a total duration of 6 months",[25,20],[41],"xeloda",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"RADIATION","External Beam Radiation Therapy 0","Dose of 40 Gy in 15 fractions to the whole breast or chest wall followed by consideration of a 10 Gy in 4 fraction boost to the lumpectomy cavity for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.",[25,15],[48],"EBRT",{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"External Beam Radiation Therapy 1","Dose of 40 Gy in 15 fractions to either the breast or chest wall along with comprehensive nodal radiation followed by consideration of a 10 Gy in 4 fraction boost for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.",[20,9],[48],[55],{"name":56,"affiliation":5,"role":57},"Einsley Janowski, MD, PhD","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":63,"email":64},"Song Wood","CONTACT","4342430008",null,"stw2g@hscmail.mcc.virginia.edu",[66],{"facility":5,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Charlottesville","Virginia","22903","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-78.47668,38.02931,{"lat":77,"lon":76},[80,82],{"name":60,"role":61,"phone":81,"phoneExt":63,"email":64},"434 243 0008",{"name":83,"role":57,"phone":63,"phoneExt":63,"email":63},"Einsley Janowski, Md, PhD",{"type":57,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"Einsley-Marie Janowski, MD","Assistant Professor","100461448","phase-2-adjuvant-chemoradiation-and-biomarkers-of-response-in-high-risk-breast-cancer-100461448",false,"NCT05288777","Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer","A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer","Breast53","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 or older\n4. Diagnosis of stage I-IIIB breast cancer\n5. Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and\u002For mastectomy)\n6. Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection\n7. Candidate for adjuvant chemoradiation as part of standard clinical care\n8. Planned initiation of radiation within 12 weeks of their final oncologic surgery\n9. ECOG performance status ≤2\n10. Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)\n11. Adequate organ function per the following criteria within 21 days before the start of treatment. If a laboratory value required for study eligibility does not meet the below requirements, the value may be retested.\n\n    * Absolute neutrophil count ≥1.5 k\u002FuL\n    * Platelets ≥100 k\u002FuL\n    * Hemoglobin ≥ 10 g\u002FdL\n    * Serum Creatinine ≤ 1.5 x ULN\n    * Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed).\n    * AST and ALT ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n12. For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 6 months after the end of chemoradiation administration or until advised by their medical oncologist\n13. Agreement to adhere to Lifestyle Considerations throughout study duration\n14. Subjects taking warfarin and plan to receive capecitabine will need their anticoagulant management assessed before starting treatment.\n\nExclusion Criteria:\n\n1. Had a mastectomy with expander placement or immediate reconstructions\n2. Diagnosed with systemic lupus\n3. Diagnosed with scleroderma\n4. Diagnosed with a genetic mutation associated with increased sensitivity to radiation (e.g. ataxia-telangectasias (AT)). AT heterozygotes without known radiation sensitivity may be included.\n5. Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration.\n6. Pathologic evidence of metastatic disease, or strong clinical\u002Fradiological evidence of metastatic disease, at the investigator's judgment.\n7. Pregnancy or lactation\n8. Incarceration\n9. Presence of cardiac pacemaker on side of the body that is being treated unless the pacemaker can be moved prior to treatment.\n10. Anthracycline exposure exceeding a cumulative doxorubicin dose of 264 mg\u002Fm2 (240 mg\u002Fm2 plus a 10% threshold)\n11. Known allergic reactions to components of capecitabine or T-DM1\n12. Known DPD deficiency for patients prescribed capecitabine\n13. Febrile illness within a week of starting treatment\n14. Incomplete healing of chest wall or breast in the treatment field within 12 weeks from surgery.\n15. Known HIV or active hepatitis.\n16. Unwilling to discontinue endocrine therapy if currently taking endocrine therapy.","ALL","18 Years",{"count":98,"type":99},45,"ESTIMATED","INTERVENTIONAL",[102,103],"PHASE2","PHASE3","The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and\u002For mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.",[106,107,108,109],"Breast Cancer","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III",[111,112,113,114,31,41,115,116,117,118],"Radiation","Chemoradiation","Chemotherapy","Chemo","capecitabine","Adjuvant","Combination treatment","trastuzumab","2025-04-15",{"date":121,"type":122},"2025-04-18","ACTUAL",{"date":124,"type":122},"2022-07-11",{"date":126,"type":99},"2029-12",{"name":5,"class":6},1]