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Cancer Clinical Trials Centre","Sheffield","S10 2SJ",{"type":54,"coordinates":650},[651,652],-1.4659,53.38297,{"lat":652,"lon":651},{"facility":655,"status":40,"city":656,"state":40,"zip":657,"country":596,"countryCode":597,"cosmosGeoPoint":658,"geoPoint":662,"contacts":40},"Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit","Sutton","SM2 5PT",{"type":54,"coordinates":659},[660,661],-0.2,51.35,{"lat":661,"lon":660},{"facility":664,"status":40,"city":665,"state":40,"zip":666,"country":596,"countryCode":597,"cosmosGeoPoint":667,"geoPoint":671,"contacts":40},"Singleton Hospital; Pharmacy","Swansea","SA2 8QA",{"type":54,"coordinates":668},[669,670],-3.94323,51.62079,{"lat":670,"lon":669},{"type":673,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100280013","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-trastuzumab-emtansine-in-combination-with-atezolizumab-or-atezolizumab-placebo-in-participants-with-human-epidermal-growth-factor-2-her2-positive-locally-advanced-or-metastatic-breast-cancer-bc-who-received-prior-trastuzumab-and-taxane-based-therapy-100280013",true,"NCT02924883","A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy","A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy","KATE2","Inclusion Criteria:\n\n* Archival tumor samples must be obtained from primary and\u002For metastatic sites\n* Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression\n* HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of greater than or equal to (\\>=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies\n* Histologically or cytologically confirmed invasive BC: incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic BC\n* Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)\n* Progression must have occurred during or after most recent treatment for locally advanced\u002Fmetastatic BC or within 6 months after completing adjuvant therapy\n* Participants must have measurable disease that is evaluable as per RECIST v1.1\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1\n* Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause\n* Use of highly effective method of contraception as defined by the protocol\n\nExclusion Criteria:\n\n* Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists, anti-programmed death-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents\n* Receipt of any anti-cancer drug\u002Fbiologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria\n* Radiation therapy within 2 weeks prior to Cycle 1, Day 1\n* History of exposure to the cumulative doses of anthracyclines\n* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence\n* Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites\n* Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Current severe, uncontrolled systemic disease\n* Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment\n* Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus\n* Need for current chronic corticosteroid therapy (\\>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)\n* Spinal cord compression not definitively treated with surgery and\u002For radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (\\>) 2 weeks prior to randomization\n* Participants with known central nervous system disease\n* Leptomeningeal disease\n* History of autoimmune disease\n* Prior allogeneic stem cell or solid organ transplantation\n* Active tuberculosis\n* Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study\n* Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization\n* Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial\n* Participants who are breastfeeding, or intending to become pregnant during the study",false,"ALL","18 Years",{"count":686,"type":687},202,"ACTUAL","INTERVENTIONAL",[690],"PHASE2","This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC who have received prior trastuzumab and taxane based therapy, either alone or in combination, and\u002For who have progressed within 6 months after completing adjuvant therapy.",[693],"Metastatic Breast Cancer","COMPLETED","2021-01-28",{"date":697,"type":687},"2021-02-17",{"date":699,"type":687},"2016-09-26",{"date":701,"type":687},"2020-02-06",{"name":5,"class":6},68]