[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100108707":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":48,"locations":48,"responsibleParty":49,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":48,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":48,"enrollmentInfo":61,"targetDuration":48,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":83,"whyStopped":48,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":48},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trastuzumab emtansine","EXPERIMENTAL","Patients received trastuzumab emtansine 3.6 mg\u002Fkg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.",[13],"Drug: Trastuzumab emtansine [Kadcyla]",{"label":15,"type":16,"description":17,"interventionNames":18},"Trastuzumab + docetaxel","ACTIVE_COMPARATOR","Patients received a loading dose of trastuzumab 8 mg\u002Fkg IV + docetaxel 75 or 100 mg\u002Fm\\^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg\u002Fkg IV + docetaxel 75 or 100 mg\u002Fm\\^2 IV on Day 1 of all subsequent 21-day cycles.",[19,20],"Drug: Trastuzumab","Drug: Docetaxel",[22,31,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Trastuzumab emtansine [Kadcyla]","The total dose depended on the patient's weight on Day 1 of each cycle. Trastuzumab emtansine was administered every 3 weeks until investigator-assessed radiographic or clinical progressive disease (or until second disease progression for patients who crossed over), unacceptable toxicity, or study closure, whichever occurred first.",[9],[28,29,30],"trastuzumab-DM1","trastuzumab-MCC-DM1","T-DM1",{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Trastuzumab","The dose of trastuzumab was recalculated if body weight changed by more than ±10% from baseline. Trastuzumab was administered every 3 weeks until investigator-assessed radiographic or clinical progressive disease, or unmanageable toxicity. Patients in the trastuzumab + docetaxel arm who discontinued study treatment because of progressive disease were eligible to cross-over to trastuzumab emtansine treatment until a second progressive disease event, clinical deterioration, and\u002For intolerance.",[15],[36],"Herceptin",{"type":23,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Docetaxel","Docetaxel was given at a dose of 75 or 100 mg\u002Fm\\^2 based on the investigator's decision. Patients in the trastuzumab + docetaxel arm who discontinued study treatment because of progressive disease were eligible to cross-over to trastuzumab emtansine treatment until a second progressive disease event, clinical deterioration, and\u002For intolerance.",[15],[42],"Taxotere",[44],{"name":45,"affiliation":46,"role":47},"Ellie Guardino, MD\u002FPhD","Genentech, Inc.","STUDY_DIRECTOR",null,{"type":50,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100108707","phase-2-a-study-of-the-efficacy-and-safety-of-trastuzumab-emtansine-trastuzumab-mcc-dm1-vs-trastuzumab-herceptin-and-docetaxel-taxotere-in-patients-with-metastatic-her2-positive-breast-cancer-who-have-not-received-prior-chemotherapy-for-metastatic-disease-100108707",true,"NCT00679341","A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease","A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy.\n* Human epidermal growth factor receptor 2 (HER2)-positive.\n* No prior chemotherapy for their metastatic breast cancer (MBC).\n* Measurable disease.\n* Age ≥ 18 years.\n* For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and\u002For partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.\n\nExclusion Criteria:\n\n* History of any chemotherapy for MBC.\n* An interval of \\\u003C 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.\n* Trastuzumab ≤ 21 days prior to randomization.\n* Hormone therapy \\\u003C 7 days prior to randomization.\n* Current peripheral neuropathy of Grade ≥ 3.\n* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.\n* Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.\n* Brain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization.\n* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin \\> 500 mg\u002Fm\\^2; epirubicin \\> 900 mg\u002Fm\\^2; mitoxantrone \\> 120mg\u002Fm\\^2 and idarubicin \\> 90 mg\u002Fm\\^2.\n* Current unstable angina.\n* History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment.\n* History of myocardial infarction within 6 months prior to randomization.\n* Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization.\n* History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment.\n* Cardiac troponin I ≥ 0.2 ng\u002FmL within 28 days of randomization.\n* Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy.\n* Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).\n* Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.\n* Current pregnancy or lactation.\n* History of receiving any investigational treatment within approximately 28 days prior to randomization.\n* Current known infection with human immunodeficiency virus (HIV), active hepatitis B and\u002For hepatitis C virus.\n* History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel.\n* Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80.\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.",false,"ALL","18 Years",{"count":62,"type":63},137,"ACTUAL","INTERVENTIONAL",[66],"PHASE2","This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and\u002For metastatic breast cancer who have not received prior chemotherapy for metastatic disease.",[69],"Breast Cancer",[71,72,36,42,73,74,75,76,77,78,79,80,81,9,82],"HER2-positive breast cancer","HER2","MBC","Breast cancer","TDM1","TDM-1","HER2-positive","HER2+","HER2 positive breast cancer","HER2+ breast cancer","Armed Herceptin","Trastuzumab DM1","COMPLETED","2013-12-09",{"date":86,"type":87},"2014-01-09","ESTIMATED",{"date":89,"type":48},"2008-09",{"date":91,"type":63},"2012-05",{"name":5,"class":6}]