Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: A randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 317, Issue 1, 2017, Pages 37-47

  Rugo, Hope S ^a   Barve, Abhijit ^b,c   Waller, Cornelius F ^d   Hernandez Bronchud, Miguel ^e   Herson, Jay ^f   Yuan, Jinyu ^c   Sharma, Rajiv ^c   Baczkowski, Mark ^c   Kothekar, Mudgal ^b   Loganathan, Subramanian ^b   Manikhas, Alexey ^g   Bondarenko, Igor ^h   Mukhametshina, Guzel ⁱ   Nemsadze, Gia ^j   Parra, Joseph D ^k   Abesamis Tiambeng, Maria Luisa T ^l   Baramidze, Kakhaber ^m   Akewanlop, Charuwan ⁿ   Vynnychenko, Ihor ^o   Sriuranpong, Virote ^p   Mamillapalli, Gopichand ^q   Ray, Sirshendu ^r   Yanez Ruiz, Eduardo P ^s   Pennella, Eduardo ^c   more..

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Molecular Characterization Analytical Group   (India)

^c Formulation Development Services   (India)

^d UNIVERSITY OF FREIBURG   (Germany)

^e Hip Unit   (Spain)

^f JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^g City Clinical Oncology Dispensary   (Russian Federation)

^h Dnipropetrovsk State Medical Academy   (Ukraine)

ⁱ Russian Federation   (Russian Federation)

^j Institute of Clinical Oncology   (Georgia)

^k Institute of Urology   (Philippines)

^l Cardinal Santos Medical Center   (Philippines)

^m Golden Fleece 21 Century Health House Ltd   (Georgia)

ⁿ MAHIDOL UNIVERSITY   (Thailand)

^o SUMY STATE UNIVERSITY   (Ukraine)

^p CHULALONGKORN UNIVERSITY   (Thailand)

^q City Cancer Center   (India)

^r Curie Manavata Cancer Centre   (India)

^s Institute Clinico Oncológico del Sur ICOS   (Chile)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PACLITAXEL; TRASTUZUMAB; ANTINEOPLASTIC AGENT; BIOSIMILAR AGENT; ERBB2 PROTEIN, HUMAN; TAXOID;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BONE PAIN; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; FEVER; HEADACHE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERGLYCEMIA; IMMUNOGENICITY; INFUSION RELATED REACTION; LEUKOPENIA; MAJOR CLINICAL STUDY; METASTATIC BREAST CANCER; MINIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL DISEASE; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SURVIVAL TIME; TREATMENT DURATION; URINARY TRACT INFECTION; VOMITING; BREAST NEOPLASMS; CHEMISTRY; CLINICAL TRIAL; EQUIPOISE; IMMUNOLOGY; INTENTION TO TREAT ANALYSIS; MIDDLE AGED; MORTALITY; PATHOLOGY; REMISSION; SURVIVAL ANALYSIS; TIME FACTOR; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOSIMILAR PHARMACEUTICALS; BREAST NEOPLASMS; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; MIDDLE AGED; PACLITAXEL; RECEPTOR, ERBB-2; REMISSION INDUCTION; SURVIVAL ANALYSIS; TAXOIDS; THERAPEUTIC EQUIPOISE; TIME FACTORS; TRASTUZUMAB;

EID: 85008395149     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2016.18305     Document Type: Article

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