A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER
The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.
Inclusion Criteria:
Exclusion Criteria:
Berazategui, Buenos Aires B1884BBF, Argentina
C.a.b.a, C1050AAK, Argentina
Londrina, Paraná 86015-520, Brazil
Lajeado, Rio Grande do Sul 95900-000, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Florianópolis, Santa Catarina 88034-000, Brazil
Itajaí, Santa Catarina 88301-215, Brazil
Itajaí, Santa Catarina 88301-220, Brazil
Santo André, São Paulo 09060-650, Brazil
Santo André, São Paulo 09060-870, Brazil
V Region, Chile
V Region, Chile
Miskolc, 3526, Hungary
Szolnok, 5000, Hungary
Navi Mumbai, Maharashtra 401210, India
Kitaadachi-gun, Saitama 362-0806, Japan
Bunkyo-ku, Tokyo 113-8677, Japan
Meguro-Ku, Tokyo 152-8902, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Mexico City, Mexico City 06760, Mexico
Olsztyn, 10-228, Poland
Timișoara, 300595, Romania
Ufa, Bashkortostan Republic 450054, Russia
Ufa, Bashkortostan Republic 450054, Russia
Kislino Settlement, Kursk Oblast 305524, Russia
Kuzmolovo, Vsevolozhskiy, Leningradskaya Oblast' 188663, Russia
Saint Petersburg, Pos.pesochny 197758, Russia
Petrozavodsk, Republic of Karelia 185002, Russia
Saransk, Respublika Mordoviya 430032, Russia
Poselok Pesochny, Sankt-Peterburg 197758, Russia
Lermontov, Stavropol Kray 357340, Russia
Pyatigorsk, Stavropol Kray 357502, Russia
Pyatigorsk, Stavropol Kray 357502, Russia
Volzhsky, Volgograd Oblast 404130, Russia
Chelyabinsk, 454087, Russia
Ivanovo, 153040, Russia
Moscow, 115478, Russia
Nizhny Novgorod, 603081, Russia
Oryol, 302020, Russia
Ryazan, 390011, Russia
Saint Petersburg, 195067, Russia
Saint Petersburg, 195271, Russia
Saint Petersburg, 196247, Russia
Saratov, 410004, Russia
Stavropol, 355047, Russia
Joannesburg, Gauteng 2193, South Africa
Pretoria, Gauteng 0002, South Africa
Amphur Muang, Udonthani 41330, Thailand
Chernivtsi, 58013, Ukraine
Dnipro, 49102, Ukraine
Kharkiv, 61024, Ukraine
Kryvyi Rih, 50048, Ukraine
Kyiv, 04107, Ukraine