226
Participants
Start Date
September 23, 2014
Primary Completion Date
March 9, 2016
Study Completion Date
March 9, 2016
PF-05280014
Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles.
Taxotere®
Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Paraplatin®
Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Trastuzumab-EU
Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles.
Taxotere®
Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Paraplatin®
Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz. Belgyogyaszati Klinika Onkologiai Reszleg, Budapest
Szent Imre Egyetemi Oktato Korhaz, Budapest
Uzsoki Utcai Korhaz, Onkoradiologia, Sugarterapia Fovarosi Onkoradiologiai Kozpont, Budapest
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktatokorhaz,, Miskolc
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Szolnok
Bacs-Kiskun Megyei Korhaz, Kecskemét
Institute For Oncology And Radiology Of Serbia, Belgrade
Municipal Healthcare Institution 'Chernihiv Regional Oncology Dispensary', Mamology Department, Chernihiv
Division of Medical Senology, Milan
Vinnytsia Regional Oncology Clinical Dispensary, Chemotherapy Department, Vinnytsia
Khmelnytskyi Regional Oncologic Dispensary, Khmelnytskyi
"Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary, Thoracic Department", Sumy
MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;, Dnipropetrovsk
MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council', Kryvyi Rih
"SI Institute of Medical Radiology n.a.S.P. Hrygoriev of National Academy", Kharkiv
"Munincipal Healthcare InstitutionKharkiv Regional Clinical Oncologic Center", Kharkiv
Municipal Institution 'Odesa Regional Clinical Hospital', Mamology Center, Odesa
Millennium Oncology (Imaging Facility), Kingwood
Millennium Oncology (Imaging Facility), Shenandoah
Millennium Oncology, Shenandoah
Lviv State Oncologic Regional Treatment and Diagnostic Center, Lviv
Compassionate Cancer Care Medical Group, Inc., Fountain Valley
"FSBI Russian Oncology Scientific center n.a. N. N. Blokhin RAMS", Moscow
State Budgetary Institution Of Healthcare, Moscow
"SRBHI Regional Clinical Oncology Dispensary", Veliky Novgorod
"State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary", Kuzmolovo
"State Budgetary Educational Institution of Higher Professional Education North-Western State", Saint Petersburg
Saint-Peterbsurg Clinical Oncological dispensary of Moscow district, Saint Petersburg
"Saint-Petersburg State Budgetary Healthcare Institution Oncological Dispensary of Moscow District", Saint Petersburg
LLC RAMSAY Diagnostic RUS, Saint Petersburg
"Federal State Institution Scientific Research Institute of Oncology n.a. N.N.Petrov", Saint Petersburg
"Saint-Petersburg State Budgetary Institution of healthcare City Clinical Oncological Dispensary", Saint Petersburg
SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov', Lyasny
Regional Budgetary Healthcare Institution, Kursk
"Regional Budgetary Healthcare Institution Kursk regional clinical oncological Dispensary", Kislino Settlement
"State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncological Dispensary", Pyatigorsk
"State Budgetary Healthcare Institution Volgograd Regional Oncological Dispensary #3", Volzhsky
"State Budgetary Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry", Ufa
"SBHI of NNR Clinical diagnostic center", Nizhny Novgorod
"State Budgetary Healthcare Institution of NNR Nizhniy Novgorod Regional Oncological Dispensary", Nizhny Novgorod
"Budgetary Institution of healthcare of Omsk region Clinical oncological dispensary", Omsk
"SBHI Regional Oncology Dispensary", Irkutsk
Fakultni nemocnice Hradec Kralove, Hradec Králové
Divisione di Oncologia Medica B, Roma
IRCCS Istituto Nazionale Tumori Regina Elena (IRE), Roma
Dept. of Surgery, Roma
Szpitale Wojewodzkie w Gdyni Sp. z o.o., Oddzial Onkoligii i Radioterapii, Gdynia
Oddzial Chorob Rozrostowych, Lodz
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn
Onkologicky ustav sv. Alzbety, s.r.o., Bratislava
Narodny Onkologicky ustav, Bratislava
Vychodoslovensky onkologicky ustav, a.s., Košice
Lead Sponsor
Pfizer
INDUSTRY