707
Participants
Start Date
February 24, 2014
Primary Completion Date
August 24, 2016
Study Completion Date
June 27, 2020
PF-05280014
Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
Paclitaxel
A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m\^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m\^2 and then 60 mg/m\^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator.
Herceptin®
Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion weekly until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the Herceptin® regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
Paclitaxel
A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m\^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m\^2 and then 60 mg/m\^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator.
Hospital Militar Central, Lima
INNPARES, Lima
Resocentro, Lima
Clinica Anglo Americana, Lima
Instituto de Oncologia y Radioterapia de la Clinica Ricardo Palma, Lima
Radiologos S.R.L., Lima
Instituto Nacional de Enfermedades Neoplasicas, Lima
Siglo XXI, Lima
Manila Doctors Hospital, Manila
University of Philippines Manila-Philippine General Hospital, Manila
Manila Doctors Hospital, Manila
St. Luke's Medical Center, Quezon City
Veterans Memorial Medical Center, Quezon City
Cardinal Santos Medical Center, San Juan City
The Medical City, Pasig
wits Clinical Research, Joannesburg
The Medical Oncology Centre of Rosebank, Johannesburg
Sandton Oncology Centre, Johannesburg
Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias, Miskolc
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont, Szolnok
Bacs-Kiskun Megyei Korhaz, Onkoradiologiai Kozpont, Kecskemét
Cebu Doctors' University Hospital, Cebu City
The Research Institute at Perpetual Succor Hospital, Cebu City
GVI Oncology, Langenhoven Drive Oncology Centre, Port Elizabeth
Cape Town Oncology Trials, Kraaifontein
GVI Rondebosch Oncology Centre-Rondebosch Medical Centre, Rondebosch
Markusovszky Egyetemi Oktatokorhaz, Szombathely
Faculty of Medicine, Chulongkorn University, Medical Oncology Unit, Bangkok
National Cancer Institute, Ratchathewi
National Cancer Centre, Goyang-si
Institute for Oncology and Radiology of Serbia, Belgrade
Military Medical Academy, Belgrade
"General Hospital of Athens Hippokration", Athens
Instituto Nacional de Cancerologia, Mexico City
Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali, Bursa
Clinic of Oncology-Clinical Center Nis, Niš
Municipal Non-profit Enterprise Podilsk Regional Oncology Centre of Vinnytsia Regional Council, Vinnytsia
Dicle University Medical Faculty, Diyarbakır
Oncology Institute of Vojvodina, Kamenitz
Gaziantep University Medical Faculty, Gaziantep
Chungbuk National University Hospital, Cheongju-si
Khmelnytskyi Regional Oncologic Dispensary, Khmelnytskyi
Florida Cancer Research Institute, Plantation
Florida Cancer Research Institute, Boca Raton
Istanbul Universitesi Onkoloji Enstitusu, Istanbul
Udonthani Cancer Hospital, Amphur Muang
Kyungpook National University Chilgok Hospital, Daegu
Ulsan University Hospital, Ulsan
Municipal Non-Profit Enterprise City Clinical Hospital No.4of Dnipro Regional Council, Department of, Dnipro
Pusan National University Hospital, Busan
Municipal Enterprise 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council', Kryvyi Rih
Interbalkan European Medical Center, Pylaia
"Municipal Institution Chernivtsi Regional Clinical Oncology Center, Outpatient Department", Chernivtsi
SI Institute of Medical Radiology n.a.S.P. Ilrygoriev of National Academy of Medical Science of, Kharkiv
"Communal Non-Profit Enterprise Regional Center of Oncology", Kharkiv
Municipal Institution Odesa Regional Clinical Hospital, Mammology Center, Odesa
Oaxaca Site Management Organization S.C., Oaxaca City
"General Hospital of Chania O Agios Georgios", Chania
Cancerologia de Queretaro S.C., Querétaro
Lviv State Oncologic Regional Treatment and Diagnostic Center, Lviv
Zakarpattia Regional Clinical Oncological Center, Uzhhorod
FSBSI Russian Cancer Research Center n.a. N.N.Blokhin, Moscow
"Federal State Budgetary Institution Russian Oncological Scientific Center n.a. N.N. Blokhin of", Moscow
LLC VitaMed, Moscow
LLC VitaMed, Moscow
"Regional Budgetary Healthcare Institution Ivanovo Regional Oncology Dispensary", Ivanovo
GBUZ Arkhangelsk Regional Clinical Oncological dispensary, Arkhangelsk
State Budgetary Healthcare Institution ''Republic Oncological Dispensary'', Petrozavodsk
"State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary", Kuzmolovo, Vsevolozhskiy
"SBI North-Western State Medical University n.a. I. I. Mechnikov of the MoH of the Russian", Saint Petersburg
Non-state healthcare agency Road Clinical Hospital PLC Russian Railways, Saint Petersburg
"Saint-Petersburg State Budgetary Healthcare Institution Oncological Dispensary of Moscow District", Saint Petersburg
Private medical institution Euromedservice, Pushkin
"SBEI of HPE First Saint Petersburg State Medical University", Saint Petersburg
Federal State Budgetary Institution ¿National Medical Research Oncology Centre named after N.N., Saint Petersburg
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology), Poselok Pesochny
Centrul de Oncologie Sf. Nectarie, Craiova
SC Oncolab SRL, Oncologie, Craiova
"SBIH of Kaluga Region Kaluga Regional Clinical Oncology Dispensary", Kaluga
Spitalul Clinic Municipal de Urgenta Timisoara, Sectia Clinica Oncologie Medicala, Timișoara
"Budgetary Institution of Healthcare of Orel region Orel oncological dispensary", Oryol
State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee, Kislino Settlement
Acharya Tulsi Regional Cancer Treatment and Research Institute, Bikaner
Rostov Research Institute of Oncology, Rostov-on-Don
"State Budgetary Healthcare Institution of Stavropol region Stavropol regional clinical oncology", Stavropol
"Federal State Budgetary Healthcare Institution of Clinical Hospital #101 of Federal Medical and", Lermontov
Centre of Specialized kinds of Medical Care of Pyatigorsk city, Pyatigorsk
State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncology Dispensary, Pyatigorsk
LLC Novaya Clinica, Pyatigorsk
Pyatigorsk City Hospital #2, Pyatigorsk
Stavropol Regional Hospital for War Veterans, Pyatigorsk
LLC Medekspert, Kislovodsk
Republic Clinical Hospital of Emergency Care, Grozny
"SBEI HPE RyazSMU of MoH of the Russian Federation based on SBI of Ryazan Region Regional CLinical", Ryazan
Tata Memorial Centre, Tata Memorial Hospital, Mumbai
Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca
S.C. Medisprof S.R.L, Cluj-Napoca
Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Navi Mumbai
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary, Volzhsky
"Non-State Healthcare Institution Road Clinical Hospital at Saratov II Station", Saratov
Sahyadri Clinical Research & Development Centre, Pune
Sahyadri Speciality Hospital, Pune
"State budget institution of healthcare of Mordovia Republic Republic Oncology Dispensary", Saransk
GBUZ Republican Clinical Hospital n.a. G.F. Kuvatova, Ufa
Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Baskortostan Republic, Ufa
State Healthcare Institution, Republican Clinical Oncology Dispensary of the Ministry of, Ufa
"State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Oncological Dispensary", Chelyabinsk
"GBUZ Regional Oncology Dispensary #2", Magnitogorsk
MNJ Institute of Oncology & Regional Cancer Center, Hyderabad
Department of Medicine New Block, Visakhapatnam
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu
Manipal Hospital, Bengaluru
Manipal Centre for Clinical Research, Manipal
"State Budgetary Healthcare Institution Nizhniy Novgorod Regional Oncological Dispensary", Nizhny Novgorod
"GBUZ of Perm region Perm regional oncology dispensary", Perm
Meenakshi Mission Hospital and Research Centre, Madurai
"BIH of Omsk Region Clinical oncological dispensary", Omsk
"Spitalul Judetean de Urgenta Sf.Ioan cel Nou, Sectia Oncologie", Suceava
Acharya Harihar Regional Cancer Center, Cuttack
Hospital Clinico Vina Del Mar, Viña del Mar
Instituto Oncologico, Clinica Renaca, Viña del Mar
Clinica Alemana de Temuco, Temuco
Centro de Investigacion Clinica SIM, Temuco
Administrative office, Temuco
Fresenius Kabi Chile Therapia iv, Santiago
Kumamoto University Hospital, Kumamoto
Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge, Goiânia
Cancer Center of Central Connecticut, Plainville
Cancer Center of Central Connecticut, Southington
COIBA - Centro de Oncologia e Investigacion Buenos Aires, Berazategui
Instituto De Oncologia De Rosario, Rosario
Centro Medico San Roque, San Miguel de Tucumán
Sanatorio de la Providencia, C.a.b.a
CRIO - Centro Regional Integrado de Oncologia, Fortaleza
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba
Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL, Londrina
Associacao Hospital de Caridade Ijui, Ijuí
Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado), Lajeado
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia, Porto Alegre
Centro de Pesquisas Oncologicas de Santa Catarina - CEPON, Florianópolis
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral, Itajaí
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral, Itajaí
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo André
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo André
Hospital Naval Almirante Nef, V Region
Instituto Oncologico Clinica Renaca, V Region
Onkologicka klinika VFN a 1. LF UK, Fakultni poliklinika, Prague
Shatabdi Super Speciality Hospital, Nashik
Deenanath Mangeshkar Hospital & Research Centre, Pune
National Hospital Organization Nagoya Medical Center, Nagoya
National Hospital Organization Kyushu Cancer Center, Fukuoka
Japan Community Health care Organization Kurume General Hospital, Kurume
Hokkaido University Hospital, Sapporo
Saitama Cancer Center Hospital, Kitaadachi-gun
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Bunkyo-ku
National Hospital Organization Tokyo Medical Center, Meguro-Ku
Showa University Hospital, Shinagawa-ku
Chiba Cancer Center, Chiba
Hakuaikai Medical Corporation Sagara Hospital, Kagoshima
Niigata Cancer Center Hospital, Niigata
Nakanoshima Osaka Breast Clinic, Osaka
Osaka Breast Clinic, Osaka
Shizuoka General Hospital, Shizuoka
P.Stradins Clinical University Hospital, Riga
Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica), Mexico City
"Inter Hosp S.A. de C.V. Centro Medico Dalinde", Mexico City
Resocentro, Lima
Siglo XXI, Lima
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii, Gdynia
Centrum Terapii Wspolczesnej, Lodz
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii, Olsztyn
MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie, Rzeszów
Magodent Sp. z o.o. Oddzial Onkologii Klinicznej/Chemioterapii, Warsaw
Hospital de Braga, Braga
Hospital CUF Descobertas, Lisbon
Spitalul Universitar de Urgenta, Departamentul Oncologie Medicala, Bucharest
Onkologicky ustav sv. Alzbety, s.r.o., Bratislava
Narodny Onkologicky Ustav, Bratislava
*Department of Medical Oncology, University of Pretoria & Steve Biko Academic Hospitals Complex, Pretoria
Eastleigh Breast Care Centre, Pretoria
Korea University Anam Hospital, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Korea University Guro Hospital, Seoul
Baskent University School of Medicine Adana Hospital, Adana
Hacettepe Universitesi Tip Fakultesi, Ankara
"Municipal Non-Profit Enterprise of Kyiv Regional Council Kyiv Regional Oncology Dispensary", Kyiv
Lead Sponsor
Pfizer
INDUSTRY