Spots Global Cancer Trial Database for A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
Official Title: 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
Study ID: NCT01989676
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Cancer Center of Central Connecticut, Plainville, Connecticut, United States
Cancer Center of Central Connecticut, Southington, Connecticut, United States
Florida Cancer Research Institute, Boca Raton, Florida, United States
Florida Cancer Research Institute, Plantation, Florida, United States
COIBA - Centro de Oncologia e Investigacion Buenos Aires, Berazategui, Buenos Aires, Argentina
Instituto De Oncologia De Rosario, Rosario, Santa FE, Argentina
Centro Medico San Roque, San Miguel de Tucuman, Tucuman, Argentina
Sanatorio de la Providencia, C.a.b.a, , Argentina
CRIO - Centro Regional Integrado de Oncologia, Fortaleza, CE, Brazil
Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge, Goiania, GO, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba, Parana, Brazil
Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL, Londrina, Parana, Brazil
Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado), Lajeado, RIO Grande DO SUL, Brazil
Associacao Hospital de Caridade Ijui, Ijui, RS, Brazil
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia, Porto Alegre, RS, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral, Itajai, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, SAO Paulo, Brazil
Centro de Pesquisas Oncologicas de Santa Catarina - CEPON, Florianopolis, SC, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral, Itajai, SC, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo Andre, SP, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo Andre, SP, Brazil
Clinica Alemana de Temuco, Temuco, Region DE LA Araucania, Chile
Centro de Investigacion Clinica SIM, Temuco, Region DE LA Araucania, Chile
Administrative office, Temuco, Region DE LA Araucania, Chile
Fresenius Kabi Chile Therapia iv, Santiago, RM, Chile
Hospital Clinico Vina Del Mar, Vina del Mar, V Region, Chile
Instituto Oncologico, Clinica Renaca, Vina del Mar, V Region, Chile
Hospital Naval Almirante Nef, V Region, , Chile
Instituto Oncologico Clinica Renaca, V Region, , Chile
Onkologicka klinika VFN a 1. LF UK, Fakultni poliklinika, Praha 2, , Czechia
General Hospital of Chania "O Agios Georgios", Chania, Crete, Greece
Interbalkan European Medical Center, Pylaia, Thessaloniki, Greece
General Hospital of Athens "Hippokration", Athens, , Greece
Bacs-Kiskun Megyei Korhaz, Onkoradiologiai Kozpont, Kecskemet, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias, Miskolc, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont, Szolnok, , Hungary
Markusovszky Egyetemi Oktatokorhaz, Szombathely, , Hungary
Department of Medicine New Block, Visakhapatnam, Andhra Pradesh, India
Manipal Hospital, Bengaluru, Karnataka, India
Manipal Centre for Clinical Research, Manipal, Karnataka, India
Tata Memorial Centre, Tata Memorial Hospital, Mumbai, Maharashtra, India
Shatabdi Super Speciality Hospital, Nashik, Maharashtra, India
Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Navi Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, India
Sahyadri Clinical Research & Development Centre, Pune, Maharashtra, India
Sahyadri Speciality Hospital, Pune, Maharashtra, India
Acharya Harihar Regional Cancer Center, Cuttack, Odisha, India
Acharya Tulsi Regional Cancer Treatment and Research Institute, Bikaner, Rajasthan, India
Meenakshi Mission Hospital and Research Centre, Madurai, Tamil NADU, India
MNJ Institute of Oncology & Regional Cancer Center, Hyderabad, Telangana, India
National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-Shi, Fukuoka, Japan
Japan Community Health care Organization Kurume General Hospital, Kurume-city, Fukuoka, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kumamoto University Hospital, Kumamoto-city, Kumamoto, Japan
Saitama Cancer Center Hospital, Kitaadachi-gun, Saitama, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center, Meguro-Ku, Tokyo, Japan
Showa University Hospital, Shinagawa-ku, Tokyo, Japan
Chiba Cancer Center, Chiba, , Japan
Hakuaikai Medical Corporation Sagara Hospital, Kagoshima, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Nakanoshima Osaka Breast Clinic, Osaka, , Japan
Osaka Breast Clinic, Osaka, , Japan
Shizuoka General Hospital, Shizuoka, , Japan
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Ulsan University Hospital, Ulsan, Korea, Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Centre, Goyang-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
P.Stradins Clinical University Hospital, Riga, , Latvia
Instituto Nacional de Cancerologia, Mexico City, Distrito Federal, Mexico
Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica), Mexico, Distrito Federal, Mexico
Inter Hosp S.A. de C.V. "Centro Medico Dalinde", Mexico, Distrito Federal, Mexico
Oaxaca Site Management Organization S.C., Oaxaca, , Mexico
Cancerologia de Queretaro S.C., Queretaro, , Mexico
Hospital Militar Central, Lima, , Peru
INNPARES, Lima, , Peru
Resocentro, Lima, , Peru
Clinica Anglo Americana, Lima, , Peru
Instituto de Oncologia y Radioterapia de la Clinica Ricardo Palma, Lima, , Peru
Radiologos S.R.L., Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Siglo XXI, Lima, , Peru
Resocentro, Lima, , Peru
Siglo XXI, Lima, , Peru
Cebu Doctors' University Hospital, Cebu City, Cebu, Philippines
Cardinal Santos Medical Center, San Juan City, Mentro Manila, Philippines
Manila Doctors Hospital, Manila, Metro Manila, Philippines
Veterans Memorial Medical Center, Quezon City, Metro Manila, Philippines
University of Philippines Manila-Philippine General Hospital, Manila, NCR, Philippines
The Medical City, Pasig City, NCR, Philippines
St. Luke's Medical Center, Quezon City, NCR, Philippines
The Research Institute at Perpetual Succor Hospital, Cebu City, Region VII, Philippines
Manila Doctors Hospital, Manila, , Philippines
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk, , Poland
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii, Gdynia, , Poland
Centrum Terapii Wspolczesnej, Lodz, , Poland
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii, Olsztyn, , Poland
MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie, Rzeszow, , Poland
Magodent Sp. z o.o. Oddzial Onkologii Klinicznej/Chemioterapii, Warszawa, , Poland
Hospital de Braga, Braga, , Portugal
Hospital CUF Descobertas, Lisboa, , Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca, Cluj, Romania
S.C. Medisprof S.R.L, Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sf. Nectarie, Craiova, Dolj, Romania
SC Oncolab SRL, Oncologie, Craiova, Jud Dolj, Romania
Spitalul Universitar de Urgenta, Departamentul Oncologie Medicala, Bucuresti, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu, , Romania
Spitalul Judetean de Urgenta "Sf.Ioan cel Nou", Sectia Oncologie, Suceava, , Romania
Spitalul Clinic Municipal de Urgenta Timisoara, Sectia Clinica Oncologie Medicala, Timisoara, , Romania
Republic Clinical Hospital of Emergency Care, Grozny, Chechenkaya Republic, Russian Federation
State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee, Kislino Settlement, Kursk, Russian Federation
State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary", Kuzmolovo, Vsevolozhskiy, Leningrad Region, Russian Federation
FSBSI Russian Cancer Research Center n.a. N.N.Blokhin, Moscow, NAP, Russian Federation
GBUZ of Perm region "Perm regional oncology dispensary", Perm, NAP, Russian Federation
Federal State Budgetary Institution ¿National Medical Research Oncology Centre named after N.N., Saint-Petersburg, Pos.pesochny, Russian Federation
State Healthcare Institution, Republican Clinical Oncology Dispensary of the Ministry of, Ufa, Republic OF Bashkortostan, Russian Federation
GBUZ Republican Clinical Hospital n.a. G.F. Kuvatova, Ufa, Republic OF Baskortostan, Russian Federation
Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Baskortostan Republic, Ufa, Republic OF Baskortostan, Russian Federation
State Budgetary Healthcare Institution ''Republic Oncological Dispensary'', Petrozavodsk, Republic OF Karelia, Russian Federation
State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary", Saransk, Republic OF Mordovia, Russian Federation
Rostov Research Institute of Oncology, Rostov-on-Don, Rostov Region, Russian Federation
Private medical institution Euromedservice, Pushkin, Saint Petersburg, Russian Federation
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology), Poselok Pesochny, Saint-petersburg, Russian Federation
LLC Medekspert, Kislovodsk, Stavropol Region, Russian Federation
Federal State Budgetary Healthcare Institution of "Clinical Hospital #101 of Federal Medical and, Lermontov, Stavropol Region, Russian Federation
Centre of Specialized kinds of Medical Care of Pyatigorsk city, Pyatigorsk, Stavropol Region, Russian Federation
State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncology Dispensary, Pyatigorsk, Stavropol Region, Russian Federation
LLC Novaya Clinica, Pyatigorsk, Stavropol Region, Russian Federation
Pyatigorsk City Hospital #2, Pyatigorsk, Stavropol Region, Russian Federation
Stavropol Regional Hospital for War Veterans, Pyatigorsk, Stavropol Region, Russian Federation
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary, Volzhskiy, Volgograd Region, Russian Federation
GBUZ Arkhangelsk Regional Clinical Oncological dispensary, Arkhangelsk, , Russian Federation
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary", Chelyabinsk, , Russian Federation
"Regional Budgetary Healthcare Institution ""Ivanovo Regional Oncology Dispensary""", Ivanovo, , Russian Federation
SBIH of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary", Kaluga, , Russian Federation
GBUZ "Regional Oncology Dispensary #2", Magnitogorsk, , Russian Federation
Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N. Blokhin" of, Moscow, , Russian Federation
LLC VitaMed, Moscow, , Russian Federation
LLC VitaMed, Moscow, , Russian Federation
State Budgetary Healthcare Institution "Nizhniy Novgorod Regional Oncological Dispensary", Nizhniy Novgorod, , Russian Federation
"BIH of Omsk Region ""Clinical oncological dispensary""", Omsk, , Russian Federation
Budgetary Institution of Healthcare of Orel region "Orel oncological dispensary", Orel, , Russian Federation
SBEI HPE RyazSMU of MoH of the Russian Federation based on SBI of Ryazan Region "Regional CLinical, Ryazan, , Russian Federation
SBEI of HPE "First Saint Petersburg State Medical University, Saint Petersburg, , Russian Federation
SBI "North-Western State Medical University n.a. I. I. Mechnikov" of the MoH of the Russian, Saint-Petersburg, , Russian Federation
Non-state healthcare agency Road Clinical Hospital PLC Russian Railways, Saint-Petersburg, , Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District", Saint-Petersburg, , Russian Federation
Non-State Healthcare Institution "Road Clinical Hospital at Saratov II Station", Saratov, , Russian Federation
State Budgetary Healthcare Institution of Stavropol region "Stavropol regional clinical oncology, Stavropol, , Russian Federation
Institute for Oncology and Radiology of Serbia, Belgrade, , Serbia
Military Medical Academy, Belgrade, , Serbia
Clinic of Oncology-Clinical Center Nis, Nis, , Serbia
Oncology Institute of Vojvodina, Sremska Kamenica, , Serbia
Onkologicky ustav sv. Alzbety, s.r.o., Bratislava, , Slovakia
Narodny Onkologicky Ustav, Bratislava, , Slovakia
GVI Oncology, Langenhoven Drive Oncology Centre, Port Elizabeth, Eastern CAPE, South Africa
wits Clinical Research, Joannesburg, Gauteng, South Africa
The Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Sandton Oncology Centre, Johannesburg, Gauteng, South Africa
*Department of Medical Oncology, University of Pretoria & Steve Biko Academic Hospitals Complex, Pretoria, Gauteng, South Africa
Eastleigh Breast Care Centre, Pretoria, Gauteng, South Africa
Cape Town Oncology Trials, Kraaifontein, Western CAPE, South Africa
GVI Rondebosch Oncology Centre-Rondebosch Medical Centre, Rondebosch, Western CAPE, South Africa
National Cancer Institute, Ratchathewi, Bangkok, Thailand
Udonthani Cancer Hospital, Amphur Muang, Udonthani, Thailand
Faculty of Medicine, Chulongkorn University, Medical Oncology Unit, Bangkok, , Thailand
Baskent University School of Medicine Adana Hospital, Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi, Ankara, , Turkey
Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali, Bursa, , Turkey
Dicle University Medical Faculty, Diyarbakir, , Turkey
Gaziantep University Medical Faculty, Gaziantep, , Turkey
Istanbul Universitesi Onkoloji Enstitusu, Istanbul, , Turkey
Municipal Institution "Chernivtsi Regional Clinical Oncology Center", Outpatient Department, Chernivtsi, , Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital No.4of Dnipro Regional Council, Department of, Dnipro, , Ukraine
SI Institute of Medical Radiology n.a.S.P. Ilrygoriev of National Academy of Medical Science of, Kharkiv, , Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology", Kharkiv, , Ukraine
Khmelnytskyi Regional Oncologic Dispensary, Khmelnytskyi, , Ukraine
Municipal Enterprise 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council', Kryvyi Rih, , Ukraine
Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary", Kyiv, , Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Center, Lviv, , Ukraine
Municipal Institution Odesa Regional Clinical Hospital, Mammology Center, Odesa, , Ukraine
Zakarpattia Regional Clinical Oncological Center, Uzhgorod, , Ukraine
Municipal Non-profit Enterprise Podilsk Regional Oncology Centre of Vinnytsia Regional Council, Vinnytsia, , Ukraine
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
