Clinical trial NCT01989676: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Keywords: Phase 3
trastuzumab
Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 707
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of breast cancer.
* Presence of metastatic disease.
* Documentation of HER2 gene amplification or overexpression.
* Available tumor tissue for central review of HER2 status.
* At least 1 measurable lesion as defined by RECIST 1.1.
* Eastern Cooperative Oncology Group status of 0 to 2.
* Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan.

Exclusion Criteria:

* Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization.
* Prior systemic therapy for metastatic disease (except endocrine therapy).
* Prior cumulative dose of doxorubicin of \>400 mg/m2, epirubicin dose \>800 mg/m\^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m\^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m\^2 of doxorubicin.
* Inflammatory breast cancer.
* Active uncontrolled or symptomatic central nervous system metastases.

Primary outcomes:
measure: Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population
timeFrame: From the date of randomization until all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit
Secondary outcomes:
measure: One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population
timeFrame: From the date of randomization until 378 days post-randomization
measure: Duration of Response (DOR) Per Central Radiology Assessments: ITT Population
timeFrame: From the date of randomization until 378 days post-randomization
measure: Overall Survival: ITT Population
timeFrame: From the date of randomization until end of study (approximately 6 years)
measure: Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population
timeFrame: 1 hour post end of infusion on Day 1 of Cycles 1 and 5
measure: Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population
timeFrame: 1 hour post end of infusion on Day 1 of Cycles 1 and 5
measure: Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
timeFrame: Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5
measure: Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
timeFrame: Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
timeFrame: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 11, 14, 17
measure: Number of Participants With Positive Neutralizing Antibodies (Nab) Prior to Treatment: Safety Population
timeFrame: Cycle 1 Day 1 (prior to treatment)
Other outcomes:
Locations:
city: Plainville
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Boca Raton
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Plantation
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Berazategui
country: Argentina
facility: COIBA - Centro de Oncologia e Investigacion Buenos Aires
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto De Oncologia De Rosario
state: Santa FE
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
state: Tucuman
city: C.a.b.a
country: Argentina
facility: Sanatorio de la Providencia
city: Fortaleza
country: Brazil
facility: CRIO - Centro Regional Integrado de Oncologia
state: CE
city: Goiania
country: Brazil
facility: Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge
state: GO
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
state: Parana
city: Londrina
country: Brazil
facility: Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL
state: Parana
city: Lajeado
country: Brazil
facility: Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)
state: RIO Grande DO SUL
city: Ijui
country: Brazil
facility: Associacao Hospital de Caridade Ijui
state: RS
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia
state: RS
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: SAO Paulo
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas de Santa Catarina - CEPON
state: SC
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
state: SC
city: Santo Andre
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
state: SP
city: Santo Andre
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
state: SP
city: Temuco
country: Chile
facility: Clinica Alemana de Temuco
state: Region DE LA Araucania
city: Temuco
country: Chile
facility: Centro de Investigacion Clinica SIM
state: Region DE LA Araucania
city: Temuco
country: Chile
facility: Administrative office
state: Region DE LA Araucania
city: Santiago
country: Chile
facility: Fresenius Kabi Chile Therapia iv
state: RM
city: Vina del Mar
country: Chile
facility: Hospital Clinico Vina Del Mar
state: V Region
city: Vina del Mar
country: Chile
facility: Instituto Oncologico, Clinica Renaca
state: V Region
city: V Region
country: Chile
facility: Hospital Naval Almirante Nef
city: V Region
country: Chile
facility: Instituto Oncologico Clinica Renaca
city: Praha 2
country: Czechia
facility: Onkologicka klinika VFN a 1. LF UK, Fakultni poliklinika
city: Chania
country: Greece
facility: General Hospital of Chania "O Agios Georgios"
state: Crete
city: Pylaia
country: Greece
facility: Interbalkan European Medical Center
state: Thessaloniki
city: Athens
country: Greece
facility: General Hospital of Athens "Hippokration"
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz, Onkoradiologiai Kozpont
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Visakhapatnam
country: India
facility: Department of Medicine New Block
state: Andhra Pradesh
city: Bengaluru
country: India
facility: Manipal Hospital
state: Karnataka
city: Manipal
country: India
facility: Manipal Centre for Clinical Research
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Centre, Tata Memorial Hospital
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Super Speciality Hospital
state: Maharashtra
city: Navi Mumbai
country: India
facility: Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research & Development Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Cuttack
country: India
facility: Acharya Harihar Regional Cancer Center
state: Odisha
city: Bikaner
country: India
facility: Acharya Tulsi Regional Cancer Treatment and Research Institute
state: Rajasthan
city: Madurai
country: India
facility: Meenakshi Mission Hospital and Research Centre
state: Tamil NADU
city: Hyderabad
country: India
facility: MNJ Institute of Oncology & Regional Cancer Center
state: Telangana
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Fukuoka-Shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Kurume-city
country: Japan
facility: Japan Community Health care Organization Kurume General Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kumamoto-city
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center Hospital
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
state: Tokyo
city: Meguro-Ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Kagoshima
country: Japan
facility: Hakuaikai Medical Corporation Sagara Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Nakanoshima Osaka Breast Clinic
city: Osaka
country: Japan
facility: Osaka Breast Clinic
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Korea
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Centre
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Riga
country: Latvia
facility: P.Stradins Clinical University Hospital
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
state: Distrito Federal
city: Mexico
country: Mexico
facility: Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)
state: Distrito Federal
city: Mexico
country: Mexico
facility: Inter Hosp S.A. de C.V. "Centro Medico Dalinde"
state: Distrito Federal
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Queretaro
country: Mexico
facility: Cancerologia de Queretaro S.C.
city: Lima
country: Peru
facility: Hospital Militar Central
city: Lima
country: Peru
facility: INNPARES
city: Lima
country: Peru
facility: Resocentro
city: Lima
country: Peru
facility: Clinica Anglo Americana
city: Lima
country: Peru
facility: Instituto de Oncologia y Radioterapia de la Clinica Ricardo Palma
city: Lima
country: Peru
facility: Radiologos S.R.L.
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Siglo XXI
city: Lima
country: Peru
facility: Resocentro
city: Lima
country: Peru
facility: Siglo XXI
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital
state: Cebu
city: San Juan City
country: Philippines
facility: Cardinal Santos Medical Center
state: Mentro Manila
city: Manila
country: Philippines
facility: Manila Doctors Hospital
state: Metro Manila
city: Quezon City
country: Philippines
facility: Veterans Memorial Medical Center
state: Metro Manila
city: Manila
country: Philippines
facility: University of Philippines Manila-Philippine General Hospital
state: NCR
city: Pasig City
country: Philippines
facility: The Medical City
state: NCR
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: NCR
city: Cebu City
country: Philippines
facility: The Research Institute at Perpetual Succor Hospital
state: Region VII
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej
city: Olsztyn
country: Poland
facility: SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii
city: Rzeszow
country: Poland
facility: MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie
city: Warszawa
country: Poland
facility: Magodent Sp. z o.o. Oddzial Onkologii Klinicznej/Chemioterapii
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta
state: Cluj
city: Cluj-Napoca
country: Romania
facility: S.C. Medisprof S.R.L
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie
state: Dolj
city: Craiova
country: Romania
facility: SC Oncolab SRL, Oncologie
state: Jud Dolj
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta, Departamentul Oncologie Medicala
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta "Sf.Ioan cel Nou", Sectia Oncologie
city: Timisoara
country: Romania
facility: Spitalul Clinic Municipal de Urgenta Timisoara, Sectia Clinica Oncologie Medicala
city: Grozny
country: Russian Federation
facility: Republic Clinical Hospital of Emergency Care
state: Chechenkaya Republic
city: Kislino Settlement
country: Russian Federation
facility: State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee
state: Kursk
city: Kuzmolovo, Vsevolozhskiy
country: Russian Federation
facility: State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"
state: Leningrad Region
city: Moscow
country: Russian Federation
facility: FSBSI Russian Cancer Research Center n.a. N.N.Blokhin
state: NAP
city: Perm
country: Russian Federation
facility: GBUZ of Perm region "Perm regional oncology dispensary"
state: NAP
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution ¿National Medical Research Oncology Centre named after N.N.
state: Pos.pesochny
city: Ufa
country: Russian Federation
facility: State Healthcare Institution, Republican Clinical Oncology Dispensary of the Ministry of
state: Republic OF Bashkortostan
city: Ufa
country: Russian Federation
facility: GBUZ Republican Clinical Hospital n.a. G.F. Kuvatova
state: Republic OF Baskortostan
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Baskortostan Republic
state: Republic OF Baskortostan
city: Petrozavodsk
country: Russian Federation
facility: State Budgetary Healthcare Institution ''Republic Oncological Dispensary''
state: Republic OF Karelia
city: Saransk
country: Russian Federation
facility: State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary"
state: Republic OF Mordovia
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Research Institute of Oncology
state: Rostov Region
city: Pushkin
country: Russian Federation
facility: Private medical institution Euromedservice
state: Saint Petersburg
city: Poselok Pesochny
country: Russian Federation
facility: Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
state: Saint-petersburg
city: Kislovodsk
country: Russian Federation
facility: LLC Medekspert
state: Stavropol Region
city: Lermontov
country: Russian Federation
facility: Federal State Budgetary Healthcare Institution of "Clinical Hospital #101 of Federal Medical and
state: Stavropol Region
city: Pyatigorsk
country: Russian Federation
facility: Centre of Specialized kinds of Medical Care of Pyatigorsk city
state: Stavropol Region
city: Pyatigorsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncology Dispensary
state: Stavropol Region
city: Pyatigorsk
country: Russian Federation
facility: LLC Novaya Clinica
state: Stavropol Region
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk City Hospital #2
state: Stavropol Region
city: Pyatigorsk
country: Russian Federation
facility: Stavropol Regional Hospital for War Veterans
state: Stavropol Region
city: Volzhskiy
country: Russian Federation
facility: State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
state: Volgograd Region
city: Arkhangelsk
country: Russian Federation
facility: GBUZ Arkhangelsk Regional Clinical Oncological dispensary
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary"
city: Ivanovo
country: Russian Federation
facility: Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
city: Kaluga
country: Russian Federation
facility: SBIH of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"
city: Magnitogorsk
country: Russian Federation
facility: GBUZ "Regional Oncology Dispensary #2"
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N. Blokhin" of
city: Moscow
country: Russian Federation
facility: LLC VitaMed
city: Moscow
country: Russian Federation
facility: LLC VitaMed
city: Nizhniy Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution "Nizhniy Novgorod Regional Oncological Dispensary"
city: Omsk
country: Russian Federation
facility: BIH of Omsk Region "Clinical oncological dispensary"
city: Orel
country: Russian Federation
facility: Budgetary Institution of Healthcare of Orel region "Orel oncological dispensary"
city: Ryazan
country: Russian Federation
facility: SBEI HPE RyazSMU of MoH of the Russian Federation based on SBI of Ryazan Region "Regional CLinical
city: Saint Petersburg
country: Russian Federation
facility: SBEI of HPE "First Saint Petersburg State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: SBI "North-Western State Medical University n.a. I. I. Mechnikov" of the MoH of the Russian
city: Saint-Petersburg
country: Russian Federation
facility: Non-state healthcare agency Road Clinical Hospital PLC Russian Railways
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"
city: Saratov
country: Russian Federation
facility: Non-State Healthcare Institution "Road Clinical Hospital at Saratov II Station"
city: Stavropol
country: Russian Federation
facility: State Budgetary Healthcare Institution of Stavropol region "Stavropol regional clinical oncology
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Nis
country: Serbia
facility: Clinic of Oncology-Clinical Center Nis
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
city: Bratislava
country: Slovakia
facility: Onkologicky ustav sv. Alzbety, s.r.o.
city: Bratislava
country: Slovakia
facility: Narodny Onkologicky Ustav
city: Port Elizabeth
country: South Africa
facility: GVI Oncology, Langenhoven Drive Oncology Centre
state: Eastern CAPE
city: Joannesburg
country: South Africa
facility: wits Clinical Research
state: Gauteng
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: *Department of Medical Oncology, University of Pretoria & Steve Biko Academic Hospitals Complex
state: Gauteng
city: Pretoria
country: South Africa
facility: Eastleigh Breast Care Centre
state: Gauteng
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials
state: Western CAPE
city: Rondebosch
country: South Africa
facility: GVI Rondebosch Oncology Centre-Rondebosch Medical Centre
state: Western CAPE
city: Ratchathewi
country: Thailand
facility: National Cancer Institute
state: Bangkok
city: Amphur Muang
country: Thailand
facility: Udonthani Cancer Hospital
state: Udonthani
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulongkorn University, Medical Oncology Unit
city: Adana
country: Turkey
facility: Baskent University School of Medicine Adana Hospital
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
city: Diyarbakir
country: Turkey
facility: Dicle University Medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Onkoloji Enstitusu
city: Chernivtsi
country: Ukraine
facility: Municipal Institution "Chernivtsi Regional Clinical Oncology Center", Outpatient Department
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4of Dnipro Regional Council, Department of
city: Kharkiv
country: Ukraine
facility: SI Institute of Medical Radiology n.a.S.P. Ilrygoriev of National Academy of Medical Science of
city: Kharkiv
country: Ukraine
facility: Communal Non-Profit Enterprise "Regional Center of Oncology"
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi Regional Oncologic Dispensary
city: Kryvyi Rih
country: Ukraine
facility: Municipal Enterprise 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
city: Kyiv
country: Ukraine
facility: Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"
city: Lviv
country: Ukraine
facility: Lviv State Oncologic Regional Treatment and Diagnostic Center
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital, Mammology Center
city: Uzhgorod
country: Ukraine
facility: Zakarpattia Regional Clinical Oncological Center
city: Vinnytsia
country: Ukraine
facility: Municipal Non-profit Enterprise Podilsk Regional Oncology Centre of Vinnytsia Regional Council
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Li RK, Tokunaga E, Adamchuk H, Vladimirov V, Yanez E, Lee KS, Bondarenko I, Vana A, Hilton F, Ishikawa T, Tajima K, Lipatov O. Long-Term Safety and Effectiveness of PF-05280014 (a Trastuzumab Biosimilar) Treatment in Patients with HER2-Positive Metastatic Breast Cancer: Updated Results of a Randomized, Double-Blind Study. BioDrugs. 2022 Jan;36(1):55-69. doi: 10.1007/s40259-021-00513-7. Epub 2022 Feb 8.
citation: Chen X, Li C, Ewesuedo R, Yin D. Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin(R)) in patients with HER2-positive metastatic breast cancer. Cancer Chemother Pharmacol. 2019 Jul;84(1):83-92. doi: 10.1007/s00280-019-03850-1. Epub 2019 May 3.
citation: Pegram MD, Bondarenko I, Zorzetto MMC, Hingmire S, Iwase H, Krivorotko PV, Lee KS, Li RK, Pikiel J, Aggarwal R, Ewesuedo R, Freyman A, Li R, Vana A, Yin D, Zacharchuk C, Tan-Chiu E. PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study. Br J Cancer. 2019 Jan;120(2):172-182. doi: 10.1038/s41416-018-0340-2. Epub 2018 Dec 20.