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)
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
3 other identifiers
interventional
707
24 countries
188
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2014
Longer than P75 for phase_3
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedStudy Start
First participant enrolled
February 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2016
CompletedResults Posted
Study results publicly available
January 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2020
CompletedJuly 6, 2021
June 1, 2021
2.5 years
October 28, 2013
September 13, 2017
June 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population
ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.
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 (9)
One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population
From the date of randomization until 378 days post-randomization
Duration of Response (DOR) Per Central Radiology Assessments: ITT Population
From the date of randomization until 378 days post-randomization
Overall Survival: ITT Population
From the date of randomization until end of study (approximately 6 years)
Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population
1 hour post end of infusion on Day 1 of Cycles 1 and 5
Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population
1 hour post end of infusion on Day 1 of Cycles 1 and 5
- +4 more secondary outcomes
Study Arms (2)
PF-05280014
EXPERIMENTALHerceptin®
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (188)
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062, United States
Cancer Center of Central Connecticut
Southington, Connecticut, 06489, United States
Florida Cancer Research Institute
Boca Raton, Florida, 33428, United States
Florida Cancer Research Institute
Plantation, Florida, 33324, United States
COIBA - Centro de Oncologia e Investigacion Buenos Aires
Berazategui, Buenos Aires, B1884BBF, Argentina
Instituto De Oncologia De Rosario
Rosario, Santa Fe Province, S2000KZE, Argentina
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina
Sanatorio de la Providencia
C.a.b.a, C1050AAK, Argentina
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-045, Brazil
Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge
Goiânia, Goiás, 74605070, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL
Londrina, Paraná, 86015-520, Brazil
Associacao Hospital de Caridade Ijui
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)
Lajeado, Rio Grande do Sul, 95900-000, Brazil
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Centro de Pesquisas Oncologicas de Santa Catarina - CEPON
Florianópolis, Santa Catarina, 88034-000, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-215, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870, Brazil
Clinica Alemana de Temuco
Temuco, Región de la Araucanía, 4810297, Chile
Centro de Investigacion Clinica SIM
Temuco, Región de la Araucanía, 4810469, Chile
Administrative office
Temuco, Región de la Araucanía, 4810561, Chile
Hospital Clinico Vina Del Mar
Viña del Mar, Región de Valparaíso, 2520612, Chile
Instituto Oncologico, Clinica Renaca
Viña del Mar, Región de Valparaíso, 2540364, Chile
Fresenius Kabi Chile Therapia iv
Santiago, RM, 7780050, Chile
Hospital Naval Almirante Nef
V Region, Chile
Instituto Oncologico Clinica Renaca
V Region, Chile
Onkologicka klinika VFN a 1. LF UK, Fakultni poliklinika
Prague, 128 08, Czechia
General Hospital of Chania "O Agios Georgios"
Chania, Crete, 73300, Greece
Interbalkan European Medical Center
Pylaia, Thessaloniki, 57001, Greece
General Hospital of Athens "Hippokration"
Athens, 11527, Greece
Bacs-Kiskun Megyei Korhaz, Onkoradiologiai Kozpont
Kecskemét, 6000, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias
Miskolc, 3526, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont
Szolnok, 5000, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700, Hungary
Department of Medicine New Block
Visakhapatnam, Andhra Pradesh, 530002, India
Manipal Hospital
Bengaluru, Karnataka, 560017, India
Manipal Centre for Clinical Research
Manipal, Karnataka, 576104, India
Tata Memorial Centre, Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
Shatabdi Super Speciality Hospital
Nashik, Maharashtra, 422 005, India
Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharashtra, 401210, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411 004, India
Sahyadri Clinical Research & Development Centre
Pune, Maharashtra, 411004, India
Sahyadri Speciality Hospital
Pune, Maharashtra, 411004, India
Acharya Harihar Regional Cancer Center
Cuttack, Odisha, 753007, India
Acharya Tulsi Regional Cancer Treatment and Research Institute
Bikaner, Rajasthan, 334003, India
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, 625107, India
MNJ Institute of Oncology & Regional Cancer Center
Hyderabad, Telangana, 500004, India
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Japan Community Health care Organization Kurume General Hospital
Kurume, Fukuoka, 830-0013, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 8608556, Japan
Saitama Cancer Center Hospital
Kitaadachi-gun, Saitama, 362-0806, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, 892-0833, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Nakanoshima Osaka Breast Clinic
Osaka, 553-0003, Japan
Osaka Breast Clinic
Osaka, 553-0003, Japan
Shizuoka General Hospital
Shizuoka, 420-8527, Japan
P.Stradins Clinical University Hospital
Riga, LV 1002, Latvia
Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)
Mexico City, Mexico City, 06760, Mexico
Inter Hosp S.A. de C.V. "Centro Medico Dalinde"
Mexico City, Mexico City, 06760, Mexico
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14080, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000, Mexico
Cancerologia de Queretaro S.C.
Querétaro, 76090, Mexico
Hospital Militar Central
Lima, 11, Peru
INNPARES
Lima, 11, Peru
Resocentro
Lima, 18, Peru
Clinica Anglo Americana
Lima, 27, Peru
Instituto de Oncologia y Radioterapia de la Clinica Ricardo Palma
Lima, 27, Peru
Radiologos S.R.L.
Lima, 27, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, 34, Peru
Siglo XXI
Lima, 41, Peru
Resocentro
Lima, Lima 18, Peru
Siglo XXI
Lima, Lima 41, Peru
Cebu Doctors' University Hospital
Cebu City, CEBU, 6000, Philippines
The Research Institute at Perpetual Succor Hospital
Cebu City, Central Visayas, 6000, Philippines
Cardinal Santos Medical Center
San Juan City, Mentro Manila, 1502, Philippines
Manila Doctors Hospital
Manila, National Capital Region, 1000, Philippines
Veterans Memorial Medical Center
Quezon City, National Capital Region, 1110, Philippines
University of Philippines Manila-Philippine General Hospital
Manila, NCR, 1000, Philippines
The Medical City
Pasig, NCR, 1605, Philippines
St. Luke's Medical Center
Quezon City, NCR, 1102, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, 80-219, Poland
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
Gdynia, 81-519, Poland
Centrum Terapii Wspolczesnej
Lodz, 90-242, Poland
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii
Olsztyn, 10-228, Poland
MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie
Rzeszów, 35-085, Poland
Magodent Sp. z o.o. Oddzial Onkologii Klinicznej/Chemioterapii
Warsaw, 03-291, Poland
Hospital de Braga
Braga, 4710 243, Portugal
Hospital CUF Descobertas
Lisbon, 1998-018, Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, 400015, Romania
S.C. Medisprof S.R.L
Cluj-Napoca, Cluj, 400641, Romania
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, 200347, Romania
SC Oncolab SRL, Oncologie
Craiova, JUD DOLJ, 200385, Romania
Spitalul Universitar de Urgenta, Departamentul Oncologie Medicala
Bucharest, 050098, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245, Romania
Spitalul Judetean de Urgenta "Sf.Ioan cel Nou", Sectia Oncologie
Suceava, 720237, Romania
Spitalul Clinic Municipal de Urgenta Timisoara, Sectia Clinica Oncologie Medicala
Timișoara, 300595, Romania
GBUZ Republican Clinical Hospital n.a. G.F. Kuvatova
Ufa, Bashkortostan Republic, 450005, Russia
Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Baskortostan Republic
Ufa, Bashkortostan Republic, 450054, Russia
State Healthcare Institution, Republican Clinical Oncology Dispensary of the Ministry of
Ufa, Bashkortostan Republic, 450054, Russia
Republic Clinical Hospital of Emergency Care
Grozny, Chechenkaya Republic, 364020, Russia
State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee
Kislino Settlement, Kursk Oblast, 305524, Russia
State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"
Kuzmolovo, Vsevolozhskiy, Leningradskaya Oblast', 188663, Russia
FSBSI Russian Cancer Research Center n.a. N.N.Blokhin
Moscow, NAP, 115478, Russia
GBUZ of Perm region "Perm regional oncology dispensary"
Perm, NAP, 614066, Russia
Federal State Budgetary Institution ¿National Medical Research Oncology Centre named after N.N.
Saint Petersburg, Pos.pesochny, 197758, Russia
State Budgetary Healthcare Institution ''Republic Oncological Dispensary''
Petrozavodsk, Republic of Karelia, 185002, Russia
State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary"
Saransk, Respublika Mordoviya, 430032, Russia
Rostov Research Institute of Oncology
Rostov-on-Don, Rostov Oblast, 344037, Russia
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
Poselok Pesochny, Sankt-Peterburg, 197758, Russia
Private medical institution Euromedservice
Pushkin, Sankt-Peterburg, 196603, Russia
LLC Medekspert
Kislovodsk, Stavropol Kray, 357700, Russia
Federal State Budgetary Healthcare Institution of "Clinical Hospital #101 of Federal Medical and
Lermontov, Stavropol Kray, 357340, Russia
Centre of Specialized kinds of Medical Care of Pyatigorsk city
Pyatigorsk, Stavropol Kray, 357502, Russia
State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncology Dispensary
Pyatigorsk, Stavropol Kray, 357502, Russia
LLC Novaya Clinica
Pyatigorsk, Stavropol Kray, 357519, Russia
Pyatigorsk City Hospital #2
Pyatigorsk, Stavropol Kray, 357538, Russia
Stavropol Regional Hospital for War Veterans
Pyatigorsk, Stavropol Kray, 357563, Russia
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volzhsky, Volgograd Oblast, 404130, Russia
GBUZ Arkhangelsk Regional Clinical Oncological dispensary
Arkhangelsk, 163045, Russia
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary"
Chelyabinsk, 454087, Russia
"Regional Budgetary Healthcare Institution ""Ivanovo Regional Oncology Dispensary"""
Ivanovo, 153040, Russia
SBIH of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"
Kaluga, 248007, Russia
GBUZ "Regional Oncology Dispensary #2"
Magnitogorsk, 455001, Russia
Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N. Blokhin" of
Moscow, 115478, Russia
LLC VitaMed
Moscow, 121309, Russia
LLC VitaMed
Moscow, 129515, Russia
State Budgetary Healthcare Institution "Nizhniy Novgorod Regional Oncological Dispensary"
Nizhny Novgorod, 603081, Russia
"BIH of Omsk Region ""Clinical oncological dispensary"""
Omsk, 644046, Russia
Budgetary Institution of Healthcare of Orel region "Orel oncological dispensary"
Oryol, 302020, Russia
SBEI HPE RyazSMU of MoH of the Russian Federation based on SBI of Ryazan Region "Regional CLinical
Ryazan, 390011, Russia
SBI "North-Western State Medical University n.a. I. I. Mechnikov" of the MoH of the Russian
Saint Petersburg, 195067, Russia
Non-state healthcare agency Road Clinical Hospital PLC Russian Railways
Saint Petersburg, 195271, Russia
Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"
Saint Petersburg, 196247, Russia
SBEI of HPE "First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
Non-State Healthcare Institution "Road Clinical Hospital at Saratov II Station"
Saratov, 410004, Russia
State Budgetary Healthcare Institution of Stavropol region "Stavropol regional clinical oncology
Stavropol, 355047, Russia
Institute for Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Oncology Institute of Vojvodina
Kamenitz, 21204, Serbia
Clinic of Oncology-Clinical Center Nis
Niš, 18000, Serbia
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava, 812 50, Slovakia
Narodny Onkologicky Ustav
Bratislava, 833 10, Slovakia
GVI Oncology, Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, 6045, South Africa
wits Clinical Research
Joannesburg, Gauteng, 2193, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
Sandton Oncology Centre
Johannesburg, Gauteng, 2199, South Africa
*Department of Medical Oncology, University of Pretoria & Steve Biko Academic Hospitals Complex
Pretoria, Gauteng, 0002, South Africa
Eastleigh Breast Care Centre
Pretoria, Gauteng, 0081, South Africa
Cape Town Oncology Trials
Kraaifontein, Western Cape, 7570, South Africa
GVI Rondebosch Oncology Centre-Rondebosch Medical Centre
Rondebosch, Western Cape, 7700, South Africa
Ulsan University Hospital
Ulsan, Korea, 44033, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
National Cancer Centre
Goyang-si, 10408, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
National Cancer Institute
Ratchathewi, Bangkok, 10400, Thailand
Udonthani Cancer Hospital
Amphur Muang, Udonthani, 41330, Thailand
Faculty of Medicine, Chulongkorn University, Medical Oncology Unit
Bangkok, 10330, Thailand
Baskent University School of Medicine Adana Hospital
Adana, 01120, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
Bursa, 16059, Turkey (Türkiye)
Dicle University Medical Faculty
Diyarbakır, 21080, Turkey (Türkiye)
Gaziantep University Medical Faculty
Gaziantep, 27310, Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, 34093, Turkey (Türkiye)
Municipal Institution "Chernivtsi Regional Clinical Oncology Center", Outpatient Department
Chernivtsi, 58013, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital No.4of Dnipro Regional Council, Department of
Dnipro, 49102, Ukraine
SI Institute of Medical Radiology n.a.S.P. Ilrygoriev of National Academy of Medical Science of
Kharkiv, 61024, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology"
Kharkiv, 61070, Ukraine
Khmelnytskyi Regional Oncologic Dispensary
Khmelnytskyi, 29009, Ukraine
Municipal Enterprise 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
Kryvyi Rih, 50048, Ukraine
Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"
Kyiv, 04107, Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, 79031, Ukraine
Municipal Institution Odesa Regional Clinical Hospital, Mammology Center
Odesa, 65025, Ukraine
Zakarpattia Regional Clinical Oncological Center
Uzhhorod, 88014, Ukraine
Municipal Non-profit Enterprise Podilsk Regional Oncology Centre of Vinnytsia Regional Council
Vinnytsia, 21029, Ukraine
Related Publications (3)
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.
PMID: 35133617DERIVEDChen 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.
PMID: 31053945DERIVEDPegram 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.
PMID: 30568294DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 21, 2013
Study Start
February 24, 2014
Primary Completion
August 24, 2016
Study Completion
June 27, 2020
Last Updated
July 6, 2021
Results First Posted
January 23, 2018
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.