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)

NCT ID: NCT01989676

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 707 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-24
• Study Completion Date: 2020-06-27

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PF-05280014

Group Type: EXPERIMENTAL

PF-05280014

Intervention Type: BIOLOGICAL

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

Intervention Type: DRUG

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®

Group Type: ACTIVE_COMPARATOR

Herceptin®

Intervention Type: BIOLOGICAL

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

Other Intervention Names

Trastuzumab-Pfizer; 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

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 Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

Sanatorio de la Providencia

C.a.b.a, , Argentina

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL

Londrina, Paraná, Brazil

Associacao Hospital de Caridade Ijui

Ijuí, Rio Grande do Sul, Brazil

Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

Lajeado, Rio Grande do Sul, Brazil

Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisas Oncologicas de Santa Catarina - CEPON

Florianópolis, Santa Catarina, Brazil

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Clinica Alemana de Temuco

Temuco, Región de la Araucanía, Chile

Centro de Investigacion Clinica SIM

Temuco, Región de la Araucanía, Chile

Administrative office

Temuco, Región de la Araucanía, Chile

Hospital Clinico Vina Del Mar

Viña del Mar, Región de Valparaíso, Chile

Instituto Oncologico, Clinica Renaca

Viña del Mar, Región de Valparaíso, Chile

Fresenius Kabi Chile Therapia iv

Santiago, RM, 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, , 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

Kecskemét, , 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-ken, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Japan Community Health care Organization Kurume General Hospital

Kurume, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kumamoto University Hospital

Kumamoto, 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

P.Stradins Clinical University Hospital

Riga, , Latvia

Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)

Mexico City, Mexico City, Mexico

Inter Hosp S.A. de C.V. "Centro Medico Dalinde"

Mexico City, Mexico City, Mexico

Instituto Nacional de Cancerologia

Mexico City, Mexico City, Mexico

Oaxaca Site Management Organization S.C.

Oaxaca City, , Mexico

Cancerologia de Queretaro S.C.

Querétaro, , 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

The Research Institute at Perpetual Succor Hospital

Cebu City, Central Visayas, Philippines

Cardinal Santos Medical Center

San Juan City, Mentro Manila, Philippines

Manila Doctors Hospital

Manila, National Capital Region, Philippines

Veterans Memorial Medical Center

Quezon City, National Capital Region, Philippines

University of Philippines Manila-Philippine General Hospital

Manila, NCR, Philippines

The Medical City

Pasig, NCR, Philippines

St. Luke's Medical Center

Quezon City, NCR, 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

Rzeszów, , Poland

Magodent Sp. z o.o. Oddzial Onkologii Klinicznej/Chemioterapii

Warsaw, , Poland

Hospital de Braga

Braga, , Portugal

Hospital CUF Descobertas

Lisbon, , 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

Bucharest, , 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

Timișoara, , Romania

GBUZ Republican Clinical Hospital n.a. G.F. Kuvatova

Ufa, Bashkortostan Republic, Russia

Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Baskortostan Republic

Ufa, Bashkortostan Republic, Russia

State Healthcare Institution, Republican Clinical Oncology Dispensary of the Ministry of

Ufa, Bashkortostan Republic, Russia

Republic Clinical Hospital of Emergency Care

Grozny, Chechenkaya Republic, Russia

State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee

Kislino Settlement, Kursk Oblast, Russia

State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"

Kuzmolovo, Vsevolozhskiy, Leningradskaya Oblast', Russia

FSBSI Russian Cancer Research Center n.a. N.N.Blokhin

Moscow, NAP, Russia

GBUZ of Perm region "Perm regional oncology dispensary"

Perm, NAP, Russia

Federal State Budgetary Institution ¿National Medical Research Oncology Centre named after N.N.

Saint Petersburg, Pos.pesochny, Russia

State Budgetary Healthcare Institution ''Republic Oncological Dispensary''

Petrozavodsk, Republic of Karelia, Russia

State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary"

Saransk, Respublika Mordoviya, Russia

Rostov Research Institute of Oncology

Rostov-on-Don, Rostov Oblast, Russia

Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

Poselok Pesochny, Sankt-Peterburg, Russia

Private medical institution Euromedservice

Pushkin, Sankt-Peterburg, Russia

LLC Medekspert

Kislovodsk, Stavropol Kray, Russia

Federal State Budgetary Healthcare Institution of "Clinical Hospital #101 of Federal Medical and

Lermontov, Stavropol Kray, Russia

Centre of Specialized kinds of Medical Care of Pyatigorsk city

Pyatigorsk, Stavropol Kray, Russia

State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncology Dispensary

Pyatigorsk, Stavropol Kray, Russia

LLC Novaya Clinica

Pyatigorsk, Stavropol Kray, Russia

Pyatigorsk City Hospital #2

Pyatigorsk, Stavropol Kray, Russia

Stavropol Regional Hospital for War Veterans

Pyatigorsk, Stavropol Kray, Russia

State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary

Volzhsky, Volgograd Oblast, Russia

GBUZ Arkhangelsk Regional Clinical Oncological dispensary

Arkhangelsk, , Russia

State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary"

Chelyabinsk, , Russia

"Regional Budgetary Healthcare Institution ""Ivanovo Regional Oncology Dispensary"""

Ivanovo, , Russia

SBIH of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"

Kaluga, , Russia

GBUZ "Regional Oncology Dispensary #2"

Magnitogorsk, , Russia

Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N. Blokhin" of

Moscow, , Russia

LLC VitaMed

Moscow, , Russia

LLC VitaMed

Moscow, , Russia

State Budgetary Healthcare Institution "Nizhniy Novgorod Regional Oncological Dispensary"

Nizhny Novgorod, , Russia

"BIH of Omsk Region ""Clinical oncological dispensary"""

Omsk, , Russia

Budgetary Institution of Healthcare of Orel region "Orel oncological dispensary"

Oryol, , Russia

SBEI HPE RyazSMU of MoH of the Russian Federation based on SBI of Ryazan Region "Regional CLinical

Ryazan, , Russia

SBI "North-Western State Medical University n.a. I. I. Mechnikov" of the MoH of the Russian

Saint Petersburg, , Russia

Non-state healthcare agency Road Clinical Hospital PLC Russian Railways

Saint Petersburg, , Russia

Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"

Saint Petersburg, , Russia

SBEI of HPE "First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Non-State Healthcare Institution "Road Clinical Hospital at Saratov II Station"

Saratov, , Russia

State Budgetary Healthcare Institution of Stavropol region "Stavropol regional clinical oncology

Stavropol, , Russia

Institute for Oncology and Radiology of Serbia

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Oncology Institute of Vojvodina

Kamenitz, , Serbia

Clinic of Oncology-Clinical Center Nis

Niš, , 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

Ulsan University Hospital

Ulsan, Korea, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Pusan National University Hospital

Busan, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

National Cancer Centre

Goyang-si, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

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 (Türkiye)

Hacettepe Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali

Bursa, , Turkey (Türkiye)

Dicle University Medical Faculty

Diyarbakır, , Turkey (Türkiye)

Gaziantep University Medical Faculty

Gaziantep, , Turkey (Türkiye)

Istanbul Universitesi Onkoloji Enstitusu

Istanbul, , Turkey (Türkiye)

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

Uzhhorod, , Ukraine

Municipal Non-profit Enterprise Podilsk Regional Oncology Centre of Vinnytsia Regional Council

Vinnytsia, , Ukraine

Countries

United States; Argentina; Brazil; Chile; Czechia; Greece; Hungary; India; Japan; Latvia; Mexico; Peru; Philippines; Poland; Portugal; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Thailand; Turkey (Türkiye); Ukraine

References

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.

Reference Type: DERIVED

PMID: 35133617 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31053945 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30568294 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3271002&StudyName=A%20Phase%203%20Randomized%2C%20Double-blind%20Study%20Of%20Pf-05280014%20Plus%20Paclitaxel%20Versus%20Trastuzumab%20Plus%20Paclitaxel%20For%20The%20First-line%20Treatment%20Of%20Patients%20With%20Her2-positive%20Metastatic%20Breast%20Cancer

Related Info

Other Identifiers

REFLECTIONS B327-02

Identifier Type: -

Identifier Source: secondary_id

2013-001352-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B3271002

Identifier Type: OTHER

Identifier Source: secondary_id

B3271002

Identifier Type: -

Identifier Source: org_study_id