AzTrials
AzTrials

Metastatic Breast CancerPhase 3NCT01989676

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 study testing PF-05280014, Paclitaxel and Herceptin® in people with Metastatic Breast Cancer, run by Pfizer at 188 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
PF-05280014, Paclitaxel and Herceptin®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
707 participants
Where
188 sitesin 24 countries
Study dates
24 Feb 2014to 27 Jun 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

188 sites in 24 countries.

188 sites in 24 countries

Russia40 sites

  • GBUZ Arkhangelsk Regional Clinical Oncological dispensary

    Arkhangelsk, 163045

  • State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary"

    Chelyabinsk, 454087

  • Republic Clinical Hospital of Emergency Care

    Grozny, Chechenkaya Republic, 364020

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

    Ivanovo, 153040

  • SBIH of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"

    Kaluga, 248007

  • State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee

    Kislino Settlement, Kursk Oblast, 305524

  • LLC Medekspert

    Kislovodsk, Stavropol Kray, 357700

  • State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"

    Kuzmolovo, Vsevolozhskiy, Leningradskaya Oblast', 188663

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

    Lermontov, Stavropol Kray, 357340

  • GBUZ "Regional Oncology Dispensary #2"

    Magnitogorsk, 455001

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

    Moscow, NAP, 115478

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

    Moscow, 115478

  • LLC VitaMed

    Moscow, 121309

  • LLC VitaMed

    Moscow, 129515

  • State Budgetary Healthcare Institution "Nizhniy Novgorod Regional Oncological Dispensary"

    Nizhny Novgorod, 603081

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

    Omsk, 644046

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

    Oryol, 302020

  • GBUZ of Perm region "Perm regional oncology dispensary"

    Perm, NAP, 614066

  • State Budgetary Healthcare Institution ''Republic Oncological Dispensary''

    Petrozavodsk, Republic of Karelia, 185002

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

    Poselok Pesochny, Sankt-Peterburg, 197758

  • Private medical institution Euromedservice

    Pushkin, Sankt-Peterburg, 196603

  • Centre of Specialized kinds of Medical Care of Pyatigorsk city

    Pyatigorsk, Stavropol Kray, 357502

  • State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncology Dispensary

    Pyatigorsk, Stavropol Kray, 357502

  • LLC Novaya Clinica

    Pyatigorsk, Stavropol Kray, 357519

  • Pyatigorsk City Hospital #2

    Pyatigorsk, Stavropol Kray, 357538

  • Stavropol Regional Hospital for War Veterans

    Pyatigorsk, Stavropol Kray, 357563

  • Rostov Research Institute of Oncology

    Rostov-on-Don, Rostov Oblast, 344037

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

    Ryazan, 390011

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

    Saint Petersburg, Pos.pesochny, 197758

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

    Saint Petersburg, 195067

  • Non-state healthcare agency Road Clinical Hospital PLC Russian Railways

    Saint Petersburg, 195271

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

    Saint Petersburg, 196247

  • SBEI of HPE "First Saint Petersburg State Medical University

    Saint Petersburg, 197022

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

    Saransk, Respublika Mordoviya, 430032

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

    Saratov, 410004

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

    Stavropol, 355047

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

    Ufa, Bashkortostan Republic, 450005

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

    Ufa, Bashkortostan Republic, 450054

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

    Ufa, Bashkortostan Republic, 450054

  • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary

    Volzhsky, Volgograd Oblast, 404130

Other trials in Russia

Japan15 sites

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima, 892-0833

  • Saitama Cancer Center Hospital

    Kitaadachi-gun, Saitama, 362-0806

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 8608556

  • Japan Community Health care Organization Kurume General Hospital

    Kurume, Fukuoka, 830-0013

  • National Hospital Organization Tokyo Medical Center

    Meguro-Ku, Tokyo, 152-8902

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Nakanoshima Osaka Breast Clinic

    Osaka, 553-0003

  • Osaka Breast Clinic

    Osaka, 553-0003

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 142-8666

  • Shizuoka General Hospital

    Shizuoka, 420-8527

Other trials in Japan

Brazil13 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Centro de Pesquisas Oncologicas de Santa Catarina - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • CRIO - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-045

  • Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge

    Goiânia, Goiás, 74605070

  • Associacao Hospital de Caridade Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-215

  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

    Lajeado, Rio Grande do Sul, 95900-000

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

    Londrina, Paraná, 86015-520

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Santo André, São Paulo, 09060-650

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

    Santo André, São Paulo, 09060-870

Other trials in Brazil

India13 sites

  • Manipal Hospital

    Bengaluru, Karnataka, 560017

  • Acharya Tulsi Regional Cancer Treatment and Research Institute

    Bikaner, Rajasthan, 334003

  • Acharya Harihar Regional Cancer Center

    Cuttack, Odisha, 753007

  • MNJ Institute of Oncology & Regional Cancer Center

    Hyderabad, Telangana, 500004

  • Meenakshi Mission Hospital and Research Centre

    Madurai, Tamil Nadu, 625107

  • Manipal Centre for Clinical Research

    Manipal, Karnataka, 576104

  • Tata Memorial Centre, Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • Shatabdi Super Speciality Hospital

    Nashik, Maharashtra, 422 005

  • Advanced Centre for Treatment Research and Education in Cancer (ACTREC)

    Navi Mumbai, Maharashtra, 401210

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411 004

  • Sahyadri Clinical Research & Development Centre

    Pune, Maharashtra, 411004

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411004

  • Department of Medicine New Block

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Ukraine11 sites

  • Municipal Institution "Chernivtsi Regional Clinical Oncology Center", Outpatient Department

    Chernivtsi, 58013

  • Municipal Non-Profit Enterprise City Clinical Hospital No.4of Dnipro Regional Council, Department of

    Dnipro, 49102

  • SI Institute of Medical Radiology n.a.S.P. Ilrygoriev of National Academy of Medical Science of

    Kharkiv, 61024

  • Communal Non-Profit Enterprise "Regional Center of Oncology"

    Kharkiv, 61070

  • Khmelnytskyi Regional Oncologic Dispensary

    Khmelnytskyi, 29009

  • Municipal Enterprise 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

    Kryvyi Rih, 50048

  • Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary"

    Kyiv, 04107

  • Lviv State Oncologic Regional Treatment and Diagnostic Center

    Lviv, 79031

  • Municipal Institution Odesa Regional Clinical Hospital, Mammology Center

    Odesa, 65025

  • Zakarpattia Regional Clinical Oncological Center

    Uzhhorod, 88014

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

    Vinnytsia, 21029

Other trials in Ukraine

Peru10 sites

  • Hospital Militar Central

    Lima, 11

  • INNPARES

    Lima, 11

  • Resocentro

    Lima, 18

  • Clinica Anglo Americana

    Lima, 27

  • Instituto de Oncologia y Radioterapia de la Clinica Ricardo Palma

    Lima, 27

  • Radiologos S.R.L.

    Lima, 27

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 34

  • Siglo XXI

    Lima, 41

  • Resocentro

    Lima, Lima 18

  • Siglo XXI

    Lima, Lima 41

Other trials in Peru

Philippines9 sites

  • Cebu Doctors' University Hospital

    Cebu City, CEBU, 6000

  • The Research Institute at Perpetual Succor Hospital

    Cebu City, Central Visayas, 6000

  • Manila Doctors Hospital

    Manila, National Capital Region, 1000

  • University of Philippines Manila-Philippine General Hospital

    Manila, NCR, 1000

  • Manila Doctors Hospital

    Manila, 1000

  • The Medical City

    Pasig, NCR, 1605

  • Veterans Memorial Medical Center

    Quezon City, National Capital Region, 1110

  • St. Luke's Medical Center

    Quezon City, NCR, 1102

  • Cardinal Santos Medical Center

    San Juan City, Mentro Manila, 1502

Other trials in Philippines

Chile8 sites

  • Fresenius Kabi Chile Therapia iv

    Santiago, RM, 7780050

  • Clinica Alemana de Temuco

    Temuco, Araucania, 4810297

  • Centro de Investigacion Clinica SIM

    Temuco, Araucania, 4810469

  • Administrative office

    Temuco, Araucania, 4810561

  • Hospital Naval Almirante Nef

    V Region

  • Instituto Oncologico Clinica Renaca

    V Region

  • Hospital Clinico Vina Del Mar

    Viña del Mar, Valparaiso, 2520612

  • Instituto Oncologico, Clinica Renaca

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Romania8 sites

  • Spitalul Universitar de Urgenta, Departamentul Oncologie Medicala

    Bucharest, 050098

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj, 400015

  • S.C. Medisprof S.R.L

    Cluj-Napoca, Cluj, 400641

  • Centrul de Oncologie Sf. Nectarie

    Craiova, Dolj, 200347

  • SC Oncolab SRL, Oncologie

    Craiova, JUD DOLJ, 200385

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Spitalul Judetean de Urgenta "Sf.Ioan cel Nou", Sectia Oncologie

    Suceava, 720237

  • Spitalul Clinic Municipal de Urgenta Timisoara, Sectia Clinica Oncologie Medicala

    Timișoara, 300595

Other trials in Romania

South Africa8 sites

  • wits Clinical Research

    Joannesburg, Gauteng, 2193

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Sandton Oncology Centre

    Johannesburg, Gauteng, 2199

  • Cape Town Oncology Trials

    Kraaifontein, Western Cape, 7570

  • GVI Oncology, Langenhoven Drive Oncology Centre

    Port Elizabeth, Eastern Cape, 6045

  • *Department of Medical Oncology, University of Pretoria & Steve Biko Academic Hospitals Complex

    Pretoria, Gauteng, 0002

  • Eastleigh Breast Care Centre

    Pretoria, Gauteng, 0081

  • GVI Rondebosch Oncology Centre-Rondebosch Medical Centre

    Rondebosch, Western Cape, 7700

Other trials in South Africa

South Korea8 sites

  • Pusan National University Hospital

    Busan, 49241

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Centre

    Goyang-si, 10408

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Korea University Guro Hospital

    Seoul, 08308

  • Ulsan University Hospital

    Ulsan, Korea, 44033

Other trials in South Korea

Poland6 sites

  • COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii

    Gdansk, 80-219

  • Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii

    Gdynia, 81-519

  • Centrum Terapii Wspolczesnej

    Lodz, 90-242

  • SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii

    Olsztyn, 10-228

  • MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie

    Rzeszów, 35-085

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

    Warsaw, 03-291

Other trials in Poland

Turkey (Türkiye)6 sites

  • Baskent University School of Medicine Adana Hospital

    Adana, 01120

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06100

  • Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali

    Bursa, 16059

  • Dicle University Medical Faculty

    Diyarbakır, 21080

  • Gaziantep University Medical Faculty

    Gaziantep, 27310

  • Istanbul Universitesi Onkoloji Enstitusu

    Istanbul, 34093

Other trials in Turkey (Türkiye)

Mexico5 sites

  • Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)

    Mexico City, Mexico City, 06760

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

    Mexico City, Mexico City, 06760

  • Instituto Nacional de Cancerologia

    Mexico City, Mexico City, 14080

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000

  • Cancerologia de Queretaro S.C.

    Querétaro, 76090

Other trials in Mexico

United States4 sites

  • Florida Cancer Research Institute

    Boca Raton, Florida, 33428

  • Cancer Center of Central Connecticut

    Plainville, Connecticut, 06062

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

Other trials in United States

Argentina4 sites

  • COIBA - Centro de Oncologia e Investigacion Buenos Aires

    Berazategui, Buenos Aires, B1884BBF

  • Sanatorio de la Providencia

    C.a.b.a, C1050AAK

  • Instituto De Oncologia De Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Hungary4 sites

  • Bacs-Kiskun Megyei Korhaz, Onkoradiologiai Kozpont

    Kecskemét, 6000

  • Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias

    Miskolc, 3526

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont

    Szolnok, 5000

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

Other trials in Hungary

Serbia4 sites

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

  • Clinic of Oncology-Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Greece3 sites

  • General Hospital of Athens "Hippokration"

    Athens, 11527

  • General Hospital of Chania "O Agios Georgios"

    Chania, Crete, 73300

  • Interbalkan European Medical Center

    Pylaia, Thessaloniki, 57001

Other trials in Greece

Thailand3 sites

  • Udonthani Cancer Hospital

    Amphur Muang, Udonthani, 41330

  • Faculty of Medicine, Chulongkorn University, Medical Oncology Unit

    Bangkok, 10330

  • National Cancer Institute

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

Portugal2 sites

  • Hospital de Braga

    Braga, 4710 243

  • Hospital CUF Descobertas

    Lisbon, 1998-018

Other trials in Portugal

Slovakia2 sites

  • Onkologicky ustav sv. Alzbety, s.r.o.

    Bratislava, 812 50

  • Narodny Onkologicky Ustav

    Bratislava, 833 10

Other trials in Slovakia

Czechia1 site

  • Onkologicka klinika VFN a 1. LF UK, Fakultni poliklinika

    Prague, 128 08

Other trials in Czechia

Latvia1 site

  • P.Stradins Clinical University Hospital

    Riga, LV 1002

Other trials in Latvia

About this study

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

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.

Being tested
PF-05280014, Paclitaxel, Herceptin®
Keywords
Phase 3, trastuzumab, Breast Neoplasms
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-05280014Biological

    Also called Trastuzumab-Pfizer

    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.

  • PaclitaxelDrug

    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®Biological

    Also called Trastuzumab (EU)

    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.

  • PaclitaxelDrug

    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.

Study groups in NCT01989676
Study groupRoleWhat they receive
PF-05280014ExperimentalNot described
Receives: Biological: PF-05280014; Drug: Paclitaxel
Herceptin®Active comparatorNot described
Receives: Biological: Herceptin®; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population

    One-year PFS rate was analyzed based on the time from date of randomization to first documentation of progressive disease (PD), or death due to any cause in the absence of documented PD, based on the assessments of the central radiology review in accordance with RECIST 1.1. PD was defined for target disease as at least a 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy) with a minimum absolute increase of 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method.

    Measured: From the date of randomization until 378 days post-randomization

  2. Duration of Response (DOR) Per Central Radiology Assessments: ITT Population

    DOR:time from first documentation of objective response (CR or PR) to first documentation of PD/death due to any cause in absence of documented PD, based on central radiology review. As per RECIST v1.1, CR:complete disappearance of all target lesions with exception of nodal disease; all target nodes reduced in short axis <10 mm. PR: >=30% decrease from baseline of SOD of target lesions; short diameter used in sum for target nodes,longest diameter used in sum for other target lesions. PD for target disease:at least 20% increase in SOD of target lesions above smallest sum observed (over baseline if no decrease in sum observed) with minimum absolute increase of 5 mm. For non-target disease:unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. The 95% CI for median time to event was based on the Brookmeyer and Crowley method.

    Measured: From the date of randomization until 378 days post-randomization

  3. Overall Survival: ITT Population

    Overall survival was analyzed based on the time from date of randomization to the date of death due to any cause. Participants last known to be alive were censored on the date of last contact. The 95% CI for the median time to event was based on the Brookmeyer and Crowley Method.

    Measured: From the date of randomization until end of study (approximately 6 years)

  4. Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population

    Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific enzyme-linked immunosorbent assay (ELISA).

    Measured: 1 hour post end of infusion on Day 1 of Cycles 1 and 5

  5. Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population

    Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.

    Measured: 1 hour post end of infusion on Day 1 of Cycles 1 and 5

  6. Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population

    Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific ELISA.

    Measured: Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5

  7. Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population

    Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.

    Measured: Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5

  8. Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population

    Two sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) immunoassays, 1 for detecting antibodies against PF-05280014 and the other for detecting antibodies against trastuzumab, were used to analyze ADA samples. Serum samples were first screened for ADA. Any samples that were positive in the screening assay were further analyzed to confirm the positive result and determine the antibody titers. All samples were taken prior to dosing. The number of participants with a positive sample (titer >=1.0) is provided.

    Measured: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 11, 14, 17

  9. Number of Participants With Positive Neutralizing Antibodies (Nab) Prior to Treatment: Safety Population

    Human serum samples testing positive for the presence of ADA (anti-PF-05280014 or anti-trastuzumab-EU) were analyzed for the presence or absence of NAb (neutralizing anti-PF-05280014 or neutralizing anti-trastuzumab-EU antibodies) following a tiered approach using screening and titer determination. The number of participants at baseline (prior to treatment) with a positive NAb sample (titer >=1.48) is provided.

    Measured: Cycle 1 Day 1 (prior to treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2013 (estimated)
  2. Study start24 Feb 2014
  3. Primary completion24 Aug 2016
  4. Study completion27 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989676
Sponsor's protocol ID
B3271002
Other IDs
REFLECTIONS B327-02, 2013-001352-34, B3271002
Status last verified
Jun 2021
First submitted
28 Oct 2013
Last updated
6 Jul 2021
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35133617

  • 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.

    PubMed 31053945

  • 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.

    PubMed 30568294

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-05280014, Paclitaxel and Herceptin® in people with Metastatic Breast Cancer, run by Pfizer at 188 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in Russia, Japan, Brazil, India, Ukraine and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01989676, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in