Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 650 for:    Russian Federation | Chile

A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01989676
Recruitment Status : Active, not recruiting
First Posted : November 21, 2013
Results First Posted : January 23, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Biological: PF-05280014 Drug: Paclitaxel Biological: Herceptin® Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 707 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 24, 2014
Actual Primary Completion Date : August 24, 2016
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: PF-05280014 Biological: 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.
Other Name: Trastuzumab-Pfizer

Drug: 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.

Active Comparator: Herceptin® Biological: 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.
Other Name: Trastuzumab (EU)

Drug: 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.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population [ Time Frame: From the date of randomization until the cutoff date of 24 August 2016 when all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit. ]
    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 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.


Secondary Outcome Measures :
  1. One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population [ Time Frame: From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016. ]
    One (1)-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. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox's proportional hazards model.

  2. Duration of Response (DOR) Per Central Radiology Assessments: ITT Population [ Time Frame: From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016. ]
    DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD, or to 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. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox's proportional hazards model.

  3. One-year Survival Rate: ITT Population [ Time Frame: From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016. ]
    One-year survival rate was analyzed based on the time from date of randomization to the date of death due to any cause while the participant was on the study. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox's proportional hazards model.

  4. Serum Peak (1 Hour Post End of Infusion) Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population [ Time Frame: Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016 ]
    Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific enzyme-linked immuno-sorbent assay (ELISA).

  5. Serum Peak (1 Hour Post End of Infusion) Concentration of Trastuzumab-EU at Selected Cycles: PK Population [ Time Frame: Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016 ]
    Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.

  6. Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population [ Time Frame: Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records. ]
    Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific ELISA.

  7. Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population [ Time Frame: Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records. ]
    Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.

  8. Anti-Drug Antibodies (ADA) Incidence: Safety Population [ Time Frame: Available data from Baseline through Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records. ]
    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.

  9. Neutralizing Antibodies (Nab) Incidence at Cycle 1 Day 1 Prior to Treatment: Safety Population [ Time Frame: Available data from Baseline to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records. ]
    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. All samples at baseline (prior to treatment) or post-treatment were taken prior to dosing. All participants with the exception of 1 participant in the trastuzumab-EU group tested negative for ADA (titer <1.00) from Cycle 1, Day 1 post-treatment through Cycle 17, Day 1. The corresponding NAb result for this Cycle 17, Day 1 ADA positive sample was not yet available; thus, not reported. The number of participants at Baseline (prior to treatment) with a positive NAb sample (titer≥1.48) is provided.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989676


  Hide Study Locations
Locations
Layout table for location information
United States, Connecticut
Cancer Center of Central Connecticut
Plainville, Connecticut, United States, 06062
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489
United States, Florida
Florida Cancer Research Institute
Boca Raton, Florida, United States, 33428
Florida Cancer Research Institute
Plantation, Florida, United States, 33324
Argentina
COIBA - Centro de Oncologia e Investigacion Buenos Aires
Berazategui, Buenos Aires, Argentina, B1884BBF
Instituto De Oncologia De Rosario
Rosario, Santa FE, Argentina, S2000KZE
Centro Medico San Roque
San Miguel de Tucuman, Tucuman, Argentina, T4000IAK
Sanatorio de la Providencia
C.a.b.a, Argentina, C1050AAK
Brazil
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, CE, Brazil, 60336-045
Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge
Goiania, GO, Brazil, 74605070
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Parana, Brazil, 81520-060
Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL
Londrina, Parana, Brazil, 86015-520
Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)
Lajeado, RIO Grande DO SUL, Brazil, 95900-000
Associacao Hospital de Caridade Ijui
Ijui, RS, Brazil, 98700-000
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia
Porto Alegre, RS, Brazil, 90610-000
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
Itajai, Santa Catarina, Brazil, 88301-215
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, SAO Paulo, Brazil, 14784-400
Centro de Pesquisas Oncologicas de Santa Catarina - CEPON
Florianopolis, SC, Brazil, 88034-000
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral
Itajai, SC, Brazil, 88301-220
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo Andre, SP, Brazil, 09060-650
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo Andre, SP, Brazil, 09060-870
Chile
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Region DE LA Araucania, Chile, 4810469
Administrative office
Temuco, Region DE LA Araucania, Chile, 4810561
Fresenius Kabi Chile Therapia iv
Santiago, RM, Chile, 7780050
Hospital Clinico Vina Del Mar
Vina del Mar, V Region Valparaiso, Chile, 2520612
Centro de Investigacion Clinica SIM
Temuco, Chile, 4810469
Instituto Oncologico, Clinica Renaca
V Region, Chile, 2540364
Hospital Naval Almirante Nef
V Region, Chile
Instituto Oncologico Clinica Renaca
V Region, Chile
Czechia
Onkologicka klinika VFN a 1. LF UK, Fakultni poliklinika
Praha 2, Czechia, 128 08
Greece
General Hospital of Chania "O Agios Georgios"
Chania, Crete, Greece, 73300
Interbalkan European Medical Center
Pylaia, Thessaloniki, Greece, 57001
General Hospital of Athens "Hippokration"
Athens, Greece, 11527
Hungary
Bacs-Kiskun Megyei Korhaz, Onkoradiologiai Kozpont
Kecskemet, Hungary, 6000
Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias
Miskolc, Hungary, 3526
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont
Szolnok, Hungary, 5000
Markusovszky Egyetemi Oktatokorhaz
Szombathely, Hungary, 9700
India
Department of Medicine New Block
Visakhapatnam, Andhra Pradesh, India, 530002
Manipal Hospital
Bangalore, Karnataka, India, 560017
Manipal Centre for Clinical Research
Manipal, Karnataka, India, 576104
Tata Memorial Centre, Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Shatabdi Super Speciality Hospital
Nashik, Maharashtra, India, 422 005
Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharashtra, India, 401210
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India, 411 004
Sahyadri Clinical Research & Development Centre
Pune, Maharashtra, India, 411004
Sahyadri Speciality Hospital
Pune, Maharashtra, India, 411004
Acharya Harihar Regional Cancer Center
Cuttack, Odisha, India, 753007
Acharya Tulsi Regional Cancer Treatment and Research Institute
Bikaner, Rajasthan, India, 334003
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil NADU, India, 625107
MNJ Institute of Oncology & Regional Cancer Center
Hyderabad, Telangana, India, 500004
Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
National Hospital Organization Kyushu Cancer Center
Fukuoka-Shi, Fukuoka, Japan, 811-1395
Japan Community Health care Organization Kurume General Hospital
Kurume-city, Fukuoka, Japan, 830-0013
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Kumamoto University Hospital
Kumamoto-city, Kumamoto, Japan, 8608556
Saitama Cancer Center Hospital
Kitaadachi-gun, Saitama, Japan, 362-0806
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, Japan, 152-8902
Showa University Hospital
Shinagawa-ku, Tokyo, Japan, 142-8666
Chiba Cancer Center
Chiba, Japan, 260-8717
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Japan, 892-0833
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Nakanoshima Osaka Breast Clinic
Osaka, Japan, 553-0003
Osaka Breast Clinic
Osaka, Japan, 553-0003
Shizuoka General Hospital
Shizuoka, Japan, 420-8527
Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
National Cancer Centre
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Ulsan University Hospital
Ulsan, Korea, Korea, Republic of, 44033
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Kyungpook National University Hospital (KNUH)
Daegu, Korea, Republic of, 702 210
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Korea University Guro Hospital
Seoul, Korea, Republic of, 08308
Latvia
P.Stradins Clinical University Hospital
Riga, Latvia, LV 1002
Mexico
Instituto Nacional de Cancerologia
Mexico City, Distrito Federal, Mexico, 14080
Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)
Mexico, Distrito Federal, Mexico, 06760
Inter Hosp S.A. de C.V. "Centro Medico Dalinde"
Mexico, Distrito Federal, Mexico, 06760
Oaxaca Site Management Organization S.C.
Oaxaca, Mexico, 68000
Cancerologia de Queretaro S.C.
Queretaro, Mexico, 76090
Peru
Instituto Nacional de Enfermedades Neoplasicas
Surquillo, Lima, Peru, 34
Hospital Militar Central
Lima, Peru, 11
INNPARES
Lima, Peru, 11
Resocentro
Lima, Peru, 18
Clinica Anglo Americana
Lima, Peru, 27
Instituto de Oncologia y Radioterapia de la Clinica Ricardo Palma
Lima, Peru, 27
Radiologos S.R.L.
Lima, Peru, 27
Siglo XXI
Lima, Peru, 41
Resocentro
Lima, Peru, Lima 18
Siglo XXI
Lima, Peru, Lima 41
Philippines
Cebu Doctors' University Hospital
Cebu City, Cebu, Philippines, 6000
Manila Doctors Hospital
Manila, Metro Manila, Philippines, 1000
Veterans Memorial Medical Center
Quezon City, Metro Manila, Philippines, 1110
Cardinal Santos Medical Center
San Juan City, Metro Manila, Philippines, 1502
University of Philippines Manila-Philippine General Hospital
Manila, NCR, Philippines, 1000
The Medical City
Pasig City, NCR, Philippines, 1605
St. Luke's Medical Center
Quezon City, NCR, Philippines, 1102
Perpetual Succour Hospital
Cebu City, Region VII, Philippines, 6000
Poland
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
Gdynia, Pomorskie, Poland, 81 519
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, Poland, 80-219
Centrum Terapii Wspolczesnej
Lodz, Poland, 90-242
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii
Olsztyn, Poland, 10-228
MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie
Rzeszow, Poland, 35-085
Magodent Sp. z o.o. Oddzial Onkologii Klinicznej/Chemioterapii
Warszawa, Poland, 03-291
Portugal
Hospital de Braga
Braga, Portugal, 4710-243
Hospital CUF Descobertas
Lisboa, Portugal, 1998-018
Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, Romania, 400015
S.C. Medisprof S.R.L
Cluj-Napoca, Cluj, Romania, 400641
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, Romania, 200347
SC Oncolab SRL, Oncologie
Craiova, Jud Dolj, Romania, 200385
Spitalul Universitar de Urgenta, Departamentul Oncologie Medicala
Bucuresti, Romania, 050098
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Romania, 550245
Spitalul Judetean de Urgenta "Sf.Ioan cel Nou", Sectia Oncologie
Suceava, Romania, 720237
Spitalul Clinic Municipal de Urgenta Timisoara, Sectia Clinica Oncologie Medicala
Timisoara, Romania, 300595
Russian Federation
Republic Clinical Hospital of Emergency Care
Grozny, Chechenkaya Republic, Russian Federation, 364020
State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee
Kislino Settlement, Kursk, Russian Federation, 305524
State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"
Kuzmolovo, Vsevolozhskiy, Leningrad Region, Russian Federation, 188663
Federal State Budgetary Institution ¿National Medical Research Oncology Centre named after N.N.
Saint-Petersburg, Pos.pesochny, Russian Federation, 197758
Federal State Budgetary Institution "Scientific Research Institute of Oncology n.a. N.N. Petrov " of
Saint-Petersburg, Poselok Pescochny, Russian Federation, 197758
State Healthcare Institution, Republican Clinical Oncology Dispensary of the Ministry of
Ufa, Republic OF Bashkortostan, Russian Federation, 450054
GBUZ Republican Clinical Hospital n.a. G.F. Kuvatova
Ufa, Republic OF Baskortostan, Russian Federation, 450005
Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Baskortostan Republic
Ufa, Republic OF Baskortostan, Russian Federation, 450054
State Budgetary Healthcare Institution ''Republic Oncological Dispensary''
Petrozavodsk, Republic OF Karelia, Russian Federation, 185002
State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary"
Saransk, Republic OF Mordovia, Russian Federation, 430032
Rostov Research Institute of Oncology
Rostov-on-Don, Rostov Region, Russian Federation, 344037
Private medical institution Euromedservice
Pushkin, Saint Petersburg, Russian Federation, 196603
Federal State Budgetary Institution "Russian Research Center for Radiology and Surgical Technologies
Pesochniy, Saint-petersburg, Russian Federation, 197758
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
Poselok Pesochny, Saint-petersburg, Russian Federation, 197758
GBUZ SK Pyatigorsk oncology dispensary
Pyatigorsk, Stavropol AREA, Russian Federation, 357502
LLC Medekspert
Kislovodsk, Stavropol Region, Russian Federation, 357700
Federal State Budgetary Healthcare Institution of "Clinical Hospital #101 of Federal Medical and
Lermomtov, Stavropol Region, Russian Federation, 357340
Centre of Specialized kinds of Medical Care of Pyatigorsk city
Pyatigorsk, Stavropol Region, Russian Federation, 357502
State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncological Dispensary
Pyatigorsk, Stavropol Region, Russian Federation, 357502
LLC Novaya Clinica
Pyatigorsk, Stavropol Region, Russian Federation, 357519
Pyatigorsk City Hospital #2
Pyatigorsk, Stavropol Region, Russian Federation, 357538
Stavropol Regional Hospital for War Veterans
Pyatigorsk, Stavropol Region, Russian Federation, 357563
Medical Center "Chernozemye" (City Clinical Hospital #1 n.a. C.Z.Fishera)
Volzhskiy, Volgograd Region, Russian Federation, 404120
State Budgetary Healthcare Institution "City Clinical Hospital #1 n.a. C.Z.Fishera", Volzhskiy
Volzhskiy, Volgograd Region, Russian Federation, 404120
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volzhskiy, Volgograd Region, Russian Federation, 404130
GBUZ Arkhangelsk Regional Clinical Oncological dispensary
Arkhangelsk, Russian Federation, 163045
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Russian Federation, 454076
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary"
Chelyabinsk, Russian Federation, 454087
"Regional Budgetary Healthcare Institution ""Ivanovo Regional Oncology Dispensary"""
Ivanovo, Russian Federation, 153040
SBIH of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"
Kaluga, Russian Federation, 248007
GBUZ "Regional Oncology Dispensary #2"
Magnitogorsk, Russian Federation, 455001
Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N. Blokhin" of
Moscow, Russian Federation, 115478
FSBSI Russian Cancer Research Center n.a. N.N.Blokhin
Moscow, Russian Federation, 115478
LLC VitaMed
Moscow, Russian Federation, 121309
LLC VitaMed
Moscow, Russian Federation, 129515
Nizhniy Novgorod Regional Clinical Diagnostic Center
Nizhniy Novgorod, Russian Federation, 603006
State Budgetary Healthcare Institution "Nizhniy Novgorod Regional Oncological Dispensary"
Nizhniy Novgorod, Russian Federation, 603081
Clinical Hospital #1 POMC
Nizhniy Novgorod, Russian Federation, 603109
Regional Diagnostic Center
Nizhniy Novgorod, Russian Federation, 603126
"BIH of Omsk Region ""Clinical oncological dispensary"""
Omsk, Russian Federation, 644046
Budgetary Institution of Healthcare of Orel region "Orel oncological dispensary"
Orel, Russian Federation, 302020
GBUZ of Perm region "Perm regional oncology dispensary"
Perm, Russian Federation, 614066
State Budgetary Healthcare Institution "Republican Hospital n.a.V.A,Baranov"
Petrozavodsk, Russian Federation, 185019
SBEI HPE RyazSMU of MoH of the Russian Federation based on SBI of Ryazan Region "Regional CLinical
Ryazan, Russian Federation, 390011
FSBI "Scientific Research Institute of oncology n.a.N.N.Petrov"of ministry of health of the Russian
Saint Petersburg,, Russian Federation, 197758
Laboratory of Saint-Petersburg state Budgetary Healthcare Institution "oncological Dispensary of
Saint Petersburg, Russian Federation, 196247
SBEI of HPE "First Saint Petersburg State Medical University
Saint Petersburg, Russian Federation, 197022
LLC Ramsay Diagnostics RUS
Saint Petersburg, Russian Federation, 197046
BioEq
Saint Petersburg, Russian Federation, 197342
DTC IIBS Diagnostic treatment Centre
Saint-Petersburg, Russian Federation, 191114
SBI "North-Western State Medical University n.a. I. I. Mechnikov" of the MoH of the Russian
Saint-Petersburg, Russian Federation, 195067
Non-state healthcare agency Road Clinical Hospital PLC Russian Railways
Saint-Petersburg, Russian Federation, 195271
Saint-Petersburg State Budgetary Healthcare Institution "City Hospital 26"
Saint-Petersburg, Russian Federation, 196247
Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"
Saint-Petersburg, Russian Federation, 196247
Local Laboratory at FSBI National Medical Research Center of Oncology n.a. N.N. Petrov
Saint-Petersburg, Russian Federation, 197758
Federal State Budgetary Institution
Saratov, Russian Federation, 410002
Non-State Healthcare Institution "Road Clinical Hospital at Saratov II Station"
Saratov, Russian Federation, 410004
State Budgetary Healthcare Institution of Stavropol region "Stavropol regional clinical oncology
Stavropol, Russian Federation, 355047
State Budgetary Healthcare Institution "Volgograd Regional Clinical Dispensary #1", Volgograd
Volgograd, Russian Federation, 400138
Volgograd Regional Oncology Dispansary # 3
Volzhskiy, Russian Federation, 404130
Serbia
Institute for Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Military Medical Academy
Belgrade, Serbia, 11000
Clinic of Oncology-Clinical Center Nis
Nis, Serbia, 18000
Oncology Institute of Vojvodina
Sremska Kamenica, Serbia, 21204
Slovakia
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava, Slovakia, 812 50
Narodny Onkologicky Ustav
Bratislava, Slovakia, 833 10
South Africa
GVI Oncology, Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern CAPE, South Africa, 6045
Drs Bloch and Partners (Sandton Radiology)
Johannesburg, Gauteng, South Africa, 2010
Dr Louis Sulman & Partners Diagnostic Radiologist
Johannesburg, Gauteng, South Africa, 2132
Dr Louis Sulman & Partners, Diagnostic Radiologists
Johannesburg, Gauteng, South Africa, 2132
Dr Leonard Steingo
Johannesburg, Gauteng, South Africa, 2146
Dr PA Jennings
Johannesburg, Gauteng, South Africa, 2146
Dr Ann McKnight, Nuclear Medicine Specialist
Johannesburg, Gauteng, South Africa, 2192
Dr Darryl Smith
Johannesburg, Gauteng, South Africa, 2192
Dr RA Garda
Johannesburg, Gauteng, South Africa, 2192
Dr. Darryl Smith
Johannesburg, Gauteng, South Africa, 2192
Wits Clinical Research
Johannesburg, Gauteng, South Africa, 2193 South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa, 2196
Professor M D T Vangu-Nuclear Medicine department
Parktown, Gauteng, South Africa, 2193
*Department of Medical Oncology, University of Pretoria & Steve Biko Academic Hospitals Complex
Pretoria, Gauteng, South Africa, 0002
Eastleigh Breast Care Centre
Pretoria, Gauteng, South Africa, 0081
Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg,gauteng, South Africa, 2193
Dr. Lior Sareli Inc.
Cape Town, Western CAPE, South Africa, 7560
Dr. Pierre Roux
Cape Town, Western CAPE, South Africa, 7560
Drs Schnetler, Corbett & Partners Inc.
Cape Town, Western CAPE, South Africa, 7560
GVI Oncology Clinical Research Unit, Cape Gate Oncology Centre
Kraaifontein, Western CAPE, South Africa, 7570
Dr. H. Morkel
Parow, Western CAPE, South Africa, 7500
GVI Rondebosch Oncology Centre-Rondebosch Medical Centre
Rondebosch, Western CAPE, South Africa, 7700
Sandton Oncology Centre
Gauteng, South Africa, 2199
Thailand
Vipharam Praket Hospital
Bangkapi, Bangkok, Thailand, 10240
Phachachuen Imaging Center
Jatujak, Bangkok, Thailand, 10900
Ratchavipa MRI Center
Jatujak, Bangkok, Thailand, 10900
National Cancer Institute
Ratchathewi, Bangkok, Thailand, 10400
Samitivej Srinakarin Hospital
Suanluang, Bangkok, Thailand, 10250
Pahonpol Payuha Sena Hospital
Muang, Kanchanaburi, Thailand, 71000
Nonthavej Hospital
Muang, Nonthaburi, Thailand, 11000
Udonthani Cancer Hospital
Amphur Muang, Udonthani, Thailand, 41330
Faculty of Medicine, Chulongkorn University, Medical Oncology Unit
Bangkok, Thailand, 10330
Srinagarind Hospital
Khon Khaen, Thailand, 40002
Bangkok Hospital Udon
Udonthani, Thailand, 41000
Turkey
Hacettepe Universitesi Tip Fakultesi
Ankara, Sihhiye, Turkey, 06100
Baskent University School of Medicine Adana Hospital
Adana, Turkey, 01120
Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
Bursa, Turkey, 16059
Dicle University Medical Faculty
Diyarbakir, Turkey, 21080
Gaziantep University Medical Faculty
Gaziantep, Turkey, 27310
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, Turkey, 34093
Ukraine
Municipal Institution "Chernivtsi Regional Clinical Oncology Center", Outpatient Department
Chernivtsi, Ukraine, 58013
MI City Dnipropetrovsk Multi-field Clin. Hospital 4 of DRC, SI Dnipropetrovsk MA of MoH of Ukr
Dnipropetrovsk, Ukraine, 49102
SI Institute of Medical Radiology n.a.S.P. Hrygoriev of National Academy of Medical Science of Ukrai
Kharkiv, Ukraine, 61024
Communal Non-Profit Enterprise Regional Center of Oncology-Chest Oncosurgery department, city of
Kharkiv, Ukraine, 61070
Khmelnytskyi Regional Oncologic Dispensary
Khmelnytskyi, Ukraine, 29009
Municipal Institution Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
Kryvyi Rih, Ukraine, 50048
Municipal Institution of Kyiv Regional Council Kyiv Regional Oncology Center-Center of Mammary Gland
Kyiv, Ukraine, 04107
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, Ukraine, 79031
Municipal Institution Odesa Regional Clinical Hospital, Mammology Center
Odesa, Ukraine, 65025
Zakarpattia Regional Clinical Oncological Center
Uzhgorod, Ukraine, 88014
Vinnytsia Regional Clinical Oncology Dispensary
Vinnytsia, Ukraine, 21029
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01989676     History of Changes
Other Study ID Numbers: B3271002
REFLECTIONS B327-02
2013-001352-34 ( EudraCT Number )
B3271002 ( Other Identifier: Alias Study Number )
First Posted: November 21, 2013    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
Phase 3
trastuzumab
Breast Neoplasms
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological