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| ID | Type | Description | Link |
|---|---|---|---|
| REFLECTIONS B327-02 | |||
| 2013-001352-34 | EudraCT Number | ||
| B3271002 | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05280014 | Experimental |
| |
| Herceptin® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05280014 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population | ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size [short axis <10 mm]) or partial response (PR, >=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1. | From the date of randomization until all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Central Connecticut | Plainville | Connecticut | 06062 | United States | ||
| Cancer Center of Central Connecticut |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35133617 | Derived | 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. | |
| 31053945 |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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Participants who fulfilled the inclusion/exclusion criteria were randomly assigned to 1 of the 2 treatments of this study.
A total of 707 participants were randomized to the study. Of these, 5 participants were randomized but did not receive the study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-05280014 | Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Paclitaxel | 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® | 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 | 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. |
|
| From the date of randomization until 378 days post-randomization |
| 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. | From the date of randomization until 378 days post-randomization |
| 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. | From the date of randomization until end of study (approximately 6 years) |
| 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). | 1 hour post end of infusion on Day 1 of Cycles 1 and 5 |
| Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population | Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA. | 1 hour post end of infusion on Day 1 of Cycles 1 and 5 |
| 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. | Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5 |
| 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. | Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5 |
| 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. | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 11, 14, 17 |
| 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. | Cycle 1 Day 1 (prior to treatment) |
| Southington |
| Connecticut |
| 06489 |
| United States |
| Florida Cancer Research Institute | Boca Raton | Florida | 33428 | United States |
| Florida Cancer Research Institute | Plantation | Florida | 33324 | United States |
| COIBA - Centro de Oncologia e Investigacion Buenos Aires | Berazategui | Buenos Aires | B1884BBF | Argentina |
| Instituto De Oncologia De Rosario | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Centro Medico San Roque | San Miguel de Tucumán | Tucumán Province | T4000IAK | Argentina |
| Sanatorio de la Providencia | C.a.b.a | C1050AAK | Argentina |
| CRIO - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | 60336-045 | Brazil |
| Associacao de Combate ao Cancer em Goias - Hospital Araujo Jorge | Goiânia | Goiás | 74605070 | Brazil |
| Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner | Curitiba | Paraná | 81520-060 | Brazil |
| Instituto do Cancer de Londrina - Hospital do Cancer de Londrina - HCL | Londrina | Paraná | 86015-520 | Brazil |
| Associacao Hospital de Caridade Ijui | Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado) | Lajeado | Rio Grande do Sul | 95900-000 | Brazil |
| Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Centro de Pesquisas Oncologicas de Santa Catarina - CEPON | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral | Itajaà | Santa Catarina | 88301-215 | Brazil |
| Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral | Itajaà | Santa Catarina | 88301-220 | Brazil |
| Fundacao Pio XII - Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-650 | Brazil |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-870 | Brazil |
| Clinica Alemana de Temuco | Temuco | Araucania | 4810297 | Chile |
| Centro de Investigacion Clinica SIM | Temuco | Araucania | 4810469 | Chile |
| Administrative office | Temuco | Araucania | 4810561 | Chile |
| Fresenius Kabi Chile Therapia iv | Santiago | RM | 7780050 | Chile |
| Hospital Clinico Vina Del Mar | Viña del Mar | Valparaiso | 2520612 | Chile |
| Instituto Oncologico, Clinica Renaca | Viña del Mar | Valparaiso | 2540364 | Chile |
| Hospital Naval Almirante Nef | V Region | Chile |
| Instituto Oncologico Clinica Renaca | V Region | Chile |
| Onkologicka klinika VFN a 1. LF UK, Fakultni poliklinika | Prague | 128 08 | Czechia |
| General Hospital of Chania "O Agios Georgios" | Chania | Crete | 73300 | Greece |
| Interbalkan European Medical Center | Pylaia | Thessaloniki | 57001 | Greece |
| General Hospital of Athens "Hippokration" | Athens | 11527 | Greece |
| Bacs-Kiskun Megyei Korhaz, Onkoradiologiai Kozpont | Kecskemét | 6000 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias | Miskolc | 3526 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont | Szolnok | 5000 | Hungary |
| Markusovszky Egyetemi Oktatokorhaz | Szombathely | 9700 | Hungary |
| Department of Medicine New Block | Visakhapatnam | Andhra Pradesh | 530002 | India |
| Manipal Hospital | Bengaluru | Karnataka | 560017 | India |
| Manipal Centre for Clinical Research | Manipal | Karnataka | 576104 | India |
| Tata Memorial Centre, Tata Memorial Hospital | Mumbai | Maharashtra | 400012 | India |
| Shatabdi Super Speciality Hospital | Nashik | Maharashtra | 422 005 | India |
| Advanced Centre for Treatment Research and Education in Cancer (ACTREC) | Navi Mumbai | Maharashtra | 401210 | India |
| Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | 411 004 | India |
| Sahyadri Clinical Research & Development Centre | Pune | Maharashtra | 411004 | India |
| Sahyadri Speciality Hospital | Pune | Maharashtra | 411004 | India |
| Acharya Harihar Regional Cancer Center | Cuttack | Odisha | 753007 | India |
| Acharya Tulsi Regional Cancer Treatment and Research Institute | Bikaner | Rajasthan | 334003 | India |
| Meenakshi Mission Hospital and Research Centre | Madurai | Tamil Nadu | 625107 | India |
| MNJ Institute of Oncology & Regional Cancer Center | Hyderabad | Telangana | 500004 | India |
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Fukuoka | 811-1395 | Japan |
| Japan Community Health care Organization Kurume General Hospital | Kurume | Fukuoka | 830-0013 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | 8608556 | Japan |
| Saitama Cancer Center Hospital | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| National Hospital Organization Tokyo Medical Center | Meguro-Ku | Tokyo | 152-8902 | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| Hakuaikai Medical Corporation Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Nakanoshima Osaka Breast Clinic | Osaka | 553-0003 | Japan |
| Osaka Breast Clinic | Osaka | 553-0003 | Japan |
| Shizuoka General Hospital | Shizuoka | 420-8527 | Japan |
| P.Stradins Clinical University Hospital | Riga | LV 1002 | Latvia |
| Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica) | Mexico City | Mexico City | 06760 | Mexico |
| Inter Hosp S.A. de C.V. "Centro Medico Dalinde" | Mexico City | Mexico City | 06760 | Mexico |
| Instituto Nacional de Cancerologia | Mexico City | Mexico City | 14080 | Mexico |
| Oaxaca Site Management Organization S.C. | Oaxaca City | 68000 | Mexico |
| Cancerologia de Queretaro S.C. | Querétaro | 76090 | Mexico |
| Hospital Militar Central | Lima | 11 | Peru |
| INNPARES | Lima | 11 | Peru |
| Resocentro | Lima | 18 | Peru |
| Clinica Anglo Americana | Lima | 27 | Peru |
| Instituto de Oncologia y Radioterapia de la Clinica Ricardo Palma | Lima | 27 | Peru |
| Radiologos S.R.L. | Lima | 27 | Peru |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 34 | Peru |
| Siglo XXI | Lima | 41 | Peru |
| Resocentro | Lima | Lima 18 | Peru |
| Siglo XXI | Lima | Lima 41 | Peru |
| Cebu Doctors' University Hospital | Cebu City | CEBU | 6000 | Philippines |
| The Research Institute at Perpetual Succor Hospital | Cebu City | Central Visayas | 6000 | Philippines |
| Cardinal Santos Medical Center | San Juan City | Mentro Manila | 1502 | Philippines |
| Manila Doctors Hospital | Manila | National Capital Region | 1000 | Philippines |
| Veterans Memorial Medical Center | Quezon City | National Capital Region | 1110 | Philippines |
| University of Philippines Manila-Philippine General Hospital | Manila | NCR | 1000 | Philippines |
| The Medical City | Pasig | NCR | 1605 | Philippines |
| St. Luke's Medical Center | Quezon City | NCR | 1102 | Philippines |
| Manila Doctors Hospital | Manila | 1000 | Philippines |
| COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii | Gdansk | 80-219 | Poland |
| Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii | Gdynia | 81-519 | Poland |
| Centrum Terapii Wspolczesnej | Lodz | 90-242 | Poland |
| SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii | Olsztyn | 10-228 | Poland |
| MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie | Rzeszów | 35-085 | Poland |
| Magodent Sp. z o.o. Oddzial Onkologii Klinicznej/Chemioterapii | Warsaw | 03-291 | Poland |
| Hospital de Braga | Braga | 4710 243 | Portugal |
| Hospital CUF Descobertas | Lisbon | 1998-018 | Portugal |
| Institutul Oncologic Prof. Dr. Ion Chiricuta | Cluj-Napoca | Cluj | 400015 | Romania |
| S.C. Medisprof S.R.L | Cluj-Napoca | Cluj | 400641 | Romania |
| Centrul de Oncologie Sf. Nectarie | Craiova | Dolj | 200347 | Romania |
| SC Oncolab SRL, Oncologie | Craiova | JUD DOLJ | 200385 | Romania |
| Spitalul Universitar de Urgenta, Departamentul Oncologie Medicala | Bucharest | 050098 | Romania |
| Spitalul Clinic Judetean de Urgenta Sibiu | Sibiu | 550245 | Romania |
| Spitalul Judetean de Urgenta "Sf.Ioan cel Nou", Sectia Oncologie | Suceava | 720237 | Romania |
| Spitalul Clinic Municipal de Urgenta Timisoara, Sectia Clinica Oncologie Medicala | Timișoara | 300595 | Romania |
| GBUZ Republican Clinical Hospital n.a. G.F. Kuvatova | Ufa | Bashkortostan Republic | 450005 | Russia |
| Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Baskortostan Republic | Ufa | Bashkortostan Republic | 450054 | Russia |
| State Healthcare Institution, Republican Clinical Oncology Dispensary of the Ministry of | Ufa | Bashkortostan Republic | 450054 | Russia |
| Republic Clinical Hospital of Emergency Care | Grozny | Chechenkaya Republic | 364020 | Russia |
| State Healthcare Institution Kursk Regional Oncological Dispensary of the Healthcare Committee | Kislino Settlement | Kursk Oblast | 305524 | Russia |
| State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary" | Kuzmolovo, Vsevolozhskiy | Leningradskaya Oblast' | 188663 | Russia |
| FSBSI Russian Cancer Research Center n.a. N.N.Blokhin | Moscow | NAP | 115478 | Russia |
| GBUZ of Perm region "Perm regional oncology dispensary" | Perm | NAP | 614066 | Russia |
| Federal State Budgetary Institution ¿National Medical Research Oncology Centre named after N.N. | Saint Petersburg | Pos.pesochny | 197758 | Russia |
| State Budgetary Healthcare Institution ''Republic Oncological Dispensary'' | Petrozavodsk | Republic of Karelia | 185002 | Russia |
| State budget institution of healthcare of Mordovia Republic "Republic Oncology Dispensary" | Saransk | Respublika Mordoviya | 430032 | Russia |
| Rostov Research Institute of Oncology | Rostov-on-Don | Rostov Oblast | 344037 | Russia |
| Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology) | Poselok Pesochny | Sankt-Peterburg | 197758 | Russia |
| Private medical institution Euromedservice | Pushkin | Sankt-Peterburg | 196603 | Russia |
| LLC Medekspert | Kislovodsk | Stavropol Kray | 357700 | Russia |
| Federal State Budgetary Healthcare Institution of "Clinical Hospital #101 of Federal Medical and | Lermontov | Stavropol Kray | 357340 | Russia |
| Centre of Specialized kinds of Medical Care of Pyatigorsk city | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| State Budgetary Healthcare Institution of Stavropol Region Pyatigorsk Oncology Dispensary | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| LLC Novaya Clinica | Pyatigorsk | Stavropol Kray | 357519 | Russia |
| Pyatigorsk City Hospital #2 | Pyatigorsk | Stavropol Kray | 357538 | Russia |
| Stavropol Regional Hospital for War Veterans | Pyatigorsk | Stavropol Kray | 357563 | Russia |
| State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary | Volzhsky | Volgograd Oblast | 404130 | Russia |
| GBUZ Arkhangelsk Regional Clinical Oncological dispensary | Arkhangelsk | 163045 | Russia |
| State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncological Dispensary" | Chelyabinsk | 454087 | Russia |
| "Regional Budgetary Healthcare Institution ""Ivanovo Regional Oncology Dispensary""" | Ivanovo | 153040 | Russia |
| SBIH of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary" | Kaluga | 248007 | Russia |
| GBUZ "Regional Oncology Dispensary #2" | Magnitogorsk | 455001 | Russia |
| Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N. Blokhin" of | Moscow | 115478 | Russia |
| LLC VitaMed | Moscow | 121309 | Russia |
| LLC VitaMed | Moscow | 129515 | Russia |
| State Budgetary Healthcare Institution "Nizhniy Novgorod Regional Oncological Dispensary" | Nizhny Novgorod | 603081 | Russia |
| "BIH of Omsk Region ""Clinical oncological dispensary""" | Omsk | 644046 | Russia |
| Budgetary Institution of Healthcare of Orel region "Orel oncological dispensary" | Oryol | 302020 | Russia |
| SBEI HPE RyazSMU of MoH of the Russian Federation based on SBI of Ryazan Region "Regional CLinical | Ryazan | 390011 | Russia |
| SBI "North-Western State Medical University n.a. I. I. Mechnikov" of the MoH of the Russian | Saint Petersburg | 195067 | Russia |
| Non-state healthcare agency Road Clinical Hospital PLC Russian Railways | Saint Petersburg | 195271 | Russia |
| Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District" | Saint Petersburg | 196247 | Russia |
| SBEI of HPE "First Saint Petersburg State Medical University | Saint Petersburg | 197022 | Russia |
| Non-State Healthcare Institution "Road Clinical Hospital at Saratov II Station" | Saratov | 410004 | Russia |
| State Budgetary Healthcare Institution of Stavropol region "Stavropol regional clinical oncology | Stavropol | 355047 | Russia |
| Institute for Oncology and Radiology of Serbia | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| Oncology Institute of Vojvodina | Kamenitz | 21204 | Serbia |
| Clinic of Oncology-Clinical Center Nis | Niš | 18000 | Serbia |
| Onkologicky ustav sv. Alzbety, s.r.o. | Bratislava | 812 50 | Slovakia |
| Narodny Onkologicky Ustav | Bratislava | 833 10 | Slovakia |
| GVI Oncology, Langenhoven Drive Oncology Centre | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| wits Clinical Research | Joannesburg | Gauteng | 2193 | South Africa |
| The Medical Oncology Centre of Rosebank | Johannesburg | Gauteng | 2196 | South Africa |
| Sandton Oncology Centre | Johannesburg | Gauteng | 2199 | South Africa |
| *Department of Medical Oncology, University of Pretoria & Steve Biko Academic Hospitals Complex | Pretoria | Gauteng | 0002 | South Africa |
| Eastleigh Breast Care Centre | Pretoria | Gauteng | 0081 | South Africa |
| Cape Town Oncology Trials | Kraaifontein | Western Cape | 7570 | South Africa |
| GVI Rondebosch Oncology Centre-Rondebosch Medical Centre | Rondebosch | Western Cape | 7700 | South Africa |
| Ulsan University Hospital | Ulsan | Korea | 44033 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| National Cancer Centre | Goyang-si | 10408 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| National Cancer Institute | Ratchathewi | Bangkok | 10400 | Thailand |
| Udonthani Cancer Hospital | Amphur Muang | Udonthani | 41330 | Thailand |
| Faculty of Medicine, Chulongkorn University, Medical Oncology Unit | Bangkok | 10330 | Thailand |
| Baskent University School of Medicine Adana Hospital | Adana | 01120 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi | Ankara | 06100 | Turkey (Türkiye) |
| Uludag Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali | Bursa | 16059 | Turkey (Türkiye) |
| Dicle University Medical Faculty | Diyarbakır | 21080 | Turkey (Türkiye) |
| Gaziantep University Medical Faculty | Gaziantep | 27310 | Turkey (Türkiye) |
| Istanbul Universitesi Onkoloji Enstitusu | Istanbul | 34093 | Turkey (Türkiye) |
| Municipal Institution "Chernivtsi Regional Clinical Oncology Center", Outpatient Department | Chernivtsi | 58013 | Ukraine |
| Municipal Non-Profit Enterprise City Clinical Hospital No.4of Dnipro Regional Council, Department of | Dnipro | 49102 | Ukraine |
| SI Institute of Medical Radiology n.a.S.P. Ilrygoriev of National Academy of Medical Science of | Kharkiv | 61024 | Ukraine |
| Communal Non-Profit Enterprise "Regional Center of Oncology" | Kharkiv | 61070 | Ukraine |
| Khmelnytskyi Regional Oncologic Dispensary | Khmelnytskyi | 29009 | Ukraine |
| Municipal Enterprise 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council' | Kryvyi Rih | 50048 | Ukraine |
| Municipal Non-Profit Enterprise of Kyiv Regional Council "Kyiv Regional Oncology Dispensary" | Kyiv | 04107 | Ukraine |
| Lviv State Oncologic Regional Treatment and Diagnostic Center | Lviv | 79031 | Ukraine |
| Municipal Institution Odesa Regional Clinical Hospital, Mammology Center | Odesa | 65025 | Ukraine |
| Zakarpattia Regional Clinical Oncological Center | Uzhhorod | 88014 | Ukraine |
| Municipal Non-profit Enterprise Podilsk Regional Oncology Centre of Vinnytsia Regional Council | Vinnytsia | 21029 | Ukraine |
| Derived |
| 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. |
| 30568294 | Derived | 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. |
| FG001 | Trastuzumab-EU | Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could 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. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline analysis population was based on the safety population, which was defined as all participants who were randomized and treated with study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-05280014 | Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could 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. |
| BG001 | Trastuzumab-EU | Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The ITT population was defined as all participants who were randomized to study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
|
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|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population was defined as all participants who were randomized to study drug. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until 378 days post-randomization |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population was defined as all participants who were randomized to study drug. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until 378 days post-randomization |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population was defined as all participants who were randomized to study drug. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until end of study (approximately 6 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "number analyzed (n)" signifies participants evaluable at specified time points only. | Posted | Median | Full Range | mcg/mL | 1 hour post end of infusion on Day 1 of Cycles 1 and 5 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "n" signifies participants evaluable at specified time points only. | Posted | Median | Full Range | mcg/mL | 1 hour post end of infusion on Day 1 of Cycles 1 and 5 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PK population.Here "n" signifies participants evaluable at specified time points only.The Cycle 17 Day 1 (C17D1) samples summarized previously at PCD (Week 33) fell outside of cut-off used for final analysis (Week 53), to limit data for up to 1-year post randomization, which was more conservative from previous Week 33 analysis. While comparing data between Week 33 and Week 53, there was a significant drop off in number of samples summarized at C17D1 and was down to zero for this outcome measure. | Posted | Median | Full Range | mcg/mL | Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "n" signifies participants evaluable at specified time points only. | Posted | Median | Full Range | mcg/mL | Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population was used for analysis, included all participants who received at least 1 dose of study drug. Here "n" signifies participants evaluable at specified time points only. | Posted | Count of Participants | Participants | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 11, 14, 17 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population was used for analysis, included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Cycle 1 Day 1 (prior to treatment) |
|
Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-05280014 | Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could 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. | 61 | 349 | 67 | 349 | 337 | 349 |
| EG001 | Trastuzumab-EU | Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could 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. | 67 | 353 | 69 | 353 | 334 | 353 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cyst rupture | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Thyroiditis subacute | Endocrine disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasopharyngeal neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cerebral venous sinus thrombosis | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598430 | PF-05280014 |
| D017239 | Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 65 to 84 |
|
| ≥85 |
|
| Male |
|
| OG001 | Trastuzumab-EU | Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could 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. |
|
|
|
| OG001 | Trastuzumab-EU | Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could 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. |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
| Participants |
|
|
| OG001 | Trastuzumab-EU | Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could 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. |
|
|
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could 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. |
|
|