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| ID | Type | Description | Link |
|---|---|---|---|
| REFLECTIONS B327-04 | |||
| 2013-004679-11 | EudraCT Number | ||
| REFLECTIONS (B327-04) | Other Identifier | Alias Study Number |
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The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%.
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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, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5. | The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group. | Cycle 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6. | Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation. | Cycles 1 through 6 |
| Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes. |
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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 |
|---|---|---|---|---|---|---|
| Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | 92708 | United States | ||
| Millennium Oncology (Imaging Facility) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30002437 | Derived | Lammers PE, Dank M, Masetti R, Abbas R, Hilton F, Coppola J, Jacobs I. Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer. Br J Cancer. 2018 Aug;119(3):266-273. doi: 10.1038/s41416-018-0147-1. Epub 2018 Jul 13. |
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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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A single participant was randomized but not treated; this participant was included in the ITT population, but not in the Participant Flow, Per Protocol, or Safety populations.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-05280014 | Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study |
|
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| Taxotere® | Drug | Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
|
|
| Paraplatin® | Drug | Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
|
|
| Trastuzumab-EU | Biological | Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles. |
|
| Taxotere® | Drug | Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
|
|
| Paraplatin® | Drug | Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
|
|
Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response. |
| Cycle 6/End of treatment |
| Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor. | ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment. | Cycle 6/End of treatment |
| Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6. | The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive. | Cycles 1 through 6 |
| Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6. | The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive. | Cycles 1 through 6 |
| Kingwood |
| Texas |
| 77339 |
| United States |
| Millennium Oncology (Imaging Facility) | Shenandoah | Texas | 77380 | United States |
| Millennium Oncology | Shenandoah | Texas | 77384 | United States |
| SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov' | Lyasny | Minsk Oblast | 223040 | Belarus |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Bacs-Kiskun Megyei Korhaz | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz. Belgyogyaszati Klinika Onkologiai Reszleg | Budapest | 1083 | Hungary |
| Szent Imre Egyetemi Oktato Korhaz | Budapest | 1115 | Hungary |
| Uzsoki Utcai Korhaz, Onkoradiologia, Sugarterapia Fovarosi Onkoradiologiai Kozpont | Budapest | 1145 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktatokorhaz, | Miskolc | 3526 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet | Szolnok | 5000 | Hungary |
| Division of Medical Senology | Milan | MI | 20141 | Italy |
| Divisione di Oncologia Medica B | Roma | RM | 00144 | Italy |
| IRCCS Istituto Nazionale Tumori Regina Elena (IRE) | Roma | RM | 00144 | Italy |
| Dept. of Surgery | Roma | RM | 00168 | Italy |
| Szpitale Wojewodzkie w Gdyni Sp. z o.o., Oddzial Onkoligii i Radioterapii | Gdynia | 81-519 | Poland |
| Oddzial Chorob Rozrostowych | Lodz | 93-513 | Poland |
| SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | 10-228 | Poland |
| State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary" | Kuzmolovo | Leningradskaya Oblast' | 188663 | Russia |
| "State Budgetary Healthcare Institution ""Republican Clinical Oncological Dispensary of the Ministry | Ufa | Republic Bashkortost | 450054 | Russia |
| Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary" | Kislino Settlement | Ryshkovskiy Village Council | 305524 | Russia |
| "State Budgetary Healthcare Institution of Stavropol Region ""Pyatigorsk Oncological Dispensary""" | Pyatigorsk | Stavropol Kray | 357502 | Russia |
| State Budgetary Healthcare Institution "Volgograd Regional Oncological Dispensary #3" | Volzhsky | Volgograd Oblast | 404130 | Russia |
| SBHI "Regional Oncology Dispensary" | Irkutsk | 664035 | Russia |
| Regional Budgetary Healthcare Institution | Kursk | 305035 | Russia |
| FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS | Moscow | 115478 | Russia |
| State Budgetary Institution Of Healthcare | Moscow | 129301 | Russia |
| SBHI of NNR "Clinical diagnostic center" | Nizhny Novgorod | 603006 | Russia |
| State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary" | Nizhny Novgorod | 603081 | Russia |
| Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary" | Omsk | 644046 | Russia |
| State Budgetary Educational Institution of Higher Professional Education "North-Western State | Saint Petersburg | 195067 | Russia |
| Saint-Peterbsurg Clinical Oncological dispensary of Moscow district | Saint Petersburg | 196247 | Russia |
| Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District" | Saint Petersburg | 196247 | Russia |
| LLC RAMSAY Diagnostic RUS | Saint Petersburg | 197046 | Russia |
| "Federal State Institution ""Scientific Research Institute of Oncology n.a. N.N.Petrov"" | Saint Petersburg | 197758 | Russia |
| Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary" | Saint Petersburg | 198255 | Russia |
| SRBHI "Regional Clinical Oncology Dispensary" | Veliky Novgorod | 173023 | Russia |
| Institute For Oncology And Radiology Of Serbia | Belgrade | 11000 | Serbia |
| Onkologicky ustav sv. Alzbety, s.r.o. | Bratislava | 812 50 | Slovakia |
| Narodny Onkologicky ustav | Bratislava | 833 10 | Slovakia |
| Vychodoslovensky onkologicky ustav, a.s. | Košice | 04191 | Slovakia |
| Municipal Healthcare Institution 'Chernihiv Regional Oncology Dispensary', Mamology Department | Chernihiv | 14029 | Ukraine |
| MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy; | Dnipropetrovsk | 49102 | Ukraine |
| SI "Institute of Medical Radiology n.a.S.P. Hrygoriev of National Academy | Kharkiv | 61024 | Ukraine |
| Munincipal Healthcare Institution"Kharkiv Regional Clinical Oncologic Center | Kharkiv | 61070 | Ukraine |
| Khmelnytskyi Regional Oncologic Dispensary | Khmelnytskyi | 29009 | Ukraine |
| MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council' | Kryvyi Rih | 50048 | Ukraine |
| Lviv State Oncologic Regional Treatment and Diagnostic Center | Lviv | 79031 | Ukraine |
| Municipal Institution 'Odesa Regional Clinical Hospital', Mamology Center | Odesa | 65025 | Ukraine |
| Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department | Sumy | 40005 | Ukraine |
| Vinnytsia Regional Oncology Clinical Dispensary, Chemotherapy Department | Vinnytsia | 21029 | Ukraine |
| Trastuzumab-EU |
Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Treatment |
|
|
All participants who were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-05280014 | Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. |
| BG001 | Trastuzumab-EU | Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | 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 | Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5. | The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group. | All participants who were HER2+ and randomized into the study; and who had received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of participants | Cycle 5 |
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| Secondary | Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6. | Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation. | All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations. | Posted | Mean | Standard Deviation | μg/mL | Cycles 1 through 6 |
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| Secondary | Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes. | Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response. | All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of participants | Cycle 6/End of treatment |
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| Secondary | Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor. | ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment. | All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations. | Posted | Number | 95% Confidence Interval | Percentage of participants | Cycle 6/End of treatment |
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| Secondary | Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6. | The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive. | All participants who received at least 1 dose of study drug. | Posted | Number | Number of participants | Cycles 1 through 6 |
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| Secondary | Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6. | The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive. | All participants who received at least 1 dose of study drug. | Posted | Number | Number of participants | Cycles 1 through 6 |
|
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Serious adverse events were captured from the beginning of the study drug treatment up to 6 months after the last dose. Treatment emergent adverse events were captured from the beginning of the study drug treatment up to 50 days after the last dose.
Treatment emergent adverse events were defined as any adverse event that occurred or any preexisting adverse event that worsened within the reporting time frame.
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| 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 received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. | 7 | 113 | 106 | 113 | ||
| EG001 | Trastuzumab-EU | Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. | 6 | 112 | 106 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA, version 19.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, version 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA, version 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, version 19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, version 19.0 | Systematic Assessment |
|
It was decided that the secondary study objective to explore the relationship between drug exposure and pCR for PF-05280014 versus trastuzumab-EU would not be analyzed.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.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 |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
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| Related adverse event, not serious |
|
| Lost to Follow-up |
|
| Other |
|
| Participant refused continued treatment |
|
| Mean Difference (Final Values) | -1.18 | Standard Error of the Mean | 3.78 | 2-Sided | 95 | -8.59 | 6.23 | Unstratified analysis. | Non-Inferiority or Equivalence | The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough >20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%. |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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