A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
NCT ID: NCT02187744
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
226 participants
INTERVENTIONAL
2014-09-23
2016-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF-05280014
PF-05280014
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.
Taxotere®
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®
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.
Herceptin®
Trastuzumab-EU
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®
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®
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.
Interventions
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PF-05280014
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.
Taxotere®
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®
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
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®
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®
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
* Plan for neoadjuvant chemotherapy.
* Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm.
Exclusion Criteria
* Inflammatory breast cancer.
* Presence of known distant metastases.
* Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Millennium Oncology (Imaging Facility)
Kingwood, Texas, United States
Millennium Oncology (Imaging Facility)
Shenandoah, Texas, United States
Millennium Oncology
Shenandoah, Texas, United States
SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
Lyasny, Minsk Oblast, Belarus
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Bacs-Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz. Belgyogyaszati Klinika Onkologiai Reszleg
Budapest, , Hungary
Szent Imre Egyetemi Oktato Korhaz
Budapest, , Hungary
Uzsoki Utcai Korhaz, Onkoradiologia, Sugarterapia Fovarosi Onkoradiologiai Kozpont
Budapest, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktatokorhaz,
Miskolc, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet
Szolnok, , Hungary
Division of Medical Senology
Milan, MI, Italy
Divisione di Oncologia Medica B
Roma, RM, Italy
IRCCS Istituto Nazionale Tumori Regina Elena (IRE)
Roma, RM, Italy
Dept. of Surgery
Roma, RM, Italy
Szpitale Wojewodzkie w Gdyni Sp. z o.o., Oddzial Onkoligii i Radioterapii
Gdynia, , Poland
Oddzial Chorob Rozrostowych
Lodz, , Poland
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, , Poland
State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"
Kuzmolovo, Leningradskaya Oblast', Russia
"State Budgetary Healthcare Institution ""Republican Clinical Oncological Dispensary of the Ministry
Ufa, Republic Bashkortost, Russia
Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary"
Kislino Settlement, Ryshkovskiy Village Council, Russia
"State Budgetary Healthcare Institution of Stavropol Region ""Pyatigorsk Oncological Dispensary"""
Pyatigorsk, Stavropol Kray, Russia
State Budgetary Healthcare Institution "Volgograd Regional Oncological Dispensary #3"
Volzhsky, Volgograd Oblast, Russia
SBHI "Regional Oncology Dispensary"
Irkutsk, , Russia
Regional Budgetary Healthcare Institution
Kursk, , Russia
FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS
Moscow, , Russia
State Budgetary Institution Of Healthcare
Moscow, , Russia
SBHI of NNR "Clinical diagnostic center"
Nizhny Novgorod, , Russia
State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary"
Nizhny Novgorod, , Russia
Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary"
Omsk, , Russia
State Budgetary Educational Institution of Higher Professional Education "North-Western State
Saint Petersburg, , Russia
Saint-Peterbsurg Clinical Oncological dispensary of Moscow district
Saint Petersburg, , Russia
Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"
Saint Petersburg, , Russia
LLC RAMSAY Diagnostic RUS
Saint Petersburg, , Russia
"Federal State Institution ""Scientific Research Institute of Oncology n.a. N.N.Petrov""
Saint Petersburg, , Russia
Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary"
Saint Petersburg, , Russia
SRBHI "Regional Clinical Oncology Dispensary"
Veliky Novgorod, , Russia
Institute For Oncology And Radiology Of Serbia
Belgrade, , Serbia
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava, , Slovakia
Narodny Onkologicky ustav
Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, , Slovakia
Municipal Healthcare Institution 'Chernihiv Regional Oncology Dispensary', Mamology Department
Chernihiv, , Ukraine
MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;
Dnipropetrovsk, , Ukraine
SI "Institute of Medical Radiology n.a.S.P. Hrygoriev of National Academy
Kharkiv, , Ukraine
Munincipal Healthcare Institution"Kharkiv Regional Clinical Oncologic Center
Kharkiv, , Ukraine
Khmelnytskyi Regional Oncologic Dispensary
Khmelnytskyi, , Ukraine
MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
Kryvyi Rih, , Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, , Ukraine
Municipal Institution 'Odesa Regional Clinical Hospital', Mamology Center
Odesa, , Ukraine
Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
Sumy, , Ukraine
Vinnytsia Regional Oncology Clinical Dispensary, Chemotherapy Department
Vinnytsia, , Ukraine
Countries
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References
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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.
Related Links
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Other Identifiers
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REFLECTIONS B327-04
Identifier Type: -
Identifier Source: secondary_id
2013-004679-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REFLECTIONS (B327-04)
Identifier Type: OTHER
Identifier Source: secondary_id
B3271004
Identifier Type: -
Identifier Source: org_study_id
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