Spots Global Cancer Trial Database for A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
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Trial Identification
Brief Title: A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
Official Title: A RANDOMIZED, DOUBLE-BLIND PHARMACOKINETIC STUDY OF PF-05280014 PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN VERSUS HERCEPTIN (REGISTERED) PLUS TAXOTERE (REGISTERED) AND CARBOPLATIN FOR THE NEOADJUVANT TREATMENT OF PATIENTS WITH OPERABLE HER2-POSITIVE BREAST CANCER
Study ID: NCT02187744
Conditions
Study Description
Brief Summary: 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%.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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', Lesnoy, Minsk Region, Belarus
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Bacs-Kiskun Megyei Korhaz, Kecskemet, Bacs-kiskun, 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, Milano, 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, Leningrad Region, Russian Federation
"State Budgetary Healthcare Institution ""Republican Clinical Oncological Dispensary of the Ministry, Ufa, Republic Bashkortost, Russian Federation
Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary", Kislino Settlement, Ryshkovskiy Village Council, Russian Federation
"State Budgetary Healthcare Institution of Stavropol Region ""Pyatigorsk Oncological Dispensary""", Pyatigorsk, Stavropol Region, Russian Federation
State Budgetary Healthcare Institution "Volgograd Regional Oncological Dispensary #3", Volzhskiy, Volgograd Region, Russian Federation
SBHI "Regional Oncology Dispensary", Irkutsk, , Russian Federation
Regional Budgetary Healthcare Institution, Kursk, , Russian Federation
FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS, Moscow, , Russian Federation
State Budgetary Institution Of Healthcare, Moscow, , Russian Federation
SBHI of NNR "Clinical diagnostic center", Nizhniy Novgorod, , Russian Federation
State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary", Nizhniy Novgorod, , Russian Federation
Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary", Omsk, , Russian Federation
State Budgetary Educational Institution of Higher Professional Education "North-Western State, Saint-Petersburg, , Russian Federation
Saint-Peterbsurg Clinical Oncological dispensary of Moscow district, Saint-Petersburg, , Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District", Saint-Petersburg, , Russian Federation
LLC RAMSAY Diagnostic RUS, Saint-Petersburg, , Russian Federation
"Federal State Institution ""Scientific Research Institute of Oncology n.a. N.N.Petrov"", Saint-Petersburg, , Russian Federation
Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary", Saint-Petersburg, , Russian Federation
SRBHI "Regional Clinical Oncology Dispensary", Velikiy Novgorod, , Russian Federation
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., Kosice, , 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
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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