Breast Cancer Clinical Trial

A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)

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%.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed HER2 overexpressing invasive breast cancer.
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:

Bilateral breast cancer.
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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

226

Study ID:

NCT02187744

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 50 Locations for this study

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Compassionate Cancer Care Medical Group, Inc.
Fountain Valley California, 92708, United States
Millennium Oncology (Imaging Facility)
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'
Lesnoy Minsk Region, 22304, Belarus
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Bacs-Kiskun Megyei Korhaz
Kecskemet Bacs-kiskun, 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
Milano 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 , 81-51, Poland
Oddzial Chorob Rozrostowych
Lodz , 93-51, Poland
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn , 10-22, Poland
State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"
Kuzmolovo Leningrad Region, 18866, Russian Federation
"State Budgetary Healthcare Institution ""Republican Clinical Oncological Dispensary of the Ministry
Ufa Republic Bashkortost, 45005, Russian Federation
Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary"
Kislino Settlement Ryshkovskiy Village Council, 30552, Russian Federation
"State Budgetary Healthcare Institution of Stavropol Region ""Pyatigorsk Oncological Dispensary"""
Pyatigorsk Stavropol Region, 35750, Russian Federation
State Budgetary Healthcare Institution "Volgograd Regional Oncological Dispensary #3"
Volzhskiy Volgograd Region, 40413, Russian Federation
SBHI "Regional Oncology Dispensary"
Irkutsk , 66403, Russian Federation
Regional Budgetary Healthcare Institution
Kursk , 30503, Russian Federation
FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS
Moscow , 11547, Russian Federation
State Budgetary Institution Of Healthcare
Moscow , 12930, Russian Federation
SBHI of NNR "Clinical diagnostic center"
Nizhniy Novgorod , 60300, Russian Federation
State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary"
Nizhniy Novgorod , 60308, Russian Federation
Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary"
Omsk , 64404, Russian Federation
State Budgetary Educational Institution of Higher Professional Education "North-Western State
Saint-Petersburg , 19506, Russian Federation
Saint-Peterbsurg Clinical Oncological dispensary of Moscow district
Saint-Petersburg , 19624, Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"
Saint-Petersburg , 19624, Russian Federation
LLC RAMSAY Diagnostic RUS
Saint-Petersburg , 19704, Russian Federation
"Federal State Institution ""Scientific Research Institute of Oncology n.a. N.N.Petrov""
Saint-Petersburg , 19775, Russian Federation
Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary"
Saint-Petersburg , 19825, Russian Federation
SRBHI "Regional Clinical Oncology Dispensary"
Velikiy Novgorod , 17302, Russian Federation
Institute For Oncology And Radiology Of Serbia
Belgrade , 11000, Serbia
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava , 812 5, Slovakia
Narodny Onkologicky ustav
Bratislava , 833 1, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Kosice , 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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

226

Study ID:

NCT02187744

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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