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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Early Breast Cancer

Intervention: PF-05280014 (Biological); Taxotere® (Drug); Paraplatin® (Drug); Trastuzumab-EU (Biological); Taxotere® (Drug); Paraplatin® (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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%.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of patients with steady state drug concentration Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL between trastuzumab-Pfizer versus Herceptin®

Secondary outcome:

Pathologic Complete Response (pCR) defined as the absence of invasive neoplastic cells in the breast and lymph nodes.

Incidence of anti-trastuzumab antibodies (ADAs), including neutralizing antibodies (NAb).

Trough trastuzumab-Pfizer and Herceptin® (trastuzumab-EU) concentrations at selected cycles.

Objective Response Rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Healthcare Institution "Brest Regional Oncologic Dispensary", Brest 224027, Belarus; Not yet recruiting

Fakultni Nemocnice Hradec Kralove, Hradec Kralove 500 05, Czech Republic; Recruiting

Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz. Belgyogyaszati Klinika Onkologiai Reszleg, Budapest 1083, Hungary; Recruiting

Szent Imre Egyetemi Oktatokorhaz, Budapest 1115, Hungary; Recruiting

Uzsoki Utcai Korhaz, Onkoradiologia, Sugarterapia Fovarosi Onkoradiologiai Kozpont, Budapest 1145, Hungary; Recruiting

Bacs-Kiskun Megyci Korhaz, Onkoradiologiai Kozpont, Kecskemet 6000, Hungary; Recruiting

Borsod-Abauj-Zemplen M-i Korhaz, es Egyetemi Oktatokorhaz, Klinikai Onkologiai es Sugarterapias, Miskolc 3526, Hungary; Recruiting

Jasz- Nagykun- Szolnok Megyei Hetenyi Geza Korhaz- Rendelointezet,, Szolnok 5000, Hungary; Recruiting

Szpital Morski im. PCK Sp. z o.o., Gdynia 81-519, Poland; Recruiting

Oddzial Onkologiczny Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej, Jelenia Gora 58-506, Poland; Not yet recruiting

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi-Oddzial Chorob Rozrostowych, Lodz 93-513, Poland; Recruiting

SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Oddzial Kliniczny Chemioterapii, Olsztyn 10-228, Poland; Recruiting

SBHI "Regional Oncology Dispensary", Irkutsk 664035, Russian Federation; Recruiting

FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS, Moscow 115478, Russian Federation; Recruiting

GBUZ"City clinical hospital #40 of healthcare department of Moscow city", Moscow 129301, Russian Federation; Recruiting

SBHI of NNR "Clinical diagnostic center", Nizhniy Novgorod 603006, Russian Federation; Recruiting

State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary", Nizhniy Novgorod 603081, Russian Federation; Recruiting

Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary", Omsk 644046, Russian Federation; Recruiting

Saint-Petersburg State Institution Of Healthcare "City Clinical Oncology Dispensary", Saint-Peterburg 197022, Russian Federation; Recruiting

Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District", Saint-Petersburg 196247, Russian Federation; Recruiting

Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary", Saint-Petersburg 198255, Russian Federation; Recruiting

State Budgetary Educational Institution of Higher Professional Education "North-Western State, Saint-Petersburg 195067, Russian Federation; Recruiting

State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Dispensary", Velikiy Novgorod 173016, Russian Federation; Recruiting

State Budgetary Institution of Healthcare "Volgograd Regional Oncological Dispensary #3", Volzhsky 404133, Russian Federation; Recruiting

CHC "Bezanijska kosa", Belgrade 11080, Serbia; Not yet recruiting

Institute For Oncology And Radiology Of Serbia, Belgrade 11000, Serbia; Recruiting

Poliklinika ST Medicina, Novi Sad 21000, Serbia; Not yet recruiting

Oncology Institute of Vojvodina, Sremska kamenica 21204, Serbia; Not yet recruiting

Mammacentrum sv. Agaty ProCare, a.s, Banska Bystrica 974 01, Slovakia; Recruiting

Narodny Onkologicky ustav, Bratislava 833 10, Slovakia; Recruiting

Onkologicky ustav sv. Alzbety, s.r.o., Bratislava 812 50, Slovakia; Recruiting

Vychodoslovensky onkologicky ustav a.s., Kosice 041 91, Slovakia; Recruiting

Municipal Healthcare Institution 'Chernihiv Regional Oncology Dispensary', Mamology Department, Chernihiv 14029, Ukraine; Recruiting

Municipal Institution "Chernivtsi Regional Clinical Oncology Center", Day Care Inpatient Department, Chernivtsi 58013, Ukraine; Not yet recruiting

MI 'City Dnipropetrovsk Multi-field Clinical Hospital #4 of DRC', Department of Chemotherapy; SI, Dnipropetrovsk 49102, Ukraine; Recruiting

Institute of Medical Radiology, Kharkiv 61024, Ukraine; Recruiting

Munincipal Healthcare Institution 'Kharkiv Regional Clinical Oncologic Center', Kharkiv 61070, Ukraine; Recruiting

Munincipal Healthcare Institution"Kharkiv Regional Clinical Oncologic, Kharkiv 61070, Ukraine; Recruiting

Khmelnytskyi Regional Oncologic Dispensary, Khmelnytskyi 29009, Ukraine; Recruiting

MI 'Kryvyi Rih Oncology Dispensary of Dipropetrovsk Regional Council', Chemotherapy Department, Kryvyi Rih 50048, Ukraine; Recruiting

Lviv State Oncologic Regional Treatment and Diagnostic Center, Lviv 79031, Ukraine; Recruiting

Municipal Institution 'Odesa Regional Clinical Hospital', Mamology Center, Odesa 65025, Ukraine; Recruiting

Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department, Sumy 40005, Ukraine; Recruiting

Vinnytsia Regional Oncology Clinical Dispensary, Vinnytsia 21029, Ukraine; Active, not recruiting

UOC Oncologia, Bologna, BO 40139, Italy; Not yet recruiting

Compassionate Care Research Group, Inc., Fountain Valley, California 92708, United States; Recruiting

State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary", Kuzmolovo, Leningrad Region 188663, Russian Federation; Recruiting

Division of Medical Senology, Milano, MI 20141, Italy; Recruiting

Greater Washington Oncology Associates, Riverdale, Maryland 20737, United States; Not yet recruiting

Greater Washington Oncology Associates, Silver Spring, Maryland 20910, United States; Not yet recruiting

Holy Cross Hospital, Silver Spring, Maryland 20910, United States; Not yet recruiting

Holy Cross Hospital Hospital Pharmacy (IP Shipment Address), Silver Spring, Maryland 20910, United States; Not yet recruiting

Holy Cross Hospital Resource Center, Silver Spring, Maryland 20902, United States; Not yet recruiting

Maryland Oncology Hematology, P.A., Wheaton, Maryland 20902, United States; Not yet recruiting

SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov', Lesnoy, Minsk Region 223040, Belarus; Not yet recruiting

Casa di Cura "La Maddalena" - Oncologia Medica, Palermo, PA 90146, Italy; Not yet recruiting

FSBI "Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint-Petersburg, Poselok Pesochny 197758, Russian Federation; Recruiting

Dept. of Surgery, Roma, RM 00168, Italy; Recruiting

Divisione di Oncologia Medica B - IRCCS Istituto Nazionale Tumori Regina Elena (IRE), Rome, RM 00144, Italy; Recruiting

"Republican Clinical Oncological Dispensary of the Ministry of Healthcare, Ufa, Republic of Bashkortostan 450054, Russian Federation; Recruiting

Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary", Kislino settlement, Ryshkovskiy village council 305524, Russian Federation; Recruiting

State Budgetary Institution ofhealthcare of Stavropol region "Pyatigorsk oncology dispensary", Pyatigorsk, Stavropol region 357502, Russian Federation; Recruiting

Meharry Medical College, Nashville, Tennessee 37208, United States; Not yet recruiting

Nashville General Hospital, Nashville, Tennessee 37208, United States; Not yet recruiting

Millennium Oncology (IP Shipment Address), Houston, Texas 77090, United States; Recruiting

Millennium Oncology (Imaging Facility), Kingwood, Texas 77339, United States; Recruiting

Millennium Oncology, Shenandoah, Texas 77384, United States; Recruiting

Millennium Oncology (Imaging Facility), Shenandoah, Texas 77380, United States; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2014
Last updated: August 17, 2015

Page last updated: August 23, 2015

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