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%.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 50 Locations for this study
Fountain Valley California, 92708, United States
Kingwood Texas, 77339, United States
Shenandoah Texas, 77380, United States
Shenandoah Texas, 77384, United States
Lesnoy Minsk Region, 22304, Belarus
Hradec Kralove , 500 0, Czechia
Kecskemet Bacs-kiskun, 6000, Hungary
Budapest , 1083, Hungary
Budapest , 1115, Hungary
Budapest , 1145, Hungary
Miskolc , 3526, Hungary
Szolnok , 5000, Hungary
Milano MI, 20141, Italy
Roma RM, 00144, Italy
Roma RM, 00144, Italy
Roma RM, 00168, Italy
Gdynia , 81-51, Poland
Lodz , 93-51, Poland
Olsztyn , 10-22, Poland
Kuzmolovo Leningrad Region, 18866, Russian Federation
Ufa Republic Bashkortost, 45005, Russian Federation
Kislino Settlement Ryshkovskiy Village Council, 30552, Russian Federation
Pyatigorsk Stavropol Region, 35750, Russian Federation
Volzhskiy Volgograd Region, 40413, Russian Federation
Irkutsk , 66403, Russian Federation
Kursk , 30503, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12930, Russian Federation
Nizhniy Novgorod , 60300, Russian Federation
Nizhniy Novgorod , 60308, Russian Federation
Omsk , 64404, Russian Federation
Saint-Petersburg , 19506, Russian Federation
Saint-Petersburg , 19624, Russian Federation
Saint-Petersburg , 19624, Russian Federation
Saint-Petersburg , 19704, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Saint-Petersburg , 19825, Russian Federation
Velikiy Novgorod , 17302, Russian Federation
Belgrade , 11000, Serbia
Bratislava , 812 5, Slovakia
Bratislava , 833 1, Slovakia
Kosice , 04191, Slovakia
Chernihiv , 14029, Ukraine
Dnipropetrovsk , 49102, Ukraine
Kharkiv , 61024, Ukraine
Kharkiv , 61070, Ukraine
Khmelnytskyi , 29009, Ukraine
Kryvyi Rih , 50048, Ukraine
Lviv , 79031, Ukraine
Odesa , 65025, Ukraine
Sumy , 40005, Ukraine
Vinnytsia , 21029, Ukraine
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.