A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
Completed · Phase 3
Conditions studied: Early Breast Cancer
In brief
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%.
Key facts
- Study ID
- NCT02187744
- Run by
- Pfizer
- People needed
- 226
- Starts
- 2014-09-23
- Expected to finish
- 2016-03-09
- Last updated by the study team
- 2019-01-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
- Compassionate Cancer Care Medical Group, Inc. — Fountain Valley, California, United States
Full record on ClinicalTrials.gov
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