A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
- Conditions
- Early Breast Cancer
- Interventions
- Registration Number
- NCT02187744
- Lead Sponsor
- Pfizer
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 226
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-05280014 PF-05280014 - Herceptin® Trastuzumab-EU - PF-05280014 Taxotere® - Herceptin® Taxotere® - PF-05280014 Paraplatin® - Herceptin® Paraplatin® -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5. Cycle 5 The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) \>20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.
- Secondary Outcome Measures
Name Time Method Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6. Cycles 1 through 6 Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.
Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes. Cycle 6/End of treatment Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.
Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor. Cycle 6/End of treatment ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.
Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6. Cycles 1 through 6 The number of participants with positive (titer \>=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.
Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6. Cycles 1 through 6 The number of participants with positive (NAb response \>=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.
Trial Locations
- Locations (51)
Saint-Peterbsurg Clinical Oncological dispensary of Moscow district
🇷🇺Saint-Petersburg, Russian Federation
LLC RAMSAY Diagnostic RUS
🇷🇺Saint-Petersburg, Russian Federation
Institute For Oncology And Radiology Of Serbia
🇷🇸Belgrade, Serbia
Narodny Onkologicky ustav
🇸🇰Bratislava, Slovakia
Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
🇺🇦Sumy, Ukraine
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet
🇭🇺Szolnok, Hungary
State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary"
🇷🇺Nizhniy Novgorod, Russian Federation
Uzsoki Utcai Korhaz, Onkoradiologia, Sugarterapia Fovarosi Onkoradiologiai Kozpont
🇭🇺Budapest, Hungary
SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
🇵🇱Olsztyn, Poland
Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary"
🇷🇺Omsk, Russian Federation
Onkologicky ustav sv. Alzbety, s.r.o.
🇸🇰Bratislava, Slovakia
State Budgetary Educational Institution of Higher Professional Education "North-Western State
🇷🇺Saint-Petersburg, Russian Federation
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz. Belgyogyaszati Klinika Onkologiai Reszleg
🇭🇺Budapest, Hungary
FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS
🇷🇺Moscow, Russian Federation
MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;
🇺🇦Dnipropetrovsk, Ukraine
MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
🇺🇦Kryvyi Rih, Ukraine
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Millennium Oncology (Imaging Facility)
🇺🇸Shenandoah, Texas, United States
Szpitale Wojewodzkie w Gdyni Sp. z o.o., Oddzial Onkoligii i Radioterapii
🇵🇱Gdynia, Poland
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktatokorhaz,
🇭🇺Miskolc, Hungary
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
Oddzial Chorob Rozrostowych
🇵🇱Lodz, Poland
Bacs-Kiskun Megyei Korhaz
🇭🇺Kecskemet, Bacs-kiskun, Hungary
Szent Imre Egyetemi Oktato Korhaz
🇭🇺Budapest, 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
"State Budgetary Healthcare Institution ""Republican Clinical Oncological Dispensary of the Ministry
🇷🇺Ufa, Republic Bashkortost, Russian Federation
"State Budgetary Healthcare Institution of Stavropol Region ""Pyatigorsk Oncological Dispensary"""
🇷🇺Pyatigorsk, Stavropol Region, Russian Federation
Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary"
🇷🇺Kislino Settlement, Ryshkovskiy Village Council, Russian Federation
SBHI of NNR "Clinical diagnostic center"
🇷🇺Nizhniy Novgorod, Russian Federation
SRBHI "Regional Clinical Oncology Dispensary"
🇷🇺Velikiy Novgorod, Russian Federation
State Budgetary Healthcare Institution "Volgograd Regional Oncological Dispensary #3"
🇷🇺Volzhskiy, Volgograd Region, Russian Federation
SBHI "Regional Oncology Dispensary"
🇷🇺Irkutsk, Russian Federation
State Budgetary Institution Of Healthcare
🇷🇺Moscow, Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"
🇷🇺Saint-Petersburg, Russian Federation
SI "Institute of Medical Radiology n.a.S.P. Hrygoriev of National Academy
🇺🇦Kharkiv, Ukraine
Regional Budgetary Healthcare Institution
🇷🇺Kursk, Russian Federation
"Federal State Institution ""Scientific Research Institute of Oncology n.a. N.N.Petrov""
🇷🇺Saint-Petersburg, Russian Federation
Vychodoslovensky onkologicky ustav, a.s.
🇸🇰Kosice, Slovakia
Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary"
🇷🇺Saint-Petersburg, Russian Federation
Municipal Healthcare Institution 'Chernihiv Regional Oncology Dispensary', Mamology Department
🇺🇦Chernihiv, Ukraine
Khmelnytskyi Regional Oncologic Dispensary
🇺🇦Khmelnytskyi, Ukraine
Vinnytsia Regional Oncology Clinical Dispensary, Chemotherapy Department
🇺🇦Vinnytsia, Ukraine
Compassionate Cancer Care Medical Group, Inc.
🇺🇸Fountain Valley, California, United States
State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"
🇷🇺Kuzmolovo, Leningrad Region, Russian Federation
Munincipal Healthcare Institution"Kharkiv Regional Clinical Oncologic Center
🇺🇦Kharkiv, Ukraine
Municipal Institution 'Odesa Regional Clinical Hospital', Mamology Center
🇺🇦Odesa, Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Center
🇺🇦Lviv, Ukraine