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

December 19, 2018 updated by: Pfizer

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

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
    • Minsk Region
      • Lesnoy, Minsk Region, Belarus, 223040
        • SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Hungary
      • Budapest, Hungary, 1115
        • Szent Imre Egyetemi Oktato Korhaz
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz. Belgyogyaszati Klinika Onkologiai Reszleg
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Korhaz, Onkoradiologia, Sugarterapia Fovarosi Onkoradiologiai Kozpont
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktatokorhaz,
      • Szolnok, Hungary, 5000
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet
    • Bacs-kiskun
      • Kecskemet, Bacs-kiskun, Hungary, 6000
        • Bács-Kiskun Megyei Kórház
  • Italy
    • MI
      • Milano, MI, Italy, 20141
        • Division of Medical Senology
    • RM
      • Roma, RM, Italy, 00144
        • Divisione di Oncologia Medica B
      • Roma, RM, Italy, 00144
        • IRCCS Istituto Nazionale Tumori Regina Elena (IRE)
      • Roma, RM, Italy, 00168
        • Dept. of Surgery
  • Poland
      • Gdynia, Poland, 81-519
        • Szpitale Wojewodzkie w Gdyni Sp. z o.o., Oddzial Onkoligii i Radioterapii
      • Lodz, Poland, 93-513
        • Oddzial Chorob Rozrostowych
      • Olsztyn, Poland, 10-228
        • SPZOZ MSW z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Russian Federation
      • Irkutsk, Russian Federation, 664035
        • SBHI "Regional Oncology Dispensary"
      • Kursk, Russian Federation, 305035
        • Regional Budgetary Healthcare Institution
      • Moscow, Russian Federation, 115478
        • FSBI "Russian Oncology Scientific center n.a. N. N. Blokhin" RAMS
      • Moscow, Russian Federation, 129301
        • State Budgetary Institution Of Healthcare
      • Nizhniy Novgorod, Russian Federation, 603006
        • SBHI of NNR "Clinical diagnostic center"
      • Nizhniy Novgorod, Russian Federation, 603081
        • State Budgetary Healthcare Institution of NNR "Nizhniy Novgorod Regional Oncological Dispensary"
      • Omsk, Russian Federation, 644046
        • Budgetary Institution of healthcare of Omsk region "Clinical oncological dispensary"
      • Saint-Petersburg, Russian Federation, 195067
        • State Budgetary Educational Institution of Higher Professional Education "North-Western State
      • Saint-Petersburg, Russian Federation, 196247
        • Saint-Peterbsurg Clinical Oncological dispensary of Moscow district
      • Saint-Petersburg, Russian Federation, 196247
        • Saint-Petersburg State Budgetary Healthcare Institution "Oncological Dispensary of Moscow District"
      • Saint-Petersburg, Russian Federation, 197046
        • LLC RAMSAY Diagnostic RUS
      • Saint-Petersburg, Russian Federation, 197758
        • "Federal State Institution ""Scientific Research Institute of Oncology n.a. N.N.Petrov""
      • Saint-Petersburg, Russian Federation, 198255
        • Saint-Petersburg State Budgetary Institution of healthcare "City Clinical Oncological Dispensary"
      • Velikiy Novgorod, Russian Federation, 173023
        • SRBHI "Regional Clinical Oncology Dispensary"
    • Leningrad Region
      • Kuzmolovo, Leningrad Region, Russian Federation, 188663
        • State Budgetary Healthcare Institution "Leningrad Regional Oncological Dispensary"
    • Republic Bashkortost
      • Ufa, Republic Bashkortost, Russian Federation, 450054
        • "State Budgetary Healthcare Institution ""Republican Clinical Oncological Dispensary of the Ministry
    • Ryshkovskiy Village Council
      • Kislino Settlement, Ryshkovskiy Village Council, Russian Federation, 305524
        • Regional Budgetary Healthcare Institution "Kursk regional clinical oncological Dispensary"
    • Stavropol Region
      • Pyatigorsk, Stavropol Region, Russian Federation, 357502
        • "State Budgetary Healthcare Institution of Stavropol Region ""Pyatigorsk Oncological Dispensary"""
    • Volgograd Region
      • Volzhskiy, Volgograd Region, Russian Federation, 404130
        • State Budgetary Healthcare Institution "Volgograd Regional Oncological Dispensary #3"
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Narodny onkologicky ustav
      • Bratislava, Slovakia, 812 50
        • Onkologicky ustav sv. Alzbety, s.r.o.
      • Kosice, Slovakia, 04191
        • Vychodoslovensky onkologicky ustav, a.s.
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • Municipal Healthcare Institution 'Chernihiv Regional Oncology Dispensary', Mamology Department
      • Dnipropetrovsk, Ukraine, 49102
        • MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;
      • Kharkiv, Ukraine, 61024
        • SI "Institute of Medical Radiology n.a.S.P. Hrygoriev of National Academy
      • Kharkiv, Ukraine, 61070
        • Munincipal Healthcare Institution"Kharkiv Regional Clinical Oncologic Center
      • Khmelnytskyi, Ukraine, 29009
        • Khmelnytskyi Regional Oncologic Dispensary
      • Kryvyi Rih, Ukraine, 50048
        • MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'
      • Lviv, Ukraine, 79031
        • Lviv State Oncologic Regional Treatment and Diagnostic Center
      • Odesa, Ukraine, 65025
        • Municipal Institution 'Odesa Regional Clinical Hospital', Mamology Center
      • Sumy, Ukraine, 40005
        • Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
      • Vinnytsia, Ukraine, 21029
        • Vinnytsia Regional Oncology Clinical Dispensary, Chemotherapy Department
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Medical Group, Inc.
    • Texas
      • Kingwood, Texas, United States, 77339
        • Millennium Oncology (Imaging Facility)
      • Shenandoah, Texas, United States, 77384
        • Millennium Oncology
      • Shenandoah, Texas, United States, 77380
        • Millennium Oncology (Imaging Facility)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PF-05280014
Biological: PF-05280014
Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles.
Drug: Taxotere®
Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Other Names:
  • docetaxel
Drug: Paraplatin®
Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Other Names:
  • carboplatin
Active Comparator: Herceptin®
Drug: Taxotere®
Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Other Names:
  • docetaxel
Drug: Paraplatin®
Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
Other Names:
  • carboplatin
Biological: Trastuzumab-EU
Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.
Time Frame: 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.
Cycle 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.
Time Frame: 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.
Cycles 1 through 6
Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.
Time Frame: Cycle 6/End of treatment
Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.
Cycle 6/End of treatment
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.
Time Frame: 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.
Cycle 6/End of treatment
Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.
Time Frame: 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.
Cycles 1 through 6
Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.
Time Frame: 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.
Cycles 1 through 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B3271004
  • REFLECTIONS B327-04
  • 2013-004679-11 (EudraCT Number)
  • REFLECTIONS (B327-04) (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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