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    Summary
    EudraCT Number:2013-004679-11
    Sponsor's Protocol Code Number:B3271004
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-004679-11
    A.3Full title of the trial
    A Randomized, Double-blind Pharmacokinetic Study of PF-05280014 Plus Taxotere and Carboplatin Versus Herceptin Plus Taxotere And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable HER2-Positive Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial for patients with breast cancer
    A.3.2Name or abbreviated title of the trial where available
    REFLECTIONS B327-04
    A.4.1Sponsor's protocol code numberB3271004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02187744
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc, 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E. 42nd Street
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.GovCallCentre@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTrastuzumab-Pfizer
    D.3.2Product code PF-05280014
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Herceptin®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Reg. Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHerceptin®
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codetrastuzumab-EI
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HER2-Positive Breast Cancer (Early Stage)
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10006194
    E.1.2Term Breast cancer NOS stage I
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the percentage of patients with steady state (Cycle 5) Ctrough >20 μg/mL between trastuzumab-Pfizer versus Herceptin® in patients with operable HER2-positive breast cancer who receive therapy together with Taxotere® and carboplatin in the neoadjuvant setting.
    E.2.2Secondary objectives of the trial
    •To evaluate measures of tumor control for trastuzumab-Pfizer versus Herceptin®, when administered with combination with Taxotere® and carboplatin in the neoadjuvant setting;
    •To evaluate the safety of trastuzumab-Pfizer versus Herceptin®, administered in combination with Taxotere® and carboplatin;
    •To evaluate the immunogenicity of trastuzumab-Pfizer versus Herceptin®;
    •To evaluate the Pharmacokinetics (PK) of trastuzumab-Pfizer and Herceptin®;
    •To explore the relationship between drug exposure and pathologic complete response (pCR) for trastuzumab-Pfizer versus Herceptin®, administered in combination with Taxotere® and carboplatin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients aged 18 years or older.
    2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study.
    3. Histologically confirmed HER2 overexpressing invasive breast cancer.
    4. Plan for definitive surgical resection of breast tumor (ie, lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
    5. Plan for neoadjuvant chemotherapy.
    6. Documentation of HER2 gene amplification or overexpression by one of the following:
    •Gene amplification by fluorescent in-situ hybridization (FISH) chromogenic in-situ hybridization (CISH); or dual in-situ hybridization (DISH) (as defined by the manufacturer's kit instruction); OR
    •Overexpression by immunohistochemistry (IHC) categorized as IHC3+; OR
    •Overexpression by immunohistochemistry categorized as IHC2+ with FISH, CISH, or DISH confirmation.
    Determination of HER2 positive status using one of the Sponsor approved analytical test methods listed in the Case Record Form
    If HER2 status is unavailable or was determined using a test other than a Sponsor-approved assay listed in Appendix 1 of the Protocol, eligibility must be documented prior to randomization: a. Confirmed by the
    Sponsor-provided central laboratory;b. HER2 local testing using both an IHC and an in-situ hybridization analytical test neither of which are considered Sponsor approved. The results from both assays must be unequivocal (ie, IHC result must be categorized as IHC3+).
    7. Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm.
    8. Known Estrogen Receptor (ER) and Progesterone Receptor (PR) hormone status at study entry.
    9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    10. Left ventricular ejection fraction (LVEF) of ≥ 55% by 2D echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA).
    11. Normal bone marrow function as defined by:
    •absolute neutrophil count (ANC) > 1.5 x 109 g/dL (1,500/μL);
    •platelets > 100 x 109 g/dL (100,000/μL);
    •hemoglobin > 10.0 g/dL.
    12. Normal hepatic function as defined by:
    •total bilirubin ≤ 1.5 x upper limit of normal (ULN) (<3 ULN if Gilberts disease);
    •aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (≤ 5x ULN if liver metastases are present).
    13. Patients with an elevated unconjugated bilirubin (Gilbert's syndrome) will be eligible if hepatic enzymes and function are otherwise within normal limits (ie, AST, ALT, and Alkaline Phosphatase are within normal limits), and there is no evidence of hemolysis.
    14. Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance (CrCl) ≥ 50 mL/min calculated by the Cockcroft-Gault.
    15. Patients of childbearing potential must agree to use a highly effective methods of contraception as described in Section 4.4 Life Style Guidelines of the Protocol, throughout the study and for 12 months after
    the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
    16. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
    2. Bilateral breast cancer.
    3. Inflammatory breast cancer.
    4. Presence of known distant metastases (determined by principal investigator).
    5. Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.
    6. Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
    7. Pre-existing clinically significant (≥ grade 2) peripheral neuropathy.
    8. Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension.
    9. Severe dyspnea at rest requiring supplementary oxygen therapy.
    10. Known or demonstrated viral infection as listed below. Testing to demonstrate eligibility is required only in countries where regulations mandate testing. In all other countries, testing should be considered if a patient is at risk for having undiagnosed infection (for
    example due to history of injection drug use or due to geographic location).
    a.Seropositivity for human immunodeficiency virus (HIV);
    b. Hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to hepatitis C virus [anti HCV] with confirmatory testing).
    11. Recent infection requiring a course of systemic anti-infectives that were completed ≤ 14 days before enrollment (with the exception of uncomplicated urinary tract infection).
    12. Participation in other studies involving investigational drug(s) (Phases 1-4) within ≥ 4 weeks before randomization and/or during study participation. Patients participating in observational studies not involving an investigational drug(s) and/or long-term follow up of studies involving an investigational drug(s) in which treatment was completed 4 weeks before randomization are not excluded.
    13. History of severe hypersensitivity reaction to platinum-coordination compounds, taxanes, trastuzumab, murine proteins, or excipients in their formulations.
    14. Clinical contraindication to treatment with steroids preventing use as part of Taxotere® premedication.
    15. Pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for 12 months after last dose of investigational product.
    16. History of another cancer diagnosis (including contralateral breast cancer) within 5 years prior to screening for this study, with the exception of adequately treated ductal carcinoma in situ, cervical carcinoma in situ, or basal or squamous cell skin cancer.
    17. Other severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    18. Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Percent of patients with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 6 pre-dose - day 105
    E.5.2Secondary end point(s)
    - Pathologic Complete Response (pCR) defined as the absence of invasive neoplastic cells in the breast and lymph nodes.
    - Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study therapy of adverse events and laboratory abnormalities.
    - Incidence of anti-trastuzumab antibodies (ADA), including neutralizing antibodies (NAb).
    - Trough trastuzumab-Pfizer and Herceptin® (trastuzumab-EU) concentrations at selected cycles.
    - Objective Response Rate (ORR) defined as the percentage of subjects having Complete or Partial Response at EOT, based on radiographic assessments of the tumor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See study flow chart pgs. 8-10 of the protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Herceptin
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Czech Republic
    Hungary
    Italy
    Poland
    Russian Federation
    Serbia
    Slovakia
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient patients have been recruited and completed the study as stated in the Regulatory application.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 88
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    This is a research study. The study drug, PF-05280014, and comparator trastuzumab, as well as the study defined medical care will only be given to the subjects during the study.
    As stated in the protocol, for adverse events (serious/non-serious) with a causal relationship to the study drug, follow-up by the investigator is required until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-09
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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