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    Summary
    EudraCT Number:2011-002132-10
    Sponsor's Protocol Code Number:MO27775
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-002132-10
    A.3Full title of the trial
    A randomized, two-arm, open-label, multicenter Phase II trial
    assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first line patients with HER2-positive and hormone receptor-positive advanced (metastatic or locally advanced) breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase II study comparing pertuzumab, trastuzumab and an aromatase inhibitor vs. trastuzumab and an aromatase inhibitor in patients with HER2 and ER/PgR positive breast cancer
    A.3.2Name or abbreviated title of the trial where available
    PERTAIN
    A.4.1Sponsor's protocol code numberMO27775
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Yes
    D.2.1.1.1Trade name Perjeta
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    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 namePertuzumab (rhuMAb 2C4)
    D.3.2Product code Ro 436-8451/F01
    D.3.4Pharmaceutical form 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 INNPertuzumab
    D.3.9.1CAS number 380610-27-5
    D.3.9.2Current sponsor codeRO4368451
    D.3.9.3Other descriptive namerhuMAb 2C4
    D.3.9.4EV Substance CodeSUB16455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number420 mg/14ml
    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- and hormone receptor-positive advanced (metastatic or locally advanced) breast cancer
    E.1.1.1Medical condition in easily understood language
    HER2- and hormone receptor-positive advanced 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 19.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 progression-free survival (PFS) of pertuzumab
    given in combination with trastuzumab plus an aromatase
    inhibitor (AI) versus trastuzumab plus an AI.
    E.2.2Secondary objectives of the trial
    To compare pertuzumab given in combination with trastuzumab
    plus an AI versus trastuzumab plus an AI with respect to:
    • Overall survival (OS)
    • Overall response rate (ORR)
    • Clinical benefit rate (CBR)
    • Duration of response
    • Time to response
    • Safety and tolerability
    • Quality of life (EQ-5D questionnaires)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent approved by the Institutional Ethical Review Board (IRB).
    2. Age greater than or equal to 18 years.
    3. Postmenopausal status (fulfilling one or more of
    National Comprehensive Cancer Network [NCCN] guideline
    criteria, Version 1.2016).
    4. Histologically or cytologically confirmed and documented
    adenocarcinoma of the breast with metastatic or locally
    advanced disease not amenable to curative resection.
    5. HER2-positive (defined as either IHC 3+ or ISH positive) as
    assessed by local laboratory on primary or metastatic tumor
    (ISH positivity is defined as a ratio of 2.0 or greater for the
    number of HER2 gene copies to the number of signals for
    CEP17, or for single probe tests, a HER2 gene count greater
    than 4).
    6. Hormone receptor-positive defined as ER-positive and/or
    PgR-positive assessed locally as defined by institutional criteria.
    7. At least one measurable lesion and/or non-measurable
    disease evaluable according to Response Evaluation Criteria
    In Solid Tumors (RECIST) version 1.1 (Eisenhauer et al. 2009).
    8. ECOG performance status 0 or 1.
    9. Left ventricular ejection fraction (LVEF) of at least 50%.
    10. Life expectancy of at least 12 weeks.
    E.4Principal exclusion criteria
    1. Previous systemic non-hormonal anticancer therapy in the
    metastatic or locally advanced breast cancer setting.
    2. Disease-free interval from completion of adjuvant or neo-adjuvant systemic non-hormonal treatment to recurrence
    of within 6 months.
    3. Previous approved or investigative anti-HER2 agents in any
    breast cancer treatment setting, except trastuzumab and/or
    lapatinib in the neoadjuvant or adjuvant setting.
    4. Disease progression while receiving trastuzumab and/or
    lapatinib in the adjuvant setting.
    5. History of persistent grade 2 or higher (NCI-CTC, Version
    4.0) hematological toxicity resulting from previous adjuvant
    or neo-adjuvant therapy.
    6. Patients with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy (eg dexamethasone)). Note: Patients with CNS metastases are permitted to participate in the study if they are medically well controlled prior to screening (as assessed by the investigator) after receiving local therapy (irradiation, surgery etc) but without anti-HER2 therapy.
    7. Current peripheral neuropathy of grade 3 or higher (NCI-CTC, Version 4.0).
    8. History of other malignancy within the last 5 years, except
    for carcinoma in situ of the cervix or basal cell carcinoma.
    9. Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or that would put the patient at high risk for reatment related complications.
    10. Inadequate organ function, evidenced by the following
    laboratory results:
    • Absolute neutrophil count <1,500 cells/mm3.
    • Platelet count <100,000 cells/mm3.
    • Hemoglobin <9 g/dL.
    • Total bilirubin greater than the upper limit of normal (ULN) unless the patient has documented Gilbert’s syndrome).
    • AST (SGOT) or ALT (SGPT) >2.5 × ULN.
    • AST (SGOT) or ALT (SGPT) >1.5 × ULN with concurrent serum alkaline phosphatase >2.5 × ULN Serum alkaline phosphatase may be >2.5 × ULN only if bone metastases are present and AST
    (SGOT) and ALT (SGPT) <1.5 × ULN.
    • Serum creatinine >2.0 mg/dL or 177 μmol/L.
    • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 × ULN (unless on therapeutic coagulation).
    11. Uncontrolled hypertension (systolic >150 mm Hg and/or
    diastolic >100 mm Hg) or clinically significant (i.e. active)
    cardiovascular disease: cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study edication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication.
    12. Current known infection with HIV, HBV, or HCV.
    13. Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen
    therapy.
    14. Major surgical procedure or significant traumatic injury
    within 14 days prior to randomization or anticipation of need
    for major surgery during the course of study treatment. Note: Should surgery be necessary during the course of the study, patients should be allowed to recover for a minimum of 14 days prior to subsequent pertuzumab and trastuzumab treatment.
    15. Lack of physical integrity of the upper gastrointestinal tract,
    clinically significant malabsorption syndrome, or inability to
    take oral medication.
    16. Receipt of intravenous antibiotics for infection within 7 days prior to randomization.
    17. Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose of 10 mg/day methylprednisolone equivalent), excluding inhaled steroids.
    18. Known hypersensitivity to any of the study medications or to
    excipients of recombinant human or humanized antibodies.
    19. History of receiving any investigational treatment within 28
    days prior to randomization.
    20. Concurrent participation in any other therapeutic clinical trial.
    21. Assessed by the investigator to be unable or unwilling to
    comply with the requirements of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is Progression-Free Survival (PFS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis of PFS will be performed when 165 events have occurred.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    - OS
    - ORR
    - CBR
    - Duration of response
    - Time to response
    E.5.2.1Timepoint(s) of evaluation of this end point
    A first analysis of OS will be performed with the final analysis of PFS. The final analysis of OS will take place once all patients have been followed up for at least 60 months after the last patient is randomized, unless they have been lost to follow-up, withdrawn consent, or died, whichever occurs first. All other secondary endpoints will be summarized with the final analysis of PFS.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life, Tolerability
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pertuzumab + Herceptin + AI versus Herceptin + AI
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Brazil
    European Union
    India
    Turkey
    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
    The study will end when all patients have been followed up for at least 60 months after the last patient is randomized unless they have been lost to follow up, withdrawn consent, or died, or if the study is prematurely terminated by the Sponsor, whichever occurs first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 250
    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)
    Patients who discontinue study treatment for progressive disease or other reasons will receive treatment according to the local standard of care.

    Provision of pertuzumab for patients still benefitting of Perjeta might continue to be treated as part of an extension study for the purpose of collecting safety data and pre-specified efficacy measures.
    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 Decision2011-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-14
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