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    Summary
    EudraCT Number:2006-007018-39
    Sponsor's Protocol Code Number:Persephone
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2007-05-15
    Trial 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 number2006-007018-39
    A.3Full title of the trial
    Persephone : Duration of Trastuzumab with Chemotherapy in patients with early breast cancer : Six months versus twelve
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Persephone : Duration of Trastuzumab with Chemotherapy in patients with early breast cancer : Six months versus twelve
    A.3.2Name or abbreviated title of the trial where available
    Persephone
    A.4.1Sponsor's protocol code numberPersephone
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN52968807
    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 SponsorCambridge Hospitals NHS Foundation Trust and Cambridge University
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Health Technology Assessment Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Cambridge
    B.5.2Functional name of contact pointDr Helena Earl
    B.5.3 Address:
    B.5.3.1Street AddressAddenbrookes Hospital
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441223336800
    B.5.5Fax number441223763120
    B.5.6E-mailhme22@cam.ac.uk
    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.2.1.2Country 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 nameTrastuzumab
    D.3.4Pharmaceutical form Powder 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 INNrecombinant humanised monoclonal antibody
    D.3.9.1CAS number 180288-69-1
    D.3.9.3Other descriptive nameanti-HER2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number21mg/ml to 150 mg
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant humanised Monoclonal human antibody
    D.IMP: 2
    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 Herceptin (subcutaneous)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products 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 nameTrastuzumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrecombinant humanised monoclonal antibody
    D.3.9.1CAS number 180288-69-1
    D.3.9.3Other descriptive nameanti-HER2, Herceptin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120mg/ml
    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 Yes
    D.3.11.13.1Other medicinal product typeHerceptin recombinant humanised IgGI Monoclonal human antibody linked to an enzyme, the hyaluronidase EV substance code SUB12612MIG.
    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 early breast cancer
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: A phase III, randomised trial comparing 6 months trastuzumab treatment with 12 months, in patients with Her 2 positive early breast cancer, in terms of disease-free and overall survival.

    Primary endpoint
    Disease-free survival non-inferiority (equivalence) of 6 months trastuzumab to 12 months in early breast cancer.
    E.2.2Secondary objectives of the trial
    Secondary objectives (clinical)
    •Overall survival non-inferiority (equivalence) of 6 months trastuzumab to 12 months in early breast cancer.
    •Health Economic and quality of life superiority for 6 months trastuzumab versus 12 months.
    •Cardiac function as assessed by left ventricular ejection fraction (LVEF) 3 monthly during trastuzumab therapy, and analysis of predictive factors for development of cardiac damage.

    Secondary objectives (translational)
    •Assessment of tumour molecular profiling and candidate genes as prognostic and predictive markers of outcomes (disease-free and overall survival).
    •Assessment of patient genetic epidemiology and pharmacogenetics (single nucleotide polymorphism) as prognostic and predictive markers of outcomes (disease-free and overall survival, and toxicity of trastuzumab).


    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Research will also be conducted through the collection of tissue samples. Sub-studies are :
    • Trans - PERSEPHONE: Tumour blocks (paraffin-embedded) will be collected to discover molecular predictors of survival with respect to duration of trastuzumab treatment. Analysis of tumour tissue will involve (i) tissue microarrays for immunohistochemistry (IHC) of protein gene products and in situ hybridisation analysis, and (ii) whole-genome profiling using expression and DNA microarrays.

    • Trans - PERSEPHONE – SNPs: Blood samples will be used to discover single nucleotide polymorphisms (SNPs) as genetic / pharmacogenetic determinants of prognosis, toxicity and treatment outcome.
    E.3Principal inclusion criteria
    •Histological diagnosis of invasive breast cancer.
    •No evidence of metastatic disease.
    •Known hormone receptor status.
    •Overexpression of HER2 receptor.
    •Clear indication for neo-adjuvant or adjuvant chemotherapy based on clinical and histopathological features.
    •Patient fit to receive neo-adjuvant or adjuvant chemotherapy and trastuzumab in the opinion of the responsible physician.
    •No previous diagnosis of malignancy unless:
    -managed by surgical treatment only, and disease-free for 10 years.
    -previous basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast.
    •Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and agrees to adopt adequate contraceptive measures if pre-menopausal and sexually active.
    •No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up.
    •Women or men 18 years or older.
    •Written informed consent for the study given at any time before the 10th cycle of trastuzumab.
    E.4Principal exclusion criteria
    •Clinically significant cardiac disease including or significant co-morbidity in the opinion of the responsible physician adding to the risks associated with trastuzumab or cytotoxic chemotherapy.
    •Inability to comply with protocol requirements.
    •Patient having received more than 9 cycles of trastuzumab.
    •Any other condition, which in the local investigator’s opinion would make the patient unsuitable for participating in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point
    Disease-free survival non-inferiority (equivalence) of 6 months trastuzumab to 12 months in early breast cancer.

    Secondary end point
    •Overall survival non-inferiority (equivalence) of 6 months trastuzumab to 12 months in early breast cancer.
    •Health Economic Assessment (health resource use), toxicity and quality of life comparisons for 6 months and 12 months trastuzumab.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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
    Duration. Also, IMP tested in adjuvant and NEO-ADJUVANT setting (currently not licensed)
    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 concerned100
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 the trial
    The end of the intervention period of the trial will be 1 year after the last patient has been randomised into the trial (expected mid-2016).
    The non-interventional observation period of the trial will continue for at least 10 years following the administration of the last dose of the trastuzumab to the last patient or after the last biological material has been processed whichever comes later.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years14
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 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 state4000
    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)
    None
    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 Decision2007-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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