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    Summary
    EudraCT Number:2015-003106-16
    Sponsor's Protocol Code Number:B2
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-003106-16
    A.3Full title of the trial
    Immunogenicity of influenza vaccination among breast cancer patients
    treated with trastuzumab in adjuvant setting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of infuenza vaccination in patients with breast cancer treated
    with trastuzumab postoperatively
    A.4.1Sponsor's protocol code numberB2
    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 SponsorAntonis Valachis
    B.1.3.4CountrySweden
    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 supportLandstinget Sörmland
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportLandstinget Västmanland
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportÖrebro Läns Landsting
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntonis Valachis
    B.5.2Functional name of contact pointAntonis Valachis
    B.5.3 Address:
    B.5.3.1Street Address63188 Mälarsjukhuset
    B.5.3.2Town/ cityEskilstuna
    B.5.3.3Post code63188
    B.5.3.4CountrySweden
    B.5.6E-mailantonis.valachis@igp.uu.se
    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 Trastuzumab
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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 Fluarix
    D.2.1.1.2Name of the Marketing Authorisation holderPL 10592/0302
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFluarix
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    Efficacy of vaccination against influenza in patients with breast cancer
    treated with Trastuzumab as adjuvant therapy
    E.1.1.1Medical condition in easily understood language
    Efficacy of vaccination against influenza in patients with breast cancer
    treated with Trastuzumab as treatment after surgery
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To investigate the immunogenicity of influenza vaccination in breast
    cancer patients treated with trastuzumab in adjuvant setting
    E.2.2Secondary objectives of the trial
    Secondary aim is to investigate the tolerability of influenza vaccination
    to this group of breast cancer patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with stage I-II or operable stage III HER2 – positive (FISH or CISH with amplification and / or +++ in immunohistochemistry) breast cancer, after breast cancer surgery (breast-conserving surgery or mastectomy), without any clinical or radiological signs of distant metastasis (radiologic work-up is not necessary; according to local guidelines).
    2. Woman > 18 years of age.
    3. Radiotherapy (local or locoregional) prior or during the study inclusion period is allowed.
    4. Endocrine therapy (tamoxifen or aromatase inhibitors) is allowed.
    5. Prior neoadjuvant or adjuvant chemotherapy is allowed only if the time period between the last cycle of chemotherapy and inclusion to the study is at least 1 month.
    6. Both intravenous and subcutaneous formulations of trastuzumab are allowed.
    7. Able to read, understand, and sign informed consent.
    E.4Principal exclusion criteria
    1. Inflammatory breast cancer or inoperable stage III breast cancer.
    2. Presence of distant metastases.
    3. Possible change of anti-cancer treatment before the first evaluation of immunogenicity following the first injection (to avoid bias related to any therapy changes).
    4. History of another malignancy within the last 5 years except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
    5. Neutrophils < 1.5 x 109/L
    6. Left ventricular ejection fraction (LVEF) less than 50% (or under the institutional normal reference range) assessed by echocardiography or isotope cardiography.
    7. Fever at time of vaccination (temperature of ≥ 38.5 C).
    8. Known allergic reaction to any of the components of the vaccine (e.g. hypersensitivity to egg protein).
    9. Treatment with cortison (> 15 mg prednisolone or equivalent daily) or any other immunosuppressive agent at the moment of vaccination.
    10. Any other immunosuppressive disease (such as HIV infection, renal insufficiency, cirrhosis).
    11. History of clinically or virologically confirmed influenza infection in the previous 6 months.
    12. Any other immunization carried out in the 3 weeks before the first injection or planned in the following month.
    13. Pregnant or lactating women. Positive serum pregnancy test in women of childbearing potential within seven days prior to the first dose of study drug.
    14. Women of childbearing potential unless using a reliable and appropriate contraceptive method (hormonal methods: combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices; non-hormonal methods: intrauterine device, tubal ligation, complete abstinence, barrier method (condoms, diaphragm) also in conjuction with spermicidal jelly; total abstinence). Women must have been amenorrheic for at least 12 months prior to study entry to be considered postmenopausal and to have no childbearing potential. Women of childbearing potential (menstruating within 12 months of study entry), or with no hysterectomy and age < 55, must have a negative pregnancy test at baseline.
    15. Unwilling or unable to comply with the protocol for the duration of the study.

    For the healthy control group, we will include women > 18 years old (employees of participating hospitals that voluntarily participate in the yearly influenza vaccination campaign for health care personnel) that have not been diagnosed with breast cancer, they fulfill inclusion criterion 7, and do not fulfill any of the exclusion criteria 7-15.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the study is the immunogenicity to influenza
    vaccination in breast cancer patients treated with adjuvant trastuzumab.
    The immunogenicity will be tested by using the following endpoints:
    1. Geometric mean titers of HI after vaccination, with a response defined
    as greater than or equal to a 4-fold (a sensitivity analysis will be
    performed with a threshold of 2.5) increase in a population.
    2. Postvaccination seroconversion rate (SCR) which is defined as the
    proportion of patients with a fourfold or greater increase in HI
    antibodies between baseline and day 28 ± 3 and 90 ± 7.
    3. Seroprotection rate (SPR), defined as the percentage of patients with
    a titer of least 1:40.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be drawn at three time periods in all three study
    groups: at baseline (before influenza vaccination), on day 28 ± 3 (one
    month after vaccination) and on day 90 ± 7 (3 months after
    vaccination). The measures for the primary endpoint will be evaluated at
    the above 3 timepoints.
    E.5.2Secondary end point(s)
    The tolerability (local and systemic adverse events) of the influenza
    vaccination in both patients and controls will be evaluated.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The occurrence of adverse events (AE) will be sought by non-directive questioning of the patient during visit 1 after signing informed consent and at each visit during the study. AEs of the influenza vaccination in both patients and controls will also be evaluated by using a questionnaire every week until 21 days after vaccination (day 7, 14, 21). The questionnaire will be sent by post to the participants.
    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 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and tolerability of vaccination during cancer therapy
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective open-label pilot study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    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 No
    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 end of the study for a given participant is defined as when the 3rd blood sampling is drawn which is the last visit of the subject as well.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state80
    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)
    Treatment and follow-up according to the National Guidelines for
    patients with breast cancer.
    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 Decision2016-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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