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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-005544-17
    Sponsor's Protocol Code Number:EMR 200038-010
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-005544-17
    A.3Full title of the trial
    A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally
    advanced, recurrent, or metastatic breast cancer
    STRIDE - STimulating immune Response In aDvanced brEast cancer
    A.3.2Name or abbreviated title of the trial where available
    STRIDE
    A.4.1Sponsor's protocol code numberEMR 200038-010
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameL-BLP25 (Stimuvax®; BLP25 liposome vaccine)
    D.3.2Product code EMD 531444
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeEMD 531444
    D.3.9.3Other descriptive nameL-BLP25
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.77
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Endoxana Injection 1g
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Health Care Ltd.
    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 nameEndoxana Injection 1g
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCyclophosphamide
    D.3.9.1CAS number 50-18-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary
    Demonstration of superior efficacy (as measured by PFS time) of L-BLP25 in combination with hormonal treatment (HT) over placebo plus HT, when used for first-line therapy of hormone receptor-positive (ER+ and/or PgR+), inoperable locally advanced, recurrent, or metastatic breast cancer (BRCA).
    E.2.2Secondary objectives of the trial
    Secondary
    • Safety and Tolerability;
    • Overall Survival (OS) Time;
    • Objective Tumor Response;
    • Duration of Response;
    • Clinical Benefit;
    • Time to Progression (TTP);
    • Time to Chemotherapy;
    • Quality of Life (QOL);
    • Healthcare Resource Utilization (HRU);
    • Serum CA 15-3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, all of the following inclusion criteria must be fulfilled:
    • Written informed consent given before any study-related activities are carried out
    • Female inpatient or outpatient
    • ≥ 18 years of age
    • Postmenopausal, defined by at least one (1) of the following:
    􀂃 No spontaneous menses for at least five years
    􀂃 Spontaneous menses within the past five years but amenorrheic for at least
    12 months and luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
    within the postmenopausal normal range (Subjects who are amenorrheic
    following a hysterectomy but who have not had bilateral salpingo-oophorectomy
    are not eligible unless they have additional biochemical evidence of menopause as
    reflected by ovarian suppression and FSH and plasma estradiol levels in the
    postmenopausal range.)
    􀂃 Prior bilateral oophorectomy
    􀂃 Prior bilateral ovarian irradiation and castration, amenorrheic for at least three
    months, and FSH levels > 40 IU/L
    􀂃 No menstrual period for 12 months or longer and a serum estradiol level in the
    postmenopausal range (≤ 22 pg/mL)
    • ER+ and/or PgR+, histologically or cytologically confirmed primary carcinoma of
    the breast (institutional pathological diagnosis of BRCA is acceptable)
    • Expressing at least one of the following five HLA haplotypes, as centrally assessed
    by HLA genotyping from whole blood: HLA-A2, -A3, -A11, -B7, or -B35
    • Locally advanced, recurrent, or metastatic BRCA (Subject must have at least one
    lesion not located in bone).
    • Measurable disease by RECIST, and inoperable (not eligible for breast-conserving
    surgery or mastectomy) with no reasonable expectation of surgery for cure now or in
    the future.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Life expectancy of at least 12 weeks
    • Adequate hematologic, hepatic, and renal function within two weeks prior to
    initiation of therapy, as defined by the following:
    􀂃 White blood cells (WBCs) ≥ 2500/mm3; absolute neutrophils ≥ 1500/mm3;
    platelets ≥ 100,000/mm3
    􀂃 Hemoglobin ≥ 9 g/dL
    􀂃 Bilirubin ≤ 1.5 × the upper limit of normal (ULN), or ≤ 5 × ULN in case of
    hepatic metastasis
    􀂃 Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
    ≤ 2.5 × ULN, or ≤ 5 × ULN in case of hepatic metastasis
    􀂃 Creatinine ≤ 1.5 × ULN
    􀂃 International Normalized Ratio (INR), prothrombin time (PT), and partial
    thromboplastin time (PTT) in the normal range
    • Willingness to comply with study protocol requirements
    E.4Principal exclusion criteria
    Subjects are not eligible for this study, if they fulfill one or more of the following
    exclusion criteria:
    Disease Status
    • PD either during HT for early breast cancer (adjuvant therapy) or within 12 months
    of completing such therapy
    • Human epidermal growth factor receptor 2-positive (HER2+) BRCA, defined as
    follows:
    􀂃 Immunohistochemistry (IHC) staining of 3+ (uniform, intense membrane staining
    of > 30% of invasive tumor cells), or
    􀂃 Fluorescent in situ hybridization (FISH) result > 6 HER2 gene copies per nucleus,
    or
    􀂃 FISH ratio (HER2 gene signals to chromosome 17 signals) > 2.2.
    Historical data will routinely be confirmed by local pathology laboratories in case
    of “equivocal” historical results as follows:
    o By validated FISH-test if HER2 protein expression is equivocal (i.e.,
    IHC 2+) or, if appropriate
    o By validated IHC if HER2 gene amplification is “equivocal” (i.e.,
    FISH ratio 1.8-2.2 or HER2 gene copy 4.0-6.0)
    • Autoimmune disease that in the opinion of the investigator could compromise the
    safety of the subject in this study. (Exception will be granted for well-controlled
    Type I diabetes mellitus.)
    • Recognized immunodeficiency disease, including cellular immunodeficiencies,
    hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital
    immunodeficiencies
    • Known active hepatitis B infection or carrier state and/or hepatitis C infection,
    known human immunodeficiency virus (HIV) infection, or any other infectious
    process that in the opinion of the investigator could compromise the subject’s ability
    to mount an immune response, or could expose her to the likelihood of more and/or
    severe side effects
    • Past or current history of malignant neoplasm other than BRCA, except for
    curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or
    other cancer curatively treated and with no evidence of disease for at least five years
    Pre-therapies
    • Receipt of immunotherapy (e.g., interferons; tumor necrosis factor; interleukins;
    growth factors granulocyte macrophage-colony stimulating factor [GM-CSF],
    granulocyte-colony stimulating factor [G-CSF], macrophage-colony stimulating
    factor [M-CSF], or monoclonal antibodies), or chemotherapy, within four weeks (28days) prior to randomization. Note: Subjects who have received monoclonal
    antibodies for imaging are eligible.
    • Prior receipt of investigational systemic drugs (including off-label use of approved
    products) or any kind of systemic treatment (chemotherapy, HT, or immunotherapy)
    for inoperable, locally advanced, recurrent, or metastatic breast cancer
    • Prior radiotherapy to the site of cancer, if only one site will be used for evaluation of tumor response.
    Prior use of bisphosphonates or concurrent use while on study treatment is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is PFS time. For this study, all HTs for front-line
    therapy of advanced BRCA were approved based on surrogate endpoints (either response rate, response rate and TTP, or TTP). In current guidelines, PFS time is often preferred over TTP as a surrogate endpoint in oncology studies. As PFS time is also considered an acceptable endpoint in situations where subsequent therapies may have an impact on OS time, PFS time was chosen as the primary endpoint of this study.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    See protocol section 5.1.1 (page 40)
    If the study is not terminated for a reason given in the protocol section 5.3.3.3, the study will end when each of the following is fulfilled:
    • The last subject has received the last dose of study medication, and has undergone a 6-week safety follow-up.
    • The study objectives have been answered.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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.1.3Elderly (>=65 years) Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1200
    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)
    See protocol section 5.1.2: Subjects will be referred to their managing physicians for further treatment options.
    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 Decision2009-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-10
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