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    Summary
    EudraCT Number:2011-004822-85
    Sponsor's Protocol Code Number:ABCSG-34
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-30
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-004822-85
    A.3Full title of the trial
    A prospective, open, randomized, phase-II study of a therapeutic cancer vaccine (L-BLP25, Stimuvax®) in the pre-operative treatment of women with primary breast cancer
    Eine prospektive, offene, randomisierte Phase II-Studie eines therapeutischen Krebs Vakzins (L-BLP25; Stimuvax®) in der pre-operativen Therapie von Frauen mit primärem Brustkrebs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open, randomized, phase-II study of a therapeutic cancer vaccine (L-BLP25, Stimuvax®) in the pre-operative treatment of women with primary breast cancer
    Eine prospektive, offene, randomisierte Phase II-Studie einer therapeutischen Impfung gegen Krebs (L-BLP25, Stimuvax®) in der präoperativen Behandlung von primärem Brustkrebs
    A.3.2Name or abbreviated title of the trial where available
    ABCSG-34
    A.4.1Sponsor's protocol code numberABCSG-34
    A.5.4Other Identifiers
    Name:Merck CodeNumber:EMR63325-603
    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 SponsorABCSG (Austrian Breast & Colorectal Cancer Study Group)
    B.1.3.4CountryAustria
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABCSG (Austrian Breast & Colorectal Cancer Study Group)
    B.5.2Functional name of contact pointTrial Office
    B.5.3 Address:
    B.5.3.1Street AddressNussdorfer Platz 8
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1190
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314089230
    B.5.5Fax number+4314090990
    B.5.6E-mailinfo@abcsg.at
    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®)
    D.3.2Product code EMD531444
    D.3.4Pharmaceutical form Powder for suspension 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 INNL-BLP25 reconstituted
    D.3.9.3Other descriptive nameL-BLP25 reconstituted
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number23.395
    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.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 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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    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) 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 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.IMP: 3
    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 Letrozol Sandoz
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameLetrozol Sandoz
    D.3.2Product code na
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) 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 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.IMP: 4
    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 AuthorisationAustria
    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 nameEpirubicin
    D.3.2Product code E
    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 INNEPIRUBICIN
    D.3.9.1CAS number 56420-45-2
    D.3.9.2Current sponsor codeE
    D.3.9.4EV Substance CodeSUB06571MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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 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.IMP: 5
    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 AuthorisationAustria
    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 nameCyclophosphamide
    D.3.2Product code C
    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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.2Current sponsor codeC
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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 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.IMP: 6
    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 AuthorisationAustria
    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 nameDocetaxel
    D.3.2Product code D
    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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.2Current sponsor codeT
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 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
    primary breast cancer
    primäres Mammakarzinom
    E.1.1.1Medical condition in easily understood language
    breast cancer
    primäres Brustkrebs
    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 compare efficacy of pre-operative standard of care treatment with or without a therapeutic cancer vaccine (L-BLP25), measured by Residual Cancer Burden (RCB) at the time of surgery
    E.2.2Secondary objectives of the trial
    • to compare the efficacy of pre-operative standard of care treatment with or without a therapeutic cancer vaccine (L-BLP25), when measured by pathological complete remission (pCR, =absence of invasive cancer cells in surgical specimen) at the time of surgery.
    • to detect differences in the efficacy between reverse versus conventional sequenced chemotherapy with or without L-BLP25, when measured by RCB.
    • to compare safety and tolerability of standard of care pre-operative treatment with or without a therapeutic cancer vaccine (L-BLP25).
    • to compare differences in tumor associated lymphocytes and ki67 status along the course of therapy in women who receive standard of care pre-operative treatment with or without L-BLP25
    • to evaluate Quality of Life in women treated with our without a therapeutic cancer vaccine (L-BLP25)
    • additional sensitivity analyses of subgroups according to pre-defined study populations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Pre- and postmenopausal female patients with core-biopsied, early primary invasive breast cancer of any clinical and/or radiological tumor stage (except T4d, inflammatory breast cancer) scheduled to receive pre-operative therapy.
    • One core from the biopsy will be dedicated to analyses of a validated gene expression array
    • Patients must fulfill the following criteria:
    -Postmenopausal AND E+++ or [E++ and ki67<14%] AND G 1,2,X AND scheduled for endocrine therapy as standard of care (34 A)
    OR
    -Triple negative OR E- OR E+ OR [E++ and ki67>14%] OR G3 OR premenopausal status AND scheduled for anthracyclin-taxan-based chemotherapy as institutional standard of care (34 B)
    *Note: for ki67 status determination any antibody can be used; scores for determination of E/PR receptor status according to institutional standard
    • No distant metastasis (M0) or secondary carcinoma as assessed clinically and radiologically (X-Ray or CT or MRI or PET) within 3 months prior randomization
    • Age ≥ 18
    • WHO performance status 0 or 1
    • No prior chemotherapy, radiotherapy, or endocrine therapy for invasive breast cancer
    • Willingness to undergo Sln and/or ALND Procedure (Sentinel/Axillary Lymph node dissection) acc. to institutional standard
    • No medical and/or cardiologic contraindication to receive an anthracyclin- and taxan-containing chemotherapy or endocrine therapy regimen
    • Adequate Hematologic function (≤ 14 days prior to randomization)
    • Adequate Renal function (≤ 14 days of randomization)
    • Adequate Hepatic function (≤ 14 days of randomization)
    • Adequate cardiac function: Normal cardiac function must be confirmed by LVEF (Echocardiography or MUGA scan) for chemotherapy treatment only. The result must be above 50% or above the lower normal limit of the institution. In addition each of the following criteria must be met:
    o NYHA<III
    o No uncontrolled angina, arrhythmia, hypertension
    o No myocardial infarction over the last 6 months as confirmed by ECG
    • Negative pregnancy test (serum or urine) max. 7 days prior to randomization for pre-menopausal patients. In postmenopausal patients, no pregnancy tests must be performed at any time, requested that
    a) FSH and estradiol are in postmenopausal range and/or
    b) the patient is amenorrhoeic for > 12 months with uterus still in situ and/or
    c) the patient is 61 years of age or older.In this situation, the investigator must document why the pregnancy test was not performed.
    • In all premenopausal patients adequate conception with non-hormonal methods (e.g. condoms, non-levonorgestrel-releasing intrauterine devices, diaphragms, vasectomized partner, or abstinence) is mandatory during study duration until at least 30 days after the last vaccination of L-BLP25.
    • Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form and able to comply with the required treatments, visits and assessments
    • Informed consent signed prior to randomization and prior to any study specific procedure (study specific baseline blood sample)
    E.4Principal exclusion criteria
    • HER2 overexpression (+++)
    • Past or current history of other neoplasms in the last 5 years, except basal cell cancer of the skin, non-melanoma skin cancer and in situ cancer of the cervix
    • Any medical condition rendering the patient unfit for standard of care pre-operative therapy (chemotherapy or endocrine therapy in the respective SoC treatment group)
    • Concurrent or prior systemic antitumor therapy < 5 years
    • Patients scheduled for any chemotherapy other than EC->T or T->EC
    • Clinically significant cardiovascular disease (including unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) < 1 year before randomization
    • Known autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn´s disease, multiple sclerosis, ankylosing spondylitis)
    • Severely compromised haematopoietic function
    • Known immunodeficiency disease (cellular immunodeficiency, hypogammaglobulinaemia, dysgamaglobulinaemia)
    • Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
    • Active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to randomization
    • Major surgery, or significant traumatic injury occurring within 4 weeks prior randomization
    • Use of i.v. or s.c. immune modulators (Viscum album etc.)
    • Pre-treatment with L-BLP25
    • Concurrent treatment with another approved or investigational anticancer treatment is not permitted, excluding therapy as permitted in the protocol
    • Concurrent participation in another clinical trial with the same endpoints is not permitted
    • Pregnancy or breastfeeding
    • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP/NIMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrollement into this study
    • Known hypersensitivity against taxanes and/or epirubicin and/or cyclophosphamide or aromatase inhibitors in the respective SoC treatment group
    • Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, inhalational use, prevention or treatment of acute hypersensitivity reactions, treatment of nausea / vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose (< 20 mg methylprednisolone or equivalent)
    E.5 End points
    E.5.1Primary end point(s)
    Histo-pathological response to pre-operative standard of care treatment with or without L-BLP25 therapy when measured by Residual Cancer Burden (RCB0/I versus RCBII/III) at the time of surgery
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the time of surgery
    E.5.2Secondary end point(s)
    • Proportion of pathological complete remission (pCR; = absence of invasive cancer cells in surgical specimen)
    • Efficacy of reverse versus conventional sequence chemotherapy with or without L-BLP25 as measured by RCB
    • Safety and tolerability of vaccination with L-BLP25
    • Proportion of patients with lymphocyte-predominant breast cancer as measured by tumor associated lymphocytes (TAL) and changes in TAL, as well as ki67 status under tumor therapy;
    • Quality of Life (QoL)
    • Subgroup analysis according to pre-defined study populations
    E.5.2.1Timepoint(s) of evaluation of this end point
    • pCR, lymphocyte-predominant breast cancer, KI-67, RCB: at the time of surgery
    • Safety/tolerabilty: after final surgery
    • QoL: after the End of Study Visit
    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
    • tolerability
    • Quality of Life
    • sensitivity
    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
    with or without IMP (L-BLP25)
    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 concerned19
    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
    The end of trial is defined with database closure.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days14
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state400
    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)
    standard after care outside the protocol
    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 Decision2012-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-12
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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