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    Summary
    EudraCT Number:2009-009598-90
    Sponsor's Protocol Code Number:91782
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-009598-90
    A.3Full title of the trial
    An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety of gadobutrol 1.0 molar (Gadovist®) for breast MRI
    A.4.1Sponsor's protocol code number91782
    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 SponsorBayer Health Care AG (study performed by Bayer Schering Pharma AG)
    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 Yes
    D.2.1.1.1Trade name Gadovist® 1.0 mmol/ml, solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGadovist® 1.0 mmol/ml, solution for injection
    D.3.4Pharmaceutical form 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 INNgadobutrol
    D.3.9.1CAS number 138071-82-6
    D.3.9.2Current sponsor codeBay86-4875
    D.3.9.3Other descriptive nameGADOBUTROL
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with histologically confirmed breast cancer referred to MRM prior to surgery after XRM.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012992
    E.1.2Term Digital mammography
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    the primary objectives of this study are to demonstrate:
    1. Superiority of combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM
    2. Superiority of combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM
    Based on the categorical accuracy in determination of the extent of malignant breast disease on breast region level with 3 categories (unifocal, multifocal malignant disease or no malignant disease present) and verified by the predefined SoT (histopathology or alternatively XRM plus ultrasound)
    E.2.2Secondary objectives of the trial
    1. Combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM
    2. Combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM
    3. Combined unenhanced and gadobutrol-enhanced MRM plus XRM versus XRM alone
    Based on:
    - Categorical accuracy by descriptive statistics using breast regions with SoT based on histology only
    - Sensitivity and specificity for malignant breast disease on breast region level for disease / no disease
    - Sensitivity and specificity for unifocal malignant breast disease on breast region level for unifocal disease / no unifocal disease
    - Sensitivity and specificity for multifocal malignant breast disease on breast region level for multifocal disease / no multifocal disease
    - Accuracy of the presence of the multicentric malignant disease "Yes/No" per breast
    - Accuracy of the presence of bilateral malignant disease "Yes/No" per patient
    - Confidence in diagnosis on breast region level
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is at least 18 years of age.
    2. Has recent histologically proven diagnosis of breast cancer after having obtained XRM of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced MRM prior to surgery of the breast.
    3. If female, a digital XRM is required if any of the following criteria is met:
    a. Patient is younger than 50 years;
    b. Patient has heterogeneously or extremely dense breasts (based on the quantitative criteria for the BI-RADS mammographic density categories of 51%-75% for heterogeneously dense, and >75% dense for the extremely dense category);
    c. Is not post-menopausal (post-menopause defined as at least 12 month prior to inclusion without menstruation).
    4. Is willing to undergo the contrast-enhanced MRM examinations with gadobutrol.
    5. Is willing and able to complete all study procedures specified in the protocol.
    6. If female, patient is either not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test within 1 hour prior to the administration of gadobutrol.
    7. If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
    8. Has an estimated glomerular filtration rate (eGFR) value ≥60 mL/min/1.73m² derived from a serum creatinine result within 2 weeks prior to study enrollment.
    9. Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate in writing.
    E.4Principal exclusion criteria
    1. Is a female patient who is pregnant or lactating.
    2. Has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study.
    3. Has been previously enrolled in this study.
    4. Has any contraindication to the MRM examiniation (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
    5. Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
    6. Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
    7. Is considered clinically unstable or his/her clinical course during the study period is unpredictable (e.g., due to previous surgery, acute renal failure).
    8. Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [<14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (<48 hours)).
    9. Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate <60mL/min/1.73m²).
    10. Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
    11. Has received hormone replacement therapy within 4 weeks prior to study drug administration.
    12. Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application.
    13. Has prior excisional biopsy or breast surgery less than 6 month before enrollment and between XRM and study MRM.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objectives of this study are to demonstrate:
    1. Superiority of combined unenhanced and gadobutrol-enhanced MRM versus unenhanced MRM
    2. Superiority of combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM
    plus XRM
    Based on the categorical accuracy in determination of the extent of malignant breast disease on breast region level
    with 3 categories (unifocal, multifocal malignant disease or no malignant disease present) and verified by the
    predefined SoT (histopathology or alternatively XRM plus ultrasound)

    The primary efficacy variable will be:
    The determination of the extent of malignant disease assessed for each breast region (see protocol section
    8.2.2 for details) for unenhanced MRM versus combined unenhanced and gadobutrol-enhanced MRM and for
    combined unenhanced and gadobutrol-enhanced MRM plus XRM versus unenhanced MRM plus XRM as
    determined by blinded readers’ assessment.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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 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 EEA22
    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 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
    For patients not scheduled for ultrasound examination the study will end up with the 24-hour follow up.
    For patients scheduled for ultrasound examination the study will end up after the ultrasound examination is
    finished.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.3Elderly (>=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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-01-27. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 440
    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)
    Not applicable for this study.
    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 Decision2010-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-28
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