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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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:2012-003058-10
    Sponsor's Protocol Code Number:IBCSG_42-12/BIG_2-12
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-003058-10
    A.3Full title of the trial
    A randomized phase II study evaluating different schedules of nab-Paclitaxel in metastatic breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating different treatment plans of the medication nab-Paclitaxel, a chemotherapeutic agent in patients with breast cancer that has spread to other parts of the body.
    A.3.2Name or abbreviated title of the trial where available
    SNAP (Schedules of nab-Paclitaxel)
    A.4.1Sponsor's protocol code numberIBCSG_42-12/BIG_2-12
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01746225
    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 SponsorInternational Breast Cancer Study Group (IBCSG)
    B.1.3.4CountrySwitzerland
    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 supportCelgene International Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInternational Breast Cancer Study Group (IBCSG)
    B.5.2Functional name of contact pointIBCSG Coordinating Center
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4131389 93 91
    B.5.5Fax number+4131389 93 92
    B.5.6E-mailibcsgcc@ibcsg.org
    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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited, Uxbridge, UK
    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.3.4Pharmaceutical form Powder for suspension 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.13.1Other medicinal product typeIMP contains an excipient of biological origin, albumin, a non-active stabilising agent. It is derived from human blood subject to approved donor screening and product manufacturing processes.
    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 or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer who have not received chemotherapy for metastatic breast cancer.
    E.1.1.1Medical condition in easily understood language
    Patients recently diagnosed with breast cancer that has spread to other parts of the body (metastatic), for which systemic therapy is needed and have not yet received chemotherapy.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of three different schedules of nab-Paclitaxel administration, as measured by progression-free survival (PFS), using the historical reference of PFS of docetaxel for first-line treatment of metastatic breast cancer.
    E.2.2Secondary objectives of the trial
    • To evaluate:
    -Tolerability
    - Feasibility
    - Disease response according to RECIST criteria, including disease
    control rate
    - Overall survival
    • To explore the changes in quality of life (QL) over time until treatment discontinuation.
    • To investigate the prognostic role of putative markers (SPARC and caveolin) and assess any change in the expression of SPARC and caveolin between primary and the metastatic sites.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
    • Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
    • Female aged 18 years or older.
    • Life expectancy > 3 months.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
    • Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
    • If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
    • Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
    • Normal hematologic status. Must meet all criteria: absolute neutrophil count ≥ 1500/mm3 (1.5 x 109/L), platelets ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL (≥ 90 g/L)).
    • Normal renal function (serum creatinine ≤ 1.5 ULN or calculated creatinine clearance ≥ 50mL/min according to the Cockcroft and Gault formula).
    • Normal liver function. Must meet all criteria: ALT (SGPT) and AST (SGOT) ≤ 3 × upper limit of normal (ULN) (without liver metastases; total bilirubin ≤ 1.5 mg/dL;. Exceptions: If the patient has liver metastases, ALT (SGPT) and AST (SGOT) must be ≤ 5 × ULN; total bilirubin ≤ 1.5 mg/dL. If the patient has Gilbert’s disease higher bilirubin is acceptable (≤ 3 mg/dL)
    • Normal cardiac function defined as left ventricular ejection fraction within the institutional range of normal as measured by MUGA or echocardiogram.
    • Women of child bearing potential must have documented negative pregnancy test within 2 weeks prior to randomization and agree to acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug. If for any reason the administration of first dose of trial treatment is not within 2 weeks of the pregnancy test, a second pregnancy test should be performed within two weeks of day 1 of cycle 1.
    • Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
    • Completed baseline Quality of Life Form.
    • The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
    • Availability of an FFPE block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
    • Written consent to pathology material submission, indicating the patient has been informed of and agrees to tissue material use, transfer and handling, must be signed and dated by the patient and the Investigator prior to randomization.
    E.4Principal exclusion criteria
    • Any prior chemotherapy for metastatic breast cancer.
    • Presence of CNS metastasis.
    • Peripheral neuropathy grade 2 or higher (CTCAE version 4).
    • Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
    • Pregnant or lactating.
    • Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
    • Any concurrent condition which in the Investigator’s opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
    • Contraindications or known hypersensitivity to the study medication or excipients.
    • The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
    • Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS): time from randomization to documented progressive disease according to RECIST criteria or death, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint of PFS will be evaluated among each of the three treatment arms separately, in three independent tests, and compared to the historic PFS of first-line docetaxel. PFS distribution will also be summarized separately by different starting dose in induction (150mg/m2 and 125mg/m2).
    The target number of events per group is 63.
    E.5.2Secondary end point(s)
    • Tolerability: adverse events according to CTCAE v4
    • Feasibility: completing treatment according to the protocol for at least 24 weeks
    • Disease control: overall response or stable disease (or non-CR/non-PD for patients with non-measurable disease) or better (i.e., partial or complete response) according to RECIST criteria for a duration of ≥24 weeks
    • Overall survival: time from randomization to death from any cause
    • QL: primary endpoint physical well-being
    • Prognostic markers: SPARC and caveolin expression
    E.5.2.1Timepoint(s) of evaluation of this end point
    The toxicities, feasibility, OS, disease control rate and other measures of disease response will be evaluated for each treatment arm separately and will also be summarized separately by different starting dose in induction (150mg/m2 and 125mg/m2).
    The primary quality of life endpoint is physical well-being. The change in QL over time until treatment discontinuation for patients on each arm and on the different starting dose in induction (150mg/m2 and 125mg/m2)
    will be explored using repeated measures modeling.
    In translational research, on FFPE material from the primary tumor and metastatic sites separately, it will be evaluated whether SPARC and caveolin are prognostic markers for PFS in women with metastatic breast cancer using log-rank tests and Cox regression analysis.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Hungary
    Ireland
    Italy
    Slovenia
    Spain
    Switzerland
    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
    Randomization of 258 patients during approximately 24 to 26 months, with an additional 16 to 18 months of follow up after the last patient is entered. The end of the trial therefore will be approximately 4 years after randomization of the first patient.
    All patients will be followed up until approximately 18 months following the enrollment of the last Patient to reach the target number of events (maximum of 42 months, minimum of approximately 18 months).
    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 months0
    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 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.1.2.1Number of subjects for this age range: 212
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 258
    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)
    If at the end of the trial a patient has not progressed and wants to continue nab-Paclitaxel, the agent will be provided until progressive disease. In this case, adverse events, serious adverse events, treatment, and concomitant medications will continue to be collected.
    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 Decision2013-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-16
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