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    Summary
    EudraCT Number:2013-004418-17
    Sponsor's Protocol Code Number:I-BCT-1
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-02-26
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-004418-17
    A.3Full title of the trial
    Improved breast cancer therapy (I-BCT-1) in the neoadjuvant and metastatic setting: A phase 2 clinical trial protocol studying biological rationale for the optimal selection of treatment regimens.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the use of additional chemotherapy for the improvement of efficacy, and the selection of breast cancer patients for such treatment in two paitent cohorts: Before surgery in curable patients and at time of metastatic disease.
    A.4.1Sponsor's protocol code numberI-BCT-1
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportHelse SørØst HF
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointOlav Engebråten
    B.5.3 Address:
    B.5.3.1Street AddressKirkeveien 166
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number4723026600
    B.5.6E-mailolav.engebraten@rr-research.no
    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.2.1.2Country 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 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 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
    breast cancer
    E.1.1.1Medical condition in easily understood language
    breast cancer
    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
    The primary objective of the study is to determine the molecular (DNA, RNA, protein and metabolic) changes in the tumors with reference to the obtained response in the different treatment arms.

    The molecular and metabolic characteristics and changes in the tumors will be evaluated by analyses of tumor samples taken before, under (if possible) and after the scheduled treatment period using:
    • DNA analyses, including whole genome SNP and methylation analyses in addition to RNA microarray analyses
    • Protein tissue arrays, protein arrays and protein kinase activity
    • High resolution MR magnetic angle spinning (HR-MAS) analyses


    The responses will be evaluated by available imaging technologies. If possible, functional imaging technologies will also be used for response evaluation:
    • Magnetic resonance imaging (diffusion weighted and contrast enhanced MRI) and MR spectroscopy (MRS)
    • PET based imaging modalities
    E.2.2Secondary objectives of the trial
    • Analysis of the characteristics of circulating tumor-DNA in plasma samples, circulating tumor cells (CTC) in peripheral blood, at the time points for the tumor sampling with comparison to the tumor analysis and according to the different treatment arms.
    • Course of fatigue during different treatment regimens and predictors of chronic fatigue after treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort I: Patients with large (radiologic measureable tumor > 2.0 cm) HER2 negative mammary carcinomas in the following categories are eligible for inclusion into the study:
    • T2 tumors with:
    o Ki67 labeling index ≥ 20%
    or
    o ER positive and Progesterone receptor negative status
    or
    o grade 3 tumors
    • T3-T4 tumors with Ki67 ≥ 15%.
    The patients should not have received previous treatment for the current disease and should be without signs of metastatic disease as determined by liver ultrasound or CT scan and bone scintigraphy or MRI.

    Cohort II: Patients with evaluable metastatic disease from breast carcinoma according to the RECIST criteria, AND elegible for biopsy of the metastatic tumor for diagnosis and research purposes before, during and after therapy.

    1. Written informed consent obtained prior to any study-specific procedure
    2. Female or male age 18 years
    3. Able to comply with the protocol
    4. Histologically or cytologically confirmed, HER2-negative, men or women with breast
    adenocarcinoma
    5. WHO performance status ≤ 2
    6. Adequate hematological function
    Absolute neutrophil count (ANC) ≥1.0 x 109/L
    AND
    Platelet count ≥100 x 109/L
    AND
    Hemoglobin ≥ 10 g/dL (may be transfused to maintain or exceed this level)
    7. Adequate liver function
    Total bilirubin <1.5 x upper limit of normal (ULN)
    AND
    AST, ALT <2.5 x ULN (in cohort I)
    AST, ALT <5 x ULN (in cohort II)
    8. Adequate renal function
    Serum creatinine ≤1.25 x ULN or calculated creatinine clearance ≥50 mL/min
    9. Normal baseline cardiac function (LVEF) as measured by MUGA or ECHO
    10. Women should not be pregnant or breast-feeding. Women with an intact uterus
    (unless amenorrhoeic for the last 24 months and premenopausal levels of FSH, LH
    and oestradiol) must have a negative serum pregnancy test within 28 days prior to
    inclusion into the study.
    E.4Principal exclusion criteria
    1. Previous chemotherapy treatment for localized breast cancer less than 24 months before inclusion into study (cohort I) or metastatic breast cancer treated with taxane (cohort II).
    2. Other earlier or concomitant carcinoma less than five years prior to the breast cancer diagnosis, except for BCC, in situ cervix cancer or breast cancer
    3. Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
    4. Treatment with any other investigational agent, or participation in another clinical intervention trial within 21 days prior to enrolment
    5. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
    E.5 End points
    E.5.1Primary end point(s)
    • Alteration in the DNA profiles, SNP analysis and presence of different tumor cell clones as verified by the difference in DNA analysis in the tumors of the patients in the different treatment groups related to the particular clinical responses with emphasis on responses (complete response (pCR) or partial responses) in the breast and in the lymph nodes or objective measured responses (OR) for metastatic patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 weeks of treatment.
    E.5.2Secondary end point(s)
    • Molecular changes in the protein kinase expression, mRNA/miRNA expression and protein expression and metabolome in the different treatment groups.
    • Treatment induced changes and characteristics in circulating tumor DNA and circulating tumor cells in peripheral blood compared to tumor response.
    • Response rate in the treatment groups.
    • Difference in levels of fatigue between treatment arms.
    • Host-related, tumor-related and treatment-related factors predicting chronic fatigue.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 24 weeks of treatment.
    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 No
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 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 state210
    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)
    Normal treatment for the respective condition
    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 Decision2014-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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