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    Summary
    EudraCT Number:2010-019225-33
    Sponsor's Protocol Code Number:31630
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-04-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-019225-33
    A.3Full title of the trial
    A Randomized Phase II Study Of Reirradiation And Hyperthermia Versus Reirradiation And Hyperthermia Plus Chemotherapy For Locally Recurrent Breast Cancer In Previously Irradiated Area
    A.3.2Name or abbreviated title of the trial where available
    Rehypci
    A.4.1Sponsor's protocol code number31630
    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
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    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 INNCISPLATIN
    D.3.9.1CAS number 15663271
    D.3.9.3Other descriptive nameCisplatinum
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 to mg/m2
    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 Yes
    D.3.11.13.1Other medicinal product typeChemotherapy
    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
    All patients with a local regional recurrence of invasive breast cancer in previously irradiated area with measurable lesions not suitable for resection are eligible for this trial. Patients with metastases are allowed if their life expectancy is considered 1 year or more, i.e. a limited bone metastases.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10008456
    E.1.2Term Chemotherapy single agent systemic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore if there is an indication of a positive effect on local control rate of adding Cisplatin to local reirradiation and hyperthermia to patients with local regional recurrent breast cancer in previously irradiated area
    E.2.2Secondary objectives of the trial
    - To describe the effect of adding Cisplatin to the standard treatment on acute toxicity
    - To describe the effect of adding Cisplatin to the standard treatment on clinical complete response rate
    - To explore the effect of adding Cisplatin to the standard treatment on time to disease progression local, regional or distant
    - To explore the effect of adding Cisplatin to the standard treatment on time to death by any cause
    - To describe the effect of adding Cisplatin to the standard treatment on late toxicity
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational study on PET-CT, same date/version and objectives as main study.

    Primary objectives:

    1. To compare the accuracy of GTV assessment by simulation PET-CT with conventional means, clinical assessment and conventional CT-smulation.
    2. Prognostic value of SUVmax of the simulation PET-CT in relation to local control rate
    3. Predictive value of the early response PET-CT including change in SUVmax on final response and ultimate local control
    4. To compare the accuracy of the evaluation PET-CT response assessment with the clinical and/or radiological assessment (2 months after therapy)
    5. To correlate the δ SUV (difference between SUVmax of the simulation PET and SUV-max of the evaluation PET-CT) to local control rate.

    Secondary objectives:

    1. To assess stage migration from N0 to N1-3 and/ or M0 to M1 and detect
    unexpected (for instance contralateral regional) tumour foci
    2. To asses the non-specific effects of the reirradiation and hyperthermia treatment
    on the early response PET-CT
    3. To compare the RECIST (Response Evaluation Criteria In Solid Tumours)
    criteria38 with the PERCIST (PET Response Criteria In Solid Tumours) criteria.

    Translational study on tumour biology: DNA Damage response and hypoxia, same date/version and objectives as main study.

    Objectives

    1. a. To determine the DNA damage response (DDR) by means of determination of radiation
    induced gamma-H2AX foci and expression of DNA repair proteins (BRCA1, RAD 51
    and MRE11) in biopsies irradiated ex vivo (see 10.6 tumor tissue biopsy).

    b. Determine the relation between the DDR and tumor hypoxia.

    c. Determine the treatment induced gamma-H2AX foci and DNA repair proteins in biopsies
    taken 1 week after therapy and correlate the DDR with hypoxia and treatment outcome.

    2. a. Determine the relationship between tumor hypoxia (measured by Eppendorf
    polarographic electrode system) and expression of endogenous hypoxia markers in
    plasma samples

    b. Determine the relationship between tumor hypoxia (measured by Eppendorf
    polarographic electrode system) and expression of endogenous hypoxia markers (Hif1-
    alfa and CA-9) in the tumor sample

    3. To determine the relationship between hypoxia and plasma levels of the cytokine VEGF
    and PAI-1.
    E.3Principal inclusion criteria
    • Macroscopic local regional recurrence of breast cancer in previously irradiated area, not suitable for resection
    • recurrence is measurable by clinical examination and/or radiological (CT-scan, MRI or ultrasound) assessment
    • Confirmation of diagnosis of the local regional recurrence including all subtypes of invasive adenocarcinoma by histology or FNA (fine needle aspiration)
    • Local regional recurrence of breast cancer must be treatable with radiation and hyperthermia at the discretion of the treating physician (i.e. thickness ≤ 4 cm; cross-sectional diameter ≤ 30 cm).
    • Digital photograph of recurrence
    • WBC ≥ 3,000, NG≥ 1,000, platelets ≥ 100,000, ANC ≥ 1500
    • serum bilirubin ≤ 1.5 times upper limit of normal, transaminase ≤ 3 times upper limit of normal
    • calculated creatinine clearance > 60 ml/liter (Cockroft)
    • distant metastases are allowed if life expectancy is ≥ 1 year i.e. limited bone metastases
    • Concurrent endocrine/hormonal therapy is allowed
    • ECOG performance score ≤ 2
    • Written informed consent
    • Patients must be older than 18 year
    • Patient must not be pregnant or lactating. If appropriate effective contraception must be used.
    E.4Principal exclusion criteria
    Concurrent chemotherapy other than study medication
    * Uncontrolled infection
    * Other previous malignancy that could conceivably be active.
    * Patients with pacemakers or implanted defibrillators on the same site as the treatment (if this is the case, the pacemaker or implanted defibrillator should be replaced if possible)
    E.5 End points
    E.5.1Primary end point(s)
    local control rate
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 state104
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 104
    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)
    Patients will be seen 2, 4, 6 weeks and 3, 6, 9, and 12 months following completion of protocol therapy, or earlier in case of complaints or suspicion of recurrence. If CR or PR is assessed at one of these visits the patient will be seen 4 weeks after that visit for confirmation according to the RECIST criteria39. After 1 year patients will be seen every 6 months. At each visit a digital photograph of the treated area is required.
    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 Decision2010-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-06-25
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