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    Summary
    EudraCT Number:2011-001998-10
    Sponsor's Protocol Code Number:Create-01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-07-14
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-001998-10
    A.3Full title of the trial
    An International Randomized Phase II Study Comparing Early Electrochemotherapy to Delayed or No Electrochemotherapy in Patients with Cutaneous Breast Cancer Metastases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An International Study in Patients with Breast Cancer Spread to the Skin Using Electric Fields to Enhance the Efficacy of Chemotherapy
    A.4.1Sponsor's protocol code numberCreate-01
    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 SponsorDepartment of Oncology University Hospital Uppsala
    B.1.3.4CountrySweden
    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 supportBröstcancerriksorganisation
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Oncology University Hospital Uppsala
    B.5.2Functional name of contact pointJeffrey Yachnin
    B.5.3 Address:
    B.5.3.1Street AddressAkademiska sjukhuset Ing78
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75195
    B.5.3.4CountrySweden
    B.5.4Telephone number460186110000
    B.5.6E-mailjeffrey.yachnin@akademiska.se
    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 Bleomycin
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Medical AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameBleomycin
    D.3.2Product code 11056-06-7
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbleomycin
    D.3.9.1CAS number 11056-06-7
    D.3.9.2Current sponsor code2701:50, F
    D.3.9.3Other descriptive namebleomycin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000
    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 Yes
    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 that has spread to the skin
    E.1.1.1Medical condition in easily understood language
    Breast cancer that has spread to the skin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is a comparison of treatment strategies rather than single treatment modalities. The main objective is to determine if there is an advantage to giving ECT at an earlier stage in the treatment of cutaneous metastatic breast cancer compared to the usual practice of using ECT when all other treatment options have been exhausted. A potential advantage to early ECT treatment may be defined from several aspects: improved local control of metastatic growth, improved quality of life based on potentially less systemic therapy and finally health economic advantages because there is a potential for patients to delay or avoid systemic treatments if there is good local control
    E.2.2Secondary objectives of the trial
    -Local control of skin metastases over the period of six to eighteen months of follow-up.
    -Time to local treatment failure
    -Response of target lesions
    -Quality of Life using Fact B and EQ5d questionnaire
    -Retrospective health economic analysis for the two treatment arms
    -Comparison in the two study arms with respect to the types of therapy, number of changes in therapies, the number of cycles of chemotherapy and duration of endocrine therapies during the 18 months of follow-up.
    Overall survival
    Serious Adverse Events
    An assessment of pain in patients receiving ECT using the Short McGill Pain Score
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients > 18 years of age
    • Histological confirmed breast cancer
    • Metastatic breast cancer (skin lesions only are considered as metastatic disease)
    • Prior histological confirmation of at least one skin lesion
    • Skin lesions must not have a depth greater than 3 cm (measured clinically if possible otherwise on the basis of CT/ultrasound examination
    • Confluent skin metastases where individual lesions are hard to define in their entirety may not exceed a maximum area of 10 x 10 cm for each area of confluence. If there are several areas of confluence, the patient may be included in the study provided that all lesions can be treated within the time constraints of a single ECT session (20 minutes).
    • Not more than ten skin lesions. Each area of confluence is considered as one lesion.
    • A single skin lesion may not exceed 5 cm
    • Patients may not have received more than one line of systemic treatment (chemotherapy or endocrine therapy) for metastatic disease following the discovery of skin metastases. Patients developing skin metastases for the first time during ongoing systemic therapy may receive one additional line of systemic treatment prior to inclusion.
    • Patients in the early ECT arm may receive any other cancer treatments at the discretion of the treating physician starting no earlier than 2 weeks following ECT. This is to ensure that patients with metastatic disease in other locations will receive treatment that is considered suitable regardless of their participation in this trial. (If 2 weeks from ECT to the start of systemic treatment is judged to be too long by the treating physician, this patient should not be entered into the trial).
    • Women of childbearing age must practice a suitable form of contraception.
    • Patients must be willing to comply with the study protocol and give their written informed consent.
    • A life expectancy of at least 6 months.
    • Patients with a ECOG performance status < 3
    • Signed Informed Consent
    E.4Principal exclusion criteria
    • Patients who have extensive and rapidly progressive visceral metastases where a delay in systemic therapy by eventual ECT is judged to not be in the patients` best interest
    • Patients, who for medical reasons, cannot be given bleomycin
    • Patients with brain metastases treated with surgery and/or radiotherapy who have progressive disease in the brain two months after treatment
    • Prior cumulative dose of bleomycin exceeding 250,000 IU/m2
    • Less than 14 days from previous cancer treatment (either local or systemic)
    • If the patient has skin lesions that are situated in close proximity to a pacemaker such that an electrical field from ECT will overlap the pacemaker, the pacemaker must be moved to another location in order for the patient to be able to participate in the study
    • Chronic renal failure (serum creatinine > 150mol/L)
    • Inadequate liver function defined as:
     ASAT or ALAT > 2.5 x ULN in the absence of liver metastases or > 5 in the presence of liver metastases
     or Bilirubin > 2 x ULN (except in the case of Gilberts Syndrome)
     or Albumin < 25 g/L
    • Inadequate bone marrow reserve defined as:
     White blood cell count < 3 X 109/L
    or Neutrophil count < 1.5 X109/L
    or Platelet count < 100 X 109/L
    • Any severe uncontrolled systemic disease.
    • Unable or unwilling to comply with the study protocol
    E.5 End points
    E.5.1Primary end point(s)
    Local control of skin metastases at six months of follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months following randomization
    E.5.2Secondary end point(s)
    Local control of skin metastases over the period of six to eighteen months of follow-up.
    • Time to local treatment failure
    • Response of target lesions
    • Quality of Life using Fact B and EQ5d questionnaire
    • Retrospective health economic analysis for the two treatment arms
    • Comparison in the two study arms with respect to the types of therapy, number of changes in therapies, the number of cycles of chemotherapy and duration of endocrine therapies during the 18 months of follow-up.
    • Overall survival
    • Serious Adverse Events
    • An assessment of pain in patients receiving ECT using the Short McGill Pain Score
    E.5.2.1Timepoint(s) of evaluation of this end point
    six to eighteen months after randomization
    Overall survival up to 24 months after randomization
    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 Yes
    E.6.13.1Other scope of the trial description
    health economics
    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 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 Yes
    E.8.2.3.1Comparator description
    any other medical treatment is allowed
    surgery/radiotherapy
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    End of trial is defined as 18 months following randomization of the last patient. Premature closure of the trial is justified due to poor inclusion. Since this research study is a comparison of treatment strategies and not individual treatments (using established therapies), no premature termination of the study is anticipated due to safety issues.
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 120
    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 different from the expected normal treatment
    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 Decision2011-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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