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    Summary
    EudraCT Number:2019-002971-32
    Sponsor's Protocol Code Number:PROICM2019-11PRA
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-002971-32
    A.3Full title of the trial
    A Double blind randomized phase III study of pravastatin vs placebo as primary prevention of severe subcutaneous breast fibrosis in hyper-radiosensitive identified patients with breast cancer
    Etude en double aveugle de phase III, randomisée, évaluant l’efficacité de la pravastatine vs placebo en prévention primaire de fibrose radio-induite sévère chez les patientes atteintes d’un cancer du sein à haut risque de fibrose mammaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PRAVAPREV-01
    PRAVAPREV-01
    A.3.2Name or abbreviated title of the trial where available
    PRAVAPREV-01
    PRAVAPREV-01
    A.4.1Sponsor's protocol code numberPROICM2019-11PRA
    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 SponsorInstitut Regional du Cancer de Montpellier
    B.1.3.4CountryFrance
    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 supportInstitut du Cancer de Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut du Cancer de Montpellier
    B.5.2Functional name of contact pointDr Jean Pierre BLEUSE
    B.5.3 Address:
    B.5.3.1Street Address208 rue des apothicaires
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34298
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467612344
    B.5.5Fax number0033467613023
    B.5.6E-maildrci-icm105@icm.unicancer.fr
    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 PRAVASTATINE
    D.2.1.1.2Name of the Marketing Authorisation holderPRAVASTATINE
    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.3.1Product namePRAVASTATINE
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Radio-induced fibrosis in breast cancer
    patientes présentant un risque élevée de fibrose radio-induite dans le cancer du sein
    E.1.1.1Medical condition in easily understood language
    Radio-induced fibrosis in breast cancer
    patientes présentant un risque élevée de fibrose radio-induite dans le cancer du sein
    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
    To compare the impact of Pravastatin on the occurrence of grade ≥2 breast fibrosis in a selected breast cancer patient population considered at high risk of severe breast fibrosis occurrence (identified by the NovaGray RILA Breast® test) vs placebo.
    E.2.2Secondary objectives of the trial
    •To evaluate the impact of this personalized radiotherapy on:
    - Acute and late toxicities
    - Safety
    - Local recurrence
    - Relapse free survival (RFS)
    - Breast fibrosis-free survival (BF-FS)
    - Breast fibrosis-relapse-free survival (BF-RFS)
    - Overall survival (OS)
    - Patients’ quality of life (HRQOL)
    - Cosmetic Outcomes
    •Evaluate the NovaGray RILA Breast® test performance
    •Evaluate the feasibility of a new production technique for NovaGray RILA Breast® test
    •Evaluate the NovaGray RILA Breast® test stability at 12 months
     
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Searching for a functional association between RILA and Pravastatin-responders, version 1 of 24 july 2019

    Objectives :
    -Assessment of antifibrotic activity of Pravastatine on signaling pathway into radio-induced fibrosis (Rho/ROCK/CTGF, TGF/Smad) from cutaneous superficial biopsy.
    -Assessment of interaction of pravastatine and ionizing radiation on lymphocyte T and cutaneous fibroblast in particular on the signalling pathways involved in apoptosis and inflammation
    E.3Principal inclusion criteria
    1.Women ≥ 18 years old (no age limit)
    2.Conservative breast cancer surgery
    3.High risk level of breast fibrosis identified by the centralized NovaGray RILA Breast® test
    4.Invasive carcinoma : pT1-T2; pN0 (negative sentinel nodes or axillary nodes dissection)
    5.Ductal in situ carcinoma
    6.Negative surgical margins
    7.Indication of whole breast irradiation only (with or without boost to tumor bed according to physician discretion)
    8.Only 3D-conformal RT will be allowed
    9.Blood sample allowing pravastatin use : serum creatinine ≤ 130 µmol/l; ASAT and ALAT≤ 2N; total bilirubin ≤ 1.5N; CK levels < 3 x ULN for women ≥ 70 years (at least 15 days before randomization).
    10.Negative pregnancy test in women of childbearing potential (women not of reproductive potential are female patients who are postmenopausal or permanently sterilized: e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
    11.Must be geographically accessible for follow-up
    12.Written and dated informed consent
    13.Affiliated to the French national social security system
    E.4Principal exclusion criteria
    1.Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids
    2.History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases
    3.Patients with distant metastases
    4.Indications of node irradiation (axillar or supraclavicular or mammary chain)
    5.T3-4 or N1-3 breast cancer
    6.Patients who underwent radical mastectomy
    7.Neoadjuvant systemic therapy (chemotherapy, hormonotherapy, targeted therapies)
    8.Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years
    9.Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, infection etc.) which would disrupt extended follow-up
    10.Untreated hypothyroidism
    11.Serum creatinine > 130 µmol/l; ASAT and ALAT > 2N; total bilirubin > 1.5N
    12.CK levels > 5 x ULN in women over 70 years,
    13.Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody
    14.Pregnant or breastfeeding women
    15.women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study until the last treatment dose
    16.Known hypersensitivity to pravastatine, or any constituent of the product.
    17.Patient with alcohol misuse.
    18.Patients treated with systemic investigational drugs within the past 30 days
    19.Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
    E.5 End points
    E.5.1Primary end point(s)
    breast fibrosis-free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    the time from the date of randomization to the date of the first documented grade ≥2 breast fibrosis
    E.5.2Secondary end point(s)
    1.Incidence of acute (within 3 months during and after radiotherapy) and late side effects
    2.Pravastatin tolerance
    3.Local recurrence rate
    4.Relapse-free survival (RFS) rates
    5.Breast fibrosis-free survival (BF-FS) rates
    6.Breast fibrosis-relapse-free survival (BF-RFS) rates
    7. Overall survival (OS) rates
    8.Quality of life
    9.Cosmetic outcomes
    10.Identification of clinico-biologicals parameters to improve the NovaGray RILA Breast® test performance
    11.1 x 4 ml blood sample at baseline for the evaluation of the feasibility of a new production technique for NovaGray RILA Breast® test
    12.1 x 4 ml blood sample at 12 months for the evaluation of NovaGray RILA Breast® test stability
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.side effects is assessed and graded according to the NCI-CTCAE v5.0 scale.The most severe grade observed during the period per patient will be reported.
    2.Tolerance is assessed and graded according to the NCI-CTCAE v5.0 scale
    3.Local recurrence rate from the date of randomization to 1, 2, 3, 5 and 10 years
    4, 5, 6.the rates are defined as the time from the date of randomization to the date of the first relapse
    7. is defined as the time from the date of randomization to the date of death
    8. is assessed from the date of randomization to follow-up 5 years
    9.is assessed from the date of randomization to 2 years after the end of treatment
    10. is defined from the date of randomization to the end of study
    11.is assessed at Baseline
    12.is assessed at 12 month after randomisation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned12
    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 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
    Last visit of the last subject included in the study (follow -up 10 years)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state400
    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 Decision2020-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-23
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