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    Summary
    EudraCT Number:2016-004151-79
    Sponsor's Protocol Code Number:TRIO030
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-004151-79
    A.3Full title of the trial
    A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
    A.4.1Sponsor's protocol code numberTRIO030
    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 SponsorTranslational Research in Oncology (TRIO)
    B.1.3.4CountryCanada
    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 supportBayer Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTranslational Research In Oncology (TRIO)
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address11, rue Watt
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number33158 10 09 09
    B.5.5Fax number33158 10 09 10
    B.5.6E-mail030@trioncology.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 No
    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 namedarolutamide
    D.3.2Product code ODM-201
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeODM-201
    D.3.9.3Other descriptive namedarolutamide
    D.3.9.4EV Substance CodeSUB71144
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Early 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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006192
    E.1.2Term Breast cancer NOS
    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 identify the molecular alterations that occur in human breast cancer (BC)tissue, following short-term exposure to darolutamide in female subjects with early breast cancer (EBC).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of short-term exposure to darolutamide in female subjects with early breast cancer (EBC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated PICF obtained prior to initiation of any study-specific procedure and treatment.

    2. Female ≥ 18 years old.

    3. Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which NAST is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.

    4. Known ER, PgR and HER2 statuses.

    5. Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: subjects with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):
    •T1 with T ≥1.0 cm, T2 or T3 by at least one radiographic or clinical measurement
    •Either clinically positive (N1 only) or clinically negative axillary nodes (N0)
    •M0

    6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

    7. Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:
    • Hematology: Haemoglobin ≥ 9.0 g/dl; ANC ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L
    •Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (or ≤ 3 times ULN for subjects with documented Gilbert’s syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)
    •Renal function: Creatinine ≤ 2.0 × ULN

    8. No more than 7 days must elapse from the confirmation of BC diagnosis (i.e. availability of pathological report) to the time of the first intake of darolutamide.

    9. WoCBP* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of ODM-201.

    10. For WoCBP* negative serum pregnancy test within 7 days of enrollment.

    11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.

    * Note: Women of childbearing potential (WoCBP) are any women between menarche and menopause who have not been permanently sterilized, capable of procreation. Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation/occlusion. Postmenopause is defined as:
    - Bilateral oophorectomy
    - Age ≥ 60
    - Age < 60 and amenorrheic for ≥ 12 months in the absence of an alternative medical cause and FSH and estradiol in postmenopausal ranges.
    E.4Principal exclusion criteria
    1. Any T0, Tis, T1 < 1.0 cm, T4; or N2-3; or M1 BC.

    2. Bilateral invasive BC.

    3. Patient that underwent excisional biopsy of the primary tumor.

    4. Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and/or refusal of patient to undergo corresponding biopsy in case NAST is planned.

    5. Prior or concurrent systemic anticancer therapy for BC (immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).

    6. Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive BC.

    7. Prior or concurrent treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).

    8. Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.

    9. Prior or concurrent treatment with AR antagonists or CYP17 enzyme inhibitor.

    10. Use of other investigational drug within 28 days of enrollment.

    11. Major surgery* within 28 days before enrollment.

    12. Any concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A subject with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.

    13. Severe or uncontrolled concurrent disease, infection or comorbidity.

    14. Known active viral hepatitis, HIV or chronic liver disease.

    15. Other serious illness or medical condition within 6 months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke.

    16. Any contraindication to oral agents or gastrointestinal disorder or procedure which expects to interfere significantly with absorption of protocol treatment.

    17. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

    18. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

    19. Known allergy to darolutamide or any of the excipients.

    20. Pregnant or lactating subjects.

    * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability.
    E.5 End points
    E.5.1Primary end point(s)
    No efficacy assessments are planned in this study. With the exception of the examination of breast and regional lymph nodes. Disease assessments will be conducted according to the standard of care (SoC) at the study site.

    As the primary objective of this trial is to evaluate molecular alterations occurring in BC tissue following short-term darolutamide administration (there will be no PK analysis).

    The molecular analyses will be completed on the evaluable population. Descriptive statistics will be used to compare the pre-and post molecular findings.

    A correlation analysis between the molecular alterations from the baseline tumor samples and the sample collected during the definitive surgery following administration of darolutamide will be conducted.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 subjects (a minimum of 8 evaluable patients and up to 20 patients in each BC subtype: triple-negative, ER+/HER2 negative, HER2 positive) will be required for the performance of the molecular studies and possible hypothesis generation.
    E.5.2Secondary end point(s)
    The assessment of safety will be performed using the safety population, and will be based mainly on the frequency of AEs. The latest version of the Medical Dictionary for Regulatory Activities (MedDRA) will be used to code all AEs to a preferred term and system organ class. AEs will be graded using the NCI CTCAE version 4.03 or according to other applicable grading if an AE is not specifically listed in the NCI CTCAE.

    Laboratory parameters, also graded according to the NCI CTCAE, will be summarized at baseline, along visits, and at the EoS visit by each BC subtype. Tables of shifts in toxicity will be provided.

    ECOG will also be summarized at baseline, along visits and at the EoS visit by BC subtype. Tables of shifts in toxicity will be provided, when applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The assessment of safety will be made on the "safety population" and will be based mainly on the frequency of AEs. The "safety population" includes ALL subjects who have taken at least one tablet of darolutamide.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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
    TRIO030 is a pilot/exploratory trial intended to study the biological mechanisms in which darolutamide targets the androgen receptor (AR) in BC and its potential role for this disease. Molecular profiling of tumor samples before and after darolutamide treatment may permit the identification of patients likely or unlikely to respond to this agent, based on the biological and molecular characteristics of their tumors.
    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 No
    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.8.3 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 No
    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
    Canada
    United States
    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 years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 60
    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 receive standard of care as expected, however, for subjects experiencing protocol treatment-related AEs/SAEs that are ongoing at the time of the end-of study visit, monitoring of these events will continue as clinically indicated until (a) the events have resolved or (b) the events have reached a status which, in the Investigator’s opinion, is unlikely to resolve due to the nature of the condition and/or the subject’s underlying disease.
    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 Decision2017-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-28
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