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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2020-005048-46
    Sponsor's Protocol Code Number:D9673C00007
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-01
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-005048-46
    A.3Full title of the trial
    An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously-Treated Advanced/Metastatic
    HER2-Positive Breast Cancer (DESTINY-Breast12)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the efficacy and safety of trastuzumab deruxtecan in patients With or Without Brain Metastasis Who Have Previously-Treated Advanced or Metastatic HER2 Positive Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD9673C00007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04739761
    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 SponsorAstraZeneca AB
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    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 nameTrastuzumab Deruxtecan
    D.3.2Product code DS-8201a
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNTrastuzumab Deruxtecan
    D.3.9.1CAS number 1599440-13-7
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.3Other descriptive nameT-DXd
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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. medicinal product typeAntibody drug conjugate
    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
    Treatment of patients with HER2-positive breast cancer with or without brain metastasis
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic HER2-positive 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 23.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER2 positive breast cancer
    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
    To describe the overall treatment effect of T DXd in HER2-positive MBC patients with or without baseline BM
    E.2.2Secondary objectives of the trial
    1. To describe the treatment effect on the development and progression of BM in patients with or without baseline BM using additional efficacy measurements

    2. To describe efficacy in patients with stable or untreated BM

    3. To describe the effect of T-DXd on symptoms, functioning, and HRQoL in HER2-positive MBC patients with or without baseline BM

    4. To describe the safety profile of T-DXd
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion Criteria:
    1. Pathologically documented breast cancer that:
    (a) Is unresectable/advanced or metastatic, and
    (b) Has confirmed HER2-positive status as determined according to ASCO/CAP guidelines (Wolff et al, 2018) evaluated at a local laboratory
    2. Participant must have either:
    (a) No evidence of BM, or
    (b) Untreated BM on screening contrast brain MRI / CT scan
    (i)not needing immediate local therapy, or
    (ii)For participants with untreated CNS lesions:
    - if lesion ≤ 2 cm, no discussion with study physician is required prior to enrollment
    - if lesion is > 2.0 cm, discussion with and approval from the study physician is required prior to enrollment, or
    (c) Previously treated stable or progressing BM
    (i) Previously treated BM with local therapy may either be radiographically stable for ≥ 4 weeks since completion of treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
    (ii) Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI/CT scan performed during screening for this study who also have other sites of disease assessable by RECIST 1.1
    3. Participants with BMs must be neurologically stable and:
    (a) Be receiving the equivalent of dexamethasone ≤ 3 mg/day mg/day if treatment is required
    (b) If receiving an anticonvulsant regimen, the regimen must have been stable for ≥ 14 days before first day of dosing
    (c) Relevant records of any CNS treatment must be available to allow for classification of TLs and NTLs
    4. Previous breast cancer treatment:
    (a) Radiologic or objective evidence of disease progression onon or after HER2 targeted therapies.
    Note: Disease progression within 6 months after adjuvant treatment with HER2 targeted therapies is also acceptable.
    (b) No more than 2 lines/regimens of therapy in the metastatic setting.
    Note: A line/regimen of treatment should be counted based on a progression event.
    E.4Principal exclusion criteria
    1. Known or suspected LMD
    2. Prior exposure to tucatinib treatment
    3. Based on screening contrast brain MRI/ CT scan, participants must not have any of the following:
    (a) Any untreated brain lesions > 2.0 cm in size
    (b) Ongoing use of systemic corticosteroids for control of symptoms of BMs at a total daily dose of > 3 mg of dexamethasone (or equivalent).
    (c) Any brain lesion thought to require immediate local therapy,
    (d) Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to BMs notwithstanding CNS-directed therapy
    4. Has spinal cord compression
    E.5 End points
    E.5.1Primary end point(s)
    Participants without BM at baseline (Cohort 1):
    ORR by RECIST 1.1 per ICR
    Participants with BM at baseline (Cohort 2):
    PFS by RECIST 1.1 per ICR
    E.5.1.1Timepoint(s) of evaluation of this end point
    - assessed until progression or death
    E.5.2Secondary end point(s)
    1. Participants in both cohorts:
     - OS
     - DoR by RECIST per ICR
     - Time to progression by RECIST per ICR
     - DoT on subsequent lines of therapy
     - PFS2
    Participants without BM at baseline (Cohort 1):
     - Incidence of new symptomatic CNS metastasis during treatment

    In patients who develop isolated CNS progression, receive local therapy, and continue on protocol therapy:
     - Time to next progression (CNS or extracranial) or death
     - Site (CNS vs extracranial vs both) of next progression

    2. Participants with BM at baseline (Cohort 2):
     - ORR by RECIST 1.1 per ICR
     - CNS PFS by CNS RECIST 1.1 per ICR
     - Time to new CNS lesions
     - CNS ORR by CNS RECIST 1.1 per ICR
     - CNS DoR by CNS RECIST 1.1 per ICR

    3. Changes in symptoms, functioning, and HRQoL as measured by
     - All patients: EORTC QLQ-C30, NANO scale, cognitive tests
     - BM patients: MDASI brain tumor-specific items
     - ILD/pneumonitis patients: SGRQ-I

    4. Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical laboratory results, and ECGs.
    Assessments related to AEs will also include:
     - Rate of investigator-assessed ILD/pneumonitis
     - Rate of AEs among patients with baseline BM who are treated with concurrent high-dose
    steroid (total daily dose > 2 mg dexamethasone or equivalent)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints for key secondary endpoints are: please see section secondary endpoints for corresponding timepoints below
    - assessed until progression or death
    - AEs and SAEs throughout the treatment period and including the safety follow-up (40+ up to 7 days after discontinuation of all study interventions)
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E. trial design description
    2 cohorts
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Russian Federation
    United Kingdom
    United States
    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
    Completing the last expected visit/contact of the last patient undergoing the study.
    He/she has completed all phases of the study as per SoAs (including follow-up for OS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days25
    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: 100
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 333
    F.4.2.2In the whole clinical trial 500
    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)
    After final DCO for this study, AZ will continue to supply T-DXd to participants who received T-DXd until meeting any discontinuation criteria as defined in Protocol. Where possible, if commercial T-DXd is available in local market then this route should be used. In the event that a roll-over or safety extension study is available at time of final DCO and DB closure, participants currently receiving T-DXd treatment may be transitioned to such a study and would be asked to sign a new ICF.
    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 Decision2021-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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