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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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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    Summary
    EudraCT Number:2014-005126-35
    Sponsor's Protocol Code Number:GBG86-DESIREE
    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:2015-03-05
    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 number2014-005126-35
    A.3Full title of the trial
    A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer
    DESIREE - Eine multizentrische, randomisierte doppelblinde, Phase-II-Studie zum Vergleich der Verträglichkeit bei einschleichender Dosierung von Everolimus bei Patientinnen mit metastasiertem Brustkrebs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This multicenter, randomized, double-blind, phase II study aims to show improvement in the rate of mucositis/stomatitis (WHO´s OTS) grade 2-4 at 12 weeks after start of treatment by comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema starting with a low dose over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    DESIREE
    A.4.1Sponsor's protocol code numberGBG86-DESIREE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02387099
    A.5.4Other Identifiers
    Name:NovartisNumber:CRAD001JDE60T
    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 SponsorGBG Forschungs GmbH
    B.1.3.4CountryGermany
    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 supportGBG Forschungs GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGBG Forschungs GmbH
    B.5.2Functional name of contact pointClinical Trials Information Desiree
    B.5.3 Address:
    B.5.3.1Street AddressMartin Behaim Str 12
    B.5.3.2Town/ cityNeu-Isenburg
    B.5.3.3Post code63263
    B.5.3.4CountryGermany
    B.5.4Telephone number+4961027480337
    B.5.5Fax number+4961027480440
    B.5.6E-maildesiree@germanbreastgroup.de
    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 Afinitor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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 nameAfinitor
    D.3.2Product code RAD001
    D.3.4Pharmaceutical form 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 INNEVEROLIMUS
    D.3.9.1CAS number 159351-69-6
    D.3.9.2Current sponsor codeRAD001
    D.3.9.4EV Substance CodeSUB02065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboTablet
    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
    Advance Breast cancer under endocrine treatment
    Fortgeschrittener Brustkrebs unter endokriner Behandlung
    E.1.1.1Medical condition in easily understood language
    Advance Breast cancer under endocrine treatment
    Fortgeschrittener Brustkrebs unter endokriner Behandlung
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072740
    E.1.2Term Locally advanced breast cancer
    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 compare the cumulative rate of mucositis/stomatitis grade 2-4 (WHO’s oral toxicity scale (OTS)) at 12 weeks after start of treatment using a conventional and a dose-escalating schema of everolimus in combination with exemestane in patients with metastatic breast cancer and progression or relapse after non-steroidal aromatase-inhibitor treatment.
    Vergleich der kumulativen Rate von Mukositis Grad 2-4 (WHO Skala OTS), 12 Wochen nach Beginn der Behandlung jeweils mit dem Standardschema oder einer eskalierenden Dosierung von Everolimus in Kombination mit Exemestan bei Patienten mit metastasierendem Brustkrebs und Progress oder Rezidiv nach nicht-steroidalen Aromatase--Inhibitor Behandlung.
    E.2.2Secondary objectives of the trial
    • To compare the rate of patients on 10mg daily at 12 weeks and 24 weeks after start of everolimus treatment
    • To compare the clinical benefit rate (CR, PR und SD >=16 Weeks) at 24 weeks after start of everolimus treatment
    • To compare the safety with regard to other organ signs and symptoms
    • To compare the time to grade ≥2 mucositis/stomatitis
    • To compare the cumulative dose at 4 weeks
    • To compare the relative dose intensity for everolimus
    • To compare quality of life using the FACT-B questionnaire and the QSDQ
    • Potential biomarkers predicting safety and compliance will be determined after completion of study treatment
    Sekundäre Studienziele
    • Vergleich der Rate an Mucositis/ Stomatitis zwischen den Behandlungsarmen bei 12 und 24 Wochen nach Behandlungsbeginn mit Everolimus
    • Vergleich des klinischen Benefits (CR, PR und SD >=16 Wochen) zwischen den Behandlungsarmen nach mindestens 24 Wochen Everolimustherapie
    • Ermittlung der Sicherheit hinsichtlich anderer Gesundheitsparameter und Symptome
    • Vergleich der Zeiten bis zum Auftreten ein Mucositis >= 2
    • Vergleich der kumulativen Dosis nach 4 Wochen
    • Vergleich der relativen Dosisintensität von Everolimus
    • Vergleich der Lebensqualität anhand des FACT-B Fragebogens und des QSDQ
    • Vergleich der Dauer des Ansprechens zwischen den Behandlungsarmen
    Potentielle prädiktive Biomarker hinsichtlich Verträglichkeit und Patientenkooperation werden nach Abschluss der Behandlung und der Studie festgelegt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Locally advanced or metastatic stage of disease not amenable to curative treatment by surgery or radiotherapy alone.
    - No indication for chemotherapy (e.g. symptomatic visceral metastasis)
    -Histological confirmed hormone receptor-positive (HR+), HER2-negative carcinoma of the breast.
    - Postmenopausal women
    - Disease progression following prior therapy with non steroidal aromatase inhibitors (NSAI), defined as:
    a. Recurrence while on, or following completion of an adjuvant treatment with Letrozole or Anastrozole, or
    b. Progression while on or following completion of Letrozole or Anastrozole treatment for ABC/MBC.
    Note: Non-steroidal aromatase inhibitors (i.e. Letrozole or Anastrozole) do not have to be the last treatment prior to enrollment. Other prior anticancer therapy, e.g. Tamoxifen, Fulvestrant, Exemestane, is also allowed. Patients must have
    recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.
    - At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation field or there must be pathologic proof of newly progressive disease.
    E.4Principal exclusion criteria
    - Concurrent immunotherapy or hormonal therapy (contraceptive and/or replacement therapy). Bisphosphonates or denosumab may be continued or started before randomization.
    - Life expectancy of less than 3 months.
    - Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy.
    -Any ongoing toxicity from prior anti-cancer therapy that is grade 3-4 and/or that is progressing in severity, except alopecia or anemia controlled by growth factors.
    -Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease, angina pectoris requiring anti-anginal medication, previous history of myocardial infarction ≤ 6months, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
    - Currently active infection.
    -History of other malignancies within the last 5 years which significantly affect the diagnosis, assessment or prognosis of metastatic breast cancer.
    -Malabsorption syndrome or insufficient gastrointestinal function, preexisting diagnosis of ulcerative colitis.
    -Concurrent treatment with other experimental drugs; participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
    -Insufficiently controlled diabetes, known HIV infection or chronic hepatitis B or C and seriously impaired liver function (Child-Pugh, class A, B or C).
    E.5 End points
    E.5.1Primary end point(s)
    First episode of mucositis WHO’s OTS 2-4
    E.5.1.1Timepoint(s) of evaluation of this end point
    any time during a 12 week period after start of everolimus
    E.5.2Secondary end point(s)
    Average dose of treatment during week 12 and during week 24.
    Clinical benefit rate (CBR) is defined as all patients with no evidence for tumor progression at 24 weeks after start of everolimus treatment.
    Safety by toxicity grades in general is defined by the NCI-CTCAE version 4.03, mucositis by WHO’s OTS. Cumulative dose will be calculated by adding all daily doses of everolimus until end of treatment or discontinuation.
    Relative dose intensity for everolimus is the ratio of Actual Total Dose Intensity (ATDI) and Planned Total Dose Intensity (PTDI), expressed as a percentage.
    Quality of life will be assessed using the FACT-B questionnaire and the QSDQ.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12 and week 24
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient Related Outcomes FACT-B and QSQD questionnaire
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned60
    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
    LVLS
    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 months4
    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: 156
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    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 No
    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 state156
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 156
    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 treated according to the usual standard of care for that condition. Investigators may judge to continue treatment with examestan/afinitor.
    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 Decision2015-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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