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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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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-003187-44
    Sponsor's Protocol Code Number:UC-0140/1208
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-20
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2012-003187-44
    A.3Full title of the trial
    Randomized, double-blind, multicentric phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving 3 years of adjuvant hormone therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, double-blind, multicentric phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving 3 years of adjuvant hormone therapy
    A.3.2Name or abbreviated title of the trial where available
    PACS 11 - UNIRAD
    A.4.1Sponsor's protocol code numberUC-0140/1208
    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 SponsorUNICANCER
    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 supportPublic program for clinical research
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointJEROME LEMONNIER
    B.5.3 Address:
    B.5.3.1Street Address101 rue de tolbiac
    B.5.3.2Town/ cityParis
    B.5.4Telephone number33171 93 67 02
    B.5.5Fax number33144 23 04 69
    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. name AFINITOR
    D. of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical form Capsule
    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. 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 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 placeboCapsule
    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
    women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving 3 years of adjuvant hormone therapy
    E.1.1.1Medical condition in easily understood language
    women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving 3 years of adjuvant hormone therapy
    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 evaluate the benefit from adding everolimus to standard endocrine treatments after two years of treatment on the disease-free survival (DFS) after randomization.
    E.2.2Secondary objectives of the trial
    1 - efficacy :
    2 - toxicity :
    3 - biology :
    4 –quality of life sub-studies
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biology and Quality of life
    E.3Principal inclusion criteria
    1. Women ≥ 18 years of age,
    2. Histologically proven invasive unilateral or bilateral breast cancer (regardless of the type),
    3. Any T, M0
    4. At least 4 positive lymph nodes if initial surgery, or at least 1 positive lymph node after neo-adjuvant chemotherapy or hormone therapy
    5. ER+ and HER2 negative : Hormone receptor positive is defined as any staining on the primary tumor, HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH negative]
    6. Initial tumor completely resected (surgery could have been done before or after neoadjuvant chemotherapy/hormone therapy)
    7. Having received at least 2 years and 10 months but not more than 3 years and 6 months of adjuvant hormone therapy. Hormone therapy could be either tamoxifen, letrozol, anastrozol or exemestane.
    8. No clinically or radiologically detectable metastases at time of inclusion.
    9. WHO Performance status (ECOG) of 0 or 1.
    10. Adequate hematological function (neutrophil count ≥ 2x109/l, platelet count ≥ 100x 109/l)
    11. Adequate hepatic function: ASAT and ALAT ≤ 2.5 ULN, alkaline phosphatases ≤ 2.5 ULN, total bilirubin ≤ 2 ULN.
    12. Adequate renal function: serum creatinine ≤ 1.5 ULN.
    13. Signed written informed consent.
    E.4Principal exclusion criteria
    1. Any local, regional or metastatic evolution.
    2. Any clinically or radiologically suspect and non-explored damage to the contra lateral breast.
    3. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheral ephitelioma) in the preceding 5 years, including invasive controlateral breast cancer.
    4. Patients already included in another ongoing therapeutic trial involving an experimental drug for which follow-up is required.
    5. Pregnant or breast-feeding patients. Adequate birth control measures should be taken during study treatment phase.
    6. Patients with severely impaired lung function (e.g. Chronic Obstructive Pulmonary Disease, respiratory insufficiency, Interstitial Lung Disease)
    7. Positive serology for HIV infection or hepatitis C.
    8. Chronic carrier of HBV (positive Antigen HbS in the blood)
    9. Patients with chronic infection
    10. Uncontrolled diabetes defined as glycated haemoglobinemia >7%
    11. Uncontrolled hypercholesterolemia (cholesterol >400 mg/dl under adequate therapy).
    12. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study.
    13. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival rate (DFS) after randomization (disease is defined as a local, regional or metastatic relapse, a contralateral breast cancer, or a death of any cause).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Using an inclusion period of 3 years and a minimum follow-up duration of 2 years for the last included patient, (which correspond to 5 years study duration), 286 events would be observed at the time of the final analysis
    E.5.2Secondary end point(s)
    1. Efficacy :
    - Overall survival rate (OS) for the whole population,
    - DFS and OS for ER+ and PR+ subgroup
    - DFS and OS for the remainder ER+/PR – subgroup
    - EFS
    - DMFS
    - Secondary cancer
    2. Toxicity
    - CTC-AE scale version 4.0.
    3. Biotheque
    - IHC Analysis
    4. Quality of life
    - QlQ C30.
    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
    Biology and quality of life
    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) 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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    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
    E.8.9.2In all countries concerned by the trial years10
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-09-20. Yes
    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 state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1984
    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 Decision2012-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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