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    Summary
    EudraCT Number:2010-019965-27
    Sponsor's Protocol Code Number:SAKK21/08
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-019965-27
    A.3Full title of the trial
    Fulvestrant with or without AZD6244, a mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor, in advanced stage breast cancer progressing after aromatase inhibitor: a randomized placebo-controlled double-blind phase II trial.
    Fulvestrant avec ou sans AZD6244 dans le traitement du cancer du sein progressant après une hormonothérapie par inhibiteur de l’aromatase.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fulvestrant with or without a new compound (AZD6244) in advanced stage breast cancer progressing after aromatase inhibitor.
    Fulvestrant avec ou sans un nouvaeu composé (AZD6244) dans le traitement du cancer du sein progressant après une hormonothérapie par inhibiteur de l’aromatase.
    A.3.2Name or abbreviated title of the trial where available
    Fulvestrant with or without AZD6244 in ABC
    A.4.1Sponsor's protocol code numberSAKK21/08
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01160718
    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 SponsorSwiss Group for Clinical Cancer Research
    B.1.3.4CountrySwitzerland
    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 supportAstra Zeneca AG
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportSwiss Group for Clinical Cancer Research
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSwiss Group for Clinical Cancer Research
    B.5.2Functional name of contact pointHead Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4131389 91 91
    B.5.5Fax number+4131389 92 00
    B.5.6E-mailsakkcc@sakk.ch
    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 Faslodex
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK 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 nameFulvestrant
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFULVESTRANT
    D.3.9.1CAS number 129453-61-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 2
    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 nameAZD6244
    D.3.2Product code AZD6244
    D.3.4Pharmaceutical form Capsule
    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 INNSelumetinib
    D.3.9.3Other descriptive nameAZD6244
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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
    Patient with advanced stage breast cancer (HER2 positive is allowed), i.e. locally advanced or metastatic breast cancer that is not amenable to curative surgery and/or radiation.
    E.1.1.1Medical condition in easily understood language
    Patient with advanced stage breast cancer, i.e. locally advanced or metastatic breast cancer that is not amenable to curative surgery and/or radiation.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term 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
    The primary objective of the trial is to assess the efficacy of the combination AZD6244-fulvestrant in patients with endocrine sensitive breast cancer progressing after aromatase inhibitors.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the safety/tolerability of the combination AZD6244-fulvestrant, and other outcome parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient must give written informed consent before any trial-specific examination and randomization.
    - Histologically/cytologically confirmed diagnosis of breast cancer.
    - Advanced stage breast cancer (HER2 positive is allowed), not amenable to curative therapy.
    - All available biopsies tested are estrogen receptor and/or progesterone receptor positive: ≥10 % tumor cells positive by immunohistochemistry or ≥ 10 fmol/mg cytosol protein by ligand binding assay.
    - Patients with bilateral breast cancer are eligible if tumors endocrine sensitivity has been proven on both sides.
    - Relapse or progression after AI used as adjuvant therapy or for advanced stage disease. Previous treatment with tamoxifen is allowed.
    - ≤ 1 line of chemotherapy for advanced stage breast cancer.
    - Measurable disease (according to RECIST criteria v1.1 [80]) or other lesions assessable by radiological exams, i.e. bone-only disease or small but unequivocal liver or lung metstases [96].
    - Postmenopausal women (FSH, LH, and estradiol must be measured in case of doubt to confirm postmenopausal status)
    - WHO performance status of 0, 1, or 2 (see Appendix 3)
    - Patient is able to swallow AZD6244/placebo capsules
    - Patient has capability to understand information given by the investigator on the trial.
    - Patient adherence and geographic proximity allow proper staging, treatment, and follow-up.
    - Adequate hematological values: hemoglobin level > 90 g/L, platelets ≥ 100 x 109/L, and neutrophils ≥ 1.5 x 109/L.
    - Adequate coagulation tests: INR (International Normalized Ratio) <1.6 and PTT (partial thromboplastin time) in the normal range.
    - Adequate renal function (creatinine clearance > 30mL/min according to Cockcroft-Gault Formula (see Appendix 2)).
    - Adequate hepatic function: ALT ≤ 2.5 x ULN (or ≤ 5 x ULN in patients with liver metastases), bilirubin ≤ 1.5 x ULN.
    E.4Principal exclusion criteria
    - Previous treatment with fulvestrant, AZD6244, MEK inhibitors, RAF inhibitors, or endocrine therapies other than AIs (anastrazole, letrozole, exemestane) and tamoxifen.
    - More than 1 line of AI (steroidal and non steroidal AIs are considered two different lines).
    - 2 or more lines of chemotherapy for advanced disease
    - Concomittant cancer therapy or other experimental drugs.
    - Treatment with other experimental drugs or participation in a clinical trial within 30 days prior to trial entry.
    - Contraindication for intramuscular injections
    - Known central nervous system metastasis (patients with brain metastasis treated with radiotherapy and without any sign of brain progression after > 3 months since the end of the radiotherapy may be considered eligible after trial chair approval)
    - Bleeding diathesis.
    - Full-dose anticoagulation during the trial treatment (see also 6.1.16). (Patients receiving full-dose anti-coagulant therapy with low molecular weight heparin or acenocoumarol, phenprocoumone, or analogues are ineligible. Patients receiving prophylactic doses of anticoagulation or antiplatelet drugs are eligible, but the risk of bleeding following intramuscular injection of fulvestrant is higher and the risk/benefit ratio has to be assessed by the investigator.
    - Current or previous malignancy other than breast cancer within the last 5 years (except: in situ carcinoma of the cervix and basal carcinoma of the skin treated curatively).
    - Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes).
    - Refractory nausea and vomiting, chronic GI disease (e.g. inflammatory bowel disease) or significant bowel resection that preclude adequate absorption.
    - Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with adherence for oral drug intake.
    - Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg, measured repeatedly at more than two visits despite adequate treatment with at least two different antihypertensive drugs).
    - Clinically significant (i.e. active) cardiovascular disease: CVA/stroke or myocardial infarction within 6 months prior to registration, unstable angina, congestive heart failure [New York Heart Association (NYHA) Class ≥ III (see Appendix 4)], serious cardiac arrhythmia or AV-block >1, requiring medication during the trial and which might interfere with regularity of the trial treatment, or not controlled by medication.
    - In the presence of symptoms suggestive of cardiac impairment (i.e. dyspnea, orthopnea, paroxistic nocturne dyspnea and edema), baseline LVEF must be measured. In this case, patients with baseline LVEF < 50% are excluded.
    - Known hypersensitivity to trial drug(s) or hypersensitivity to any other component of the trial drugs.
    E.5 End points
    E.5.1Primary end point(s)
    Disease control defined as the sum of CR + PR + stable disease ≥ 24 weeks, according to RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    · Adverse events evaluated with the NCI-Common Terminology Criteria for Adverse Events
    version 4.0 (NCI-CTCAE v4.0)
    · Overall response (OR = complete response [CR] + partial response [PR])
    · Progression free survival (PFS; time since randomization to disease progression or death)
    · Time to treatment failure (TTF; time since randomization to discontinuation of the trial
    treatment)
    · Duration of response (DOR)
    · Overall survival (time from randomization to death)
    · Translational substudies
    E.5.2.1Timepoint(s) of evaluation of this end point
    during trial conduct and its lifelong follo-up
    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.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 concerned2
    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
    Switzerland
    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
    until Progressive disease
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 89
    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)
    All patients are in a life long follow up after trial termination.
    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 Decision2011-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-15
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