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    Summary
    EudraCT Number:2011-002157-64
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-002157-64
    A.3Full title of the trial
    ARomatase Inhibition plus minus SaracaTinib as Advanced breast CAncer Therapy: a randomised phase II study of aromatase inhibition plus/minus the src-inhibitor AZD0530 in post-menopausal women with advanced breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised phase II double blind (neither patient or doctor know which treatment they are taking) trial looking to see if giving patients saracatinib in addition to usual aromatase inhibitors will prevent or delay disease resistance in post menopausal women with advanced breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    ARomatase Inhibition +- SaracaTinib as Advanced breast CAncer Therapy
    A.4.1Sponsor's protocol code number
    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 SponsorCommon Services Agency
    B.1.3.4CountryUnited Kingdom
    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 supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS National Service Scotland
    B.5.2Functional name of contact pointEve Macdonald
    B.5.3 Address:
    B.5.3.1Street AddressGyle Square, 1 South Gyle Crescent
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH12 9EB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312757058
    B.5.5Fax number01312757512
    B.5.6E-maileve.macdonald@nhs.net
    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 nameSaracatinib
    D.3.2Product code AZD0530
    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 INNSaracatinib
    D.3.9.2Current sponsor codeAZD0530
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 mg tablets & to 125 mg tablets
    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 placeboFilm-coated tablet
    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
    Advanced breast cancer
    E.1.1.1Medical condition in easily understood language
    Breast cancer that has spread and/or come back (relapsed) and is essentially incurable
    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
    The primary research objective is to see whether patients taking an aromatase inhibitor in combination with saracatinib have a longer progression free survival (surving without their cancer growing or spreading) than the patients who are taking aromatase inhibitor with placebo.
    E.2.2Secondary objectives of the trial
    Secondary objectives are: - To see if there are more side effects from taking an aromatase inhibitor and saracatinib compared to taking an aromatase inhibitor alone and to see how severe any side effects are. - To compare overall survival length for both sets of patients. - To test how well tumours shrink/respond to drug treatment, using regular scans/images of the cancer.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Bone sub-study (in all patients): analysis of the effects of saracatinib on markers of bone turnover by comparing the changes during treatment of markers of bone synthesis and resorption. Tumour sub-study (optional for patients with accessible tumours): paired biopsies of before and after 6 weeks' therapy in order to better understand the changes in tumour biology that occur with the addition of saracatinib. Paraffin embedded and fresh frozen samples as available will be used - analyses will be restricted to tumour biology
    E.3Principal inclusion criteria
    1. Clearly post menopausal women with ER positive (Allred score ≥ 3) advanced breast cancer which is measurable. 2. Patients must be performance status 0 – 2. 3. Suitable for treatment with an aromatase inhibitor. 4. Life expectancy > 3 months. 5. Cancer must be HER2- (by FISH and/or IHC as appropriate), OR if the cancer is HER2+ the patient must not be a candidate for ant-HER2 therapy. 6. All patients will need to also meet inclusion criteria for one of the two main strata (noting that entry of patients in sratum (b) is limited to those who DON'T qualify for strata (a): a. “AI-sensitive/naive” group – either never previously treated with an aromatase inhibitor, but if treated with tamoxifen must not have rapid progression on tamoxifen (i.e. treated for at least 24 months adjuvant or ≥ 6 months in metastatic setting); or, if previously treated with an AI, only in the adjuvant or neo-adjuvant setting AND have remained free of progression for at least 12 months whilst not being treated with an AI. b. “prior AI” group – previously treated with a non-steroidal AI without progression for at least 24 months in the (neo-) adjuvant setting or for at least 6 months for advanced disease. 7. Patients who have had two lines of prior AI therapy will not be eligible UNLESS they were switched from one AI to another ONLY for reasons of toxicity, and ONLY during (neo-) adjuvant therapy AND in the absence of any evidence of progression/relapse. 8. Single site of bone disease must be histologically confirmed and known not to be ER negative. 9. Palliative radiotherapy can be given to bone lesions within 4 weeks of trial entry provided not more than 20% of the bone marrow is irradiated, AND there is at least one other measurable bone lesion which has clearly progressed since any prior irradiation. 10. Haematology – commensurate with a phase II hormonal therapy study: Neutrophils > 1.5 * 109/l, Hb> 10.0 g/dl and Platelets > 100 * 109/l 11. Biochemistry – similar: albumin normal, ALT/AST < 2.5 ULN, Alk Phos < 5 * ULN unless of bone origin, e-GFR > 50ml/min. Normal urea & electrolytes. 12. Patients receiving bisphosphonates are eligible, provided they are commenced before, or at, trial entry. Patients will be stratified by use of, or stated intention to give, bisphosphonate at randomisation. Some patients will already be on bisphosphonates, but eg for those newly diagnosed with bone metastases, first administration of the bisphosphonate is encouraged to be given prior to entry (but after baseline blood and urine), but in any case, must be started no less than 1 week AFTER first study medication.
    E.4Principal exclusion criteria
    1. Patients with short life expectancy or significant other co-morbidity including pulmonary fibrosis will be excluded 2. Rapidly progressive visceral disease (lymphangitis, diffuse liver disease, uncontrolled CNS disease). 3. Any evidence of severe or uncontrolled systemic conditions (e.g. interstitial lung disease [bilateral, diffuse, parenchymal change]) 4. Life expectancy < 3 months. 5. Contra-indication to either AZD0530 (or excipients) or aromatase inhibition. 6. Concomitant chemotherapy or anti-HER2 therapy. 7. Measured QTc > 480ms.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of progression free survival between cohort receiving aromatase inhibition plus saracatinib, versus those receiving aromatase inhibition plus placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 110 progression events have occured and at least 6 months after last patient has enrolled (whichever is the later of these two circumstances)
    E.5.2Secondary end point(s)
    Toxicity, tumour shrinkage and overall survival. Translational sub-studies also planned.
    E.5.2.1Timepoint(s) of evaluation of this end point
    secondary end-points with the primary, except for overall survival which will be analysed using data up to 31st March 2017, and the translational ones the timing of which will depend on when the lab studies are complete
    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 Yes
    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 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 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 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 concerned20
    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 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
    The end of the trial will be whichever is sooner of when the last patient has completed their last follow up visit or 31st March 2017 after which point all patients can no longer receive the placebo/saracatinib.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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 who progress or come off study for any other reason, as well as any patient still on study therapy as of 31st March 2017, will return to standardard therapy in the NHS. For some patients who have endocrine sensitive disease this will be continued/ further endocrine therapy: for others whose cancer has progressed on endocrine therapy and is felt to be no longer sensitive, clinicians will discuss the risks and benefits of chemotherapy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-30
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