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    Summary
    EudraCT Number:2011-003530-13
    Sponsor's Protocol Code Number:18072011
    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:2011-11-18
    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 number2011-003530-13
    A.3Full title of the trial
    Randomised phase II window study of short-term preoperative treatment with the PI3K inhibitor GDC-0941 plus Anastrozole versus Anastrozole alone in patients with ER-positive primary breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the novel cancer drug GDC-0941 in combination with the approved anticancer drug anastrozole compared to anastrozole alone given to patients with early breast cancer before undergoing operation.
    A.3.2Name or abbreviated title of the trial where available
    OPPORTUNE
    A.4.1Sponsor's protocol code number18072011
    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 SponsorBrighton & Sussex University Hospitals NHS Trust
    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 supportGenentech Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBrighton & Sussex University Hospitals NHS Trust
    B.5.2Functional name of contact pointTrial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressCIRU, Level 5, The Royal Sussex County Hospital, Eastern Rd
    B.5.3.2Town/ cityBrighton
    B.5.3.3Post codeBN2 5BE
    B.5.4Telephone number01273696955
    B.5.5Fax number01273664855
    B.5.6E-mailgemma.sugar@bsuh.nhs.uk
    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 nameGDC-0941
    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 INNGDC-0941
    D.3.9.1CAS number 957054-33-0
    D.3.9.2Current sponsor codeGDC-0941
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number260
    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 RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Arimidex
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAnastrozole
    D.3.4Pharmaceutical form Tablet
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary breast cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the breast
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006206
    E.1.2Term Breast carcinoma NOS
    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
    In women with ER-positive breast cancer about to undergo surgery, does two week's pretreatment with a new drug (the PI3K inhibitor GDC-0941, given in combination with the estrogen-blocker anastrozole) increase the benefits of anastrozole in slowing down tumour cell growth, as measured by laboratory measurements on tumour cells?
    E.2.2Secondary objectives of the trial
    • Does the new combination kill cancer cells more effectively than anastrozole alone?

    • Is the new combination more effective than anastrozole alone in shrinking the breast cancer?

    • Is it possible to link any apparent benefits of using GDC-0941 to the biomarker status of the patient, perhaps leading to a strategy of tailored drug therapy to be examined in future studies?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women must meet ALL of the following criteria:

    • Histologically-confirmed breast cancer involving a palpable tumour of any size, or a tumour with an ultrasound-assessed diameter of ≥ 1.0 cm

    • Estrogen receptor (ER) positive tumours with ≥1% of tumour cells positive for ER on immunohistochemical staining or an immunhistochemistry score (Allred) of 3 or higher

    • *No prior systemic treatment regimens for the new primary breast cancer currently under investigation; prior treatment for previous breast cancer is allowed as long as it was completed at least 1 year prior to inclusion into this trial.*
    • Postmenopausal, defined as
    1) age ≥ 55y and 1y or more of amenorrhea, OR
    2) age < 55y and 1y or more of amenorrhea, with an estradiol assay <20 pg/mL, OR
    3) age < 55y with prior hysterectomy but intact ovaries with an estradiol level <20 pg/mL, OR
    4) Status after bilateral oophorectomy (≥ 28 days prior to first study treatment).

    • Adequate hematologic function (ANC ≥ 1500 cells/µl + platelet count ≥ 100000/µl).

    • Serum creatinine concentration < 1.5 x ULN; AST, ALT, bilirubin level < 1.5 x ULN; Fasting plasma glucose level < 7.8 mmol/L.

    • ECOG performance status 0-2

    • Written informed consent prior to admission to the study
    E.4Principal exclusion criteria
    • Male gender
    • *Inflammatory breast cancer.*
    • HER2-positive tumours with 3+ intensity on IHC staining for HER2 or amplification of the HER2 gene on ISH.
    • Evidence of distant metastases.
    • *Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments); prior treatment for previous breast cancer is allowed as long as it was completed at least 1 year prior to inclusion into this trial.*
    •*Previous systemic treatment for other neoplasms within 1 year prior to inclusion into this trial.*
    • Clinically significant pulmonary dysfunction.
    • Uncontrolled Type 1 or 2 diabetes mellitus (diabetic patients must have been on a stable regimen of oral anti-hyperglycemic therapy for at least 3 weeks duration and must have home monitoring levels without fasting blood glucose >8.9 mmol/L or hypoglycemia for one week prior to study entry)
    • Serious intercurrent medical or psychiatric illness, including serious active infection.
    • Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry.
    • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
    E.5 End points
    E.5.1Primary end point(s)
    Change in tumour cell proliferation measured by Ki67 immunohistochemical assessment (%) in biopsy samples taken at diagnosis and day 15.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and on day 15.
    E.5.2Secondary end point(s)
    The secondary outcome measures for this study are:
    • Increase in apoptosis: Changes in the tumour (TUNEL assay) measured at diagnosis and on day 15.
    • Change in tumour cell proliferation after discontinuation of GDC-0941 as measured by Ki67 IHC (%) on day 15 and on the day of definitive surgery *(if surgery is not performed on Day 15 +/- 2 days*)
    • Clinical objective response.
    • Pathological response and residual cancer burden.

    The safety outcome measures for this study are as follows:
    • Incidence of serious adverse events
    • Incidence of all adverse events of all grades
    • Adverse events leading to anastrozole or GDC-0941 discontinuation
    • Changes in vital signs and clinical laboratory results during and following study drug administration
    • Changes in ECG measurements

    Exploratory Outcome Measures
    Exploratory outcome measures may include genome-wide measurements in tumour DNA and RNA, including mutational status, RNA gene-expression values, DNA copy number, and protein expression and phosphorylation. Exploratory analysis may include, but will not be limited to, the following:
    • Presence of activating PI3KCA mutations in tumour specimens taken at surgery by PCR and/or sequencing
    • Level of PTEN expression in tumour biopsy specimens taken at baseline, after 15 (+/-2) days of treatment and at surgery by IHC and/or reverse phase protein array (RPPA)
    • Level of expression and phosphorylation of candidate proteins (including but not limited to Akt, PTEN, S6, p70S6, PRAS40, EGFR, HER2, HER3, ERK1/2, GSK3ab, ER, MEK1-2, p27, 4EBP1) in tumour biopsy specimens taken at baseline, after 15 (+/-2) days of treatment and at surgery by IHC, reverse-phase protein arrays and/or coincidence detection assay
    • Gene copy number of PTEN and other candidate genes in tumour specimens taken at surgery
    • Presence of activating PI3KCA mutations from plasma DNA
    • Presence of PI3K/PTEN-regulated gene expression signature in tumour biopsy specimens taken at baseline, after 15 days (+/-2 days) of treatment and at surgery by gene expression microarrays or Fluidigm Microfluid Platform
    • Presence of Luminal A and Luminal B breast cancer markers through transcriptional profiling
    • Molecular profiling of tumour biopsy specimens taken at baseline, after 15 (+/-2) days of treatment and at surgery including mRNA (e.g. by microarrays), microRNA (e.g. by microarrays or PCR), protein expression/phosporylation (e.g. mass spectroscopy), re-sequencing, and promoter methylation (e.g. by methylation microarrays and Pyrosequencing)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, on day 15 and at surgery *(if surgery is not performed on Day 15 +/- 2 days)*
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned4
    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
    30 days after the last patient receives the last dose of the investigational medicinal product (IMP).
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.1Number 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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state141
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 141
    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)
    For GDC-9041: treatment stops before surgery and would not be continued after surgery.

    For anastrozole: in both treatment groups it is likely that anastrozole would be prescribed after surgery as part of usual care. This decision will be at the discretion of the clinical care team and will not be influenced by participation in this study.
    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 Decision2011-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-09
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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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