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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2005-005186-10
    Sponsor's Protocol Code Number:EGF105485
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-23
    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 ConcernedLatvia - SAM
    A.2EudraCT number2005-005186-10
    A.3Full title of the trial
    A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib in Women with Early-Stage ErbB2 Overexpressing Breast Cancer
    A.4.1Sponsor's protocol code numberEGF105485
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameLapatinib
    D.3.2Product code GW572016
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLapatinib
    D.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    D.3.9.3Other descriptive nameLapatinib ditosylate monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Women with early-stage ErbB2-overexpressing breast cancer. Eligible women must have had an initial diagnosis of histologically or cytologically confirmed invasive breast cancer (Stage I through Stage IIIb) with ErbB2 overexpression defined as 3+ by immunohistochemisty (IHC) or c-erbB2 gene amplification by fluorescence in-situ hybridization (FISH).
    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 objective for this study is to evaluate and compare disease-free survival (DFS) in women treated with lapatinib versus placebo.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate and compare between treatment arms the following: overall survival, recurrence-free intervals [local, regional, distant, and central nervous system (CNS)], rate of CNS recurrence, toxicity, and quality of life.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    •Histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma (Tx or T1-4) of the breast at initial diagnosis and undergone adequate excision of tumour;
    •Women with synchronous bilateral invasive breast cancer or synchronous DCIS of either the contralateral or ipsilateral breast at the time of the initial diagnosis are also eligible; prior endocrine therapy as treatment for or as primary prevention of DCIS is allowed.
    •Completed all primary adjuvant chemotherapy regimens prior to study enrolment. However, adjuvant endocrine therapy and radiotherapy may continue. For women who received an anthracycline-based adjuvant regimen, the interval between the completion of this therapy and study entry must be at least 4 weeks and all therapy-related toxicity must be resolved.
    •Women who have not received trastuzumab in the adjuvant setting, but are eligible for such treatment, are allowed to participate in this study provided the physician and patient have considered the treatment and decided not to initiate therapy with trastuzumab, for practical reasons. Clear documentation of such decision must appear in the Electronic Case Report Form (eCRF);
    •Have clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry:
    •Must have had an analysis of both ER and progesterone receptor (PgR) on the primary tumour prior to study entry;
    •Have undergone either total mastectomy OR lumpectomy;
    •Must have received a prior adjuvant chemotherapy regimen containing either an anthracycline or a taxane; or any cyclophosphamide, methotrexate and 5-fluorouracil (CMF) regimen;
    •May continue to receive endocrine therapy, including tamoxifen or an aromatase inhibitor, while taking study medication, if endocrine therapy was initiated as either adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer or for ovarian function suppression;
    •May have received prior radiotherapy as treatment for primary tumour.
    •May continue to receive radiotherapy while taking study medication, if radiotherapy was initiated as adjuvant therapy for treatment of the initial diagnosis of invasive breast cancer;
    •May continue to receive bisphosphonates only for treatment of documented osteoporosis, but not as treatment or prophylaxis of bone metastases;
    •Have not received prior therapy with an ErbB1 and/or ErbB2 inhibitor;
    •Have a cardiac ejection fraction within institutional range of normal measured by either ECHO or MUGA scans.
    •Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 .
    •Women with a history of non-breast malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Women with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin;
    •Are able to swallow and retain oral medication;
    •Have an archived tumour tissue samples available for biomarker analysis.
    •Able to complete all screening assessments as outlined in the protocol;
    •Have adequate organ function
    •Have signed the informed consent form (ICF);
    •Are aged >= 18 years with any menopausal status;
    •Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are post- menopausal);
    •Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:
    - Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or
    - Consistent and correct use of one of the following acceptable methods of birth control:
    - male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject;
    - implants of levonorgestrel;
    - injectable progestogen;
    - any intrauterine device with a documented failure rate of less than 1% per year;
    - oral contraceptives (progestogen only); or barrier methods, including diaphragm or condom with a spermicide
    E.4Principal exclusion criteria
    Women will not be eligible for inclusion in this study if any of the following criteria apply:
    1.Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry;
    2.Had metachronous invasive breast cancer (breast cancers diagnosed at different times);
    3.Have a prior history of other breast cancer malignancies, including DCIS;
    4.Are unable to provide archived tumor tissue samples for assay;
    5.Had prior therapy with an ErbB1 and/or ErbB2 inhibitor;
    6.Receive concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication;
    7.Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
    8.Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded;
    9.Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety;
    10.Have an active or uncontrolled infection;
    11.Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
    12.Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
    13.Are pregnant or breastfeeding;
    14.Receive concurrent treatment with an investigational agent or participate in another clinical trial;
    15.Receive concurrent treatment with prohibited medications (refer to Section 8.2 for details on prohibited medications);
    16.Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
    17.Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients;
    18.In France, subjects are neither affiliated with nor a beneficiary of a social security category.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for analysis is disease-free survival (DFS) which includes the following events:
    •local recurrence following mastectomy
    •local recurrence in ipsilateral breast following lumpectomy
    •regional recurrence
    •distant recurrence
    •contralateral breast cancer, including ductal carcinoma in situ (DCIS)
    •other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast)
    •death from any cause without prior event (recurrence of breast cancer or second primary cancer)
    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 No
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other 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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    A subject will be considered as completing the study for data collection purposes to ensure adequate collection of survival information if:
    •the subject is no longer receiving treatment with investigational product and has completed 10 years of follow-up;
    OR
    •the subject has died.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    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 years13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 2006-08-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1750
    F.4.2.2In the whole clinical trial 3000
    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)
    Normal standard of care
    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 Decision2006-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
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