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    Summary
    EudraCT Number:2010-022520-73
    Sponsor's Protocol Code Number:CT/10.15
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-17
    Trial 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 ConcernedGreece - EOF
    A.2EudraCT number2010-022520-73
    A.3Full title of the trial
    Phase II, open-label non-randomized trial to investigate the efficacy of Bevacizumab in combination with dose dense sequential chemotherapy in the neo-adjuvant setting for HER2 negative breast cancer patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not Available
    A.3.2Name or abbreviated title of the trial where available
    Not Available
    A.4.1Sponsor's protocol code numberCT/10.15
    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 SponsorHellenic Oncology Research Group
    B.1.3.4CountryGreece
    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 supportRoche
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Heraklion Crete
    B.5.2Functional name of contact pointIoannis Athanasakis
    B.5.3 Address:
    B.5.3.1Street AddressStavrakia - Voutes
    B.5.3.2Town/ cityHeraklion Crete
    B.5.3.3Post code71110
    B.5.3.4CountryGreece
    B.5.4Telephone number00302810392783
    B.5.5Fax number00302810543601
    B.5.6E-maildclintrials@gmail.com
    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 Avastin® cs.sol.inf. 25mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAvastin® cs.sol.inf. 25mg/ml
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMAB VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanized monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early breast cancer (primary operable HER2-negative breast cancer)
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    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 preliminary antitumor activity in terms of pathological complete sponses (pCR) of bevacizumab in combination with dose-dense chemotherapy.
    E.2.2Secondary objectives of the trial
    1. To determine the objective clinical response rates (cRR), disease-free interval (DFI), verall survival (OS), and rate of breast conservative surgery (BCS)
    2. To evaluate the safety of this regimen
    3. To explore the correlation of specific angiogenesis biomarkers with the clinical and pathological response of pts to the treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female patients with histologic proven, corebiopsied, invasive ductal adenocarcinoma of the breast >2 cm in size and of any N stage (clinical and/or radiological T-stage > T1, including T4d), scheduled to receive preoperative hemotherapy.
    • Age 18-70 years
    • ECOG performance-status ≤1
    • No prior or current neoplasm except for curatively treated non melanoma skin cancer, in situ carcinoma of the
    cervix
    • No distant disease/secondary carcinoma
    • Normal cardiac function
    • Results of the following assessments at the time of inclusion must be available:
    - bilateral Mammography (before enrolment)
    - histology
    - grading
    - hormone-receptor-status
    - HER2 status negative (is defined as FISH/CISH negative or IHC0 or IHC1+, or IHC2+ and FISH/CISH negative)
    • Laboratory requirements (within 1 week before enrolment):
    (a) Hematology: Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100 x 109/l, Hemoglobin>11 g/dl
    (b) Hepatic function: Total bilirubin < 1 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1.5 x ULN, Alkaline
    phosphatases < 1.5 x ULN. In case of abnormal values, the liver function tests have to be repeated within 3 days before study treatment.
    (c) Renal function: Creatinine < 1 x ULN
    (d) Urinalysis: Urine dipstick of proteinuria < 2+.
    Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24–hour urine collection and must demonstrate <1 g of protein / 24 hours.
    • Signed and dated Informed Consent before the start of specific protocol procedures
    • If of childbearing potential, negative pregnancy test
    E.4Principal exclusion criteria
    • Cytological only confirmation of diagnosis
    • Lobular or other non-ductal types of breast cancer
    • Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation
    • Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC AE Version 3.0
    • Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy)
    • Prior or concurrent systemic antitumor therapy
    • Evidence of wound healing complications, bone fracture, ulcer or the presence of linically significant peripheral vascular disease
    • Clinically significant cardiac disease e.g. congestive heart failure.
    • Other serious illness or medical condition -uncontrolled hypertension or high risk uncontrolled arrythmias -history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent-active uncontrolled infection -unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids
    • Known hypersensitivity reaction to the compounds or incorporated substances.
    • Evidence of bleeding diathesis or coagulopathy
    • The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least
    two weeks at the time of randomization. Patients not receiving anti coagulant medication must have an INR ≤ 1.5 an aPTT ≤ 1.5 x ULN within 7 days of randomization.
    • Ongoing treatment with aspirin (> 325mg / day) or other medications known to predispose to gastrointestinal ulceration.
    • Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment.
    • Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
    • Treatment with an investigational drug within 30 days prior to study entry.
    • Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the preliminary antitumor activity in terms of pathological complete responses (pCR) of bevacizumab in combination with dose-dense
    chemotherapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 months
    E.5.2Secondary end point(s)
    1. To determine the objective clinical response rates (cRR), disease-free interval (DFI), overall survival (OS), and rate of breast conservative surgery (BCS)
    2. To evaluate the safety of this regimen
    3. To explore the correlation of specific angiogenesis biomarkers with the clinical and pathological response of pts to the treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    This information included in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months65
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.1.2Preterm 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) No
    F.1.3Elderly (>=65 years) No
    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 state48
    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)
    According to the clinical practice
    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 Decision2011-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-17
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