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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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:2006-002529-21
    Sponsor's Protocol Code Number:MO19391
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-01
    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 ConcernedGermany - PEI
    A.2EudraCT number2006-002529-21
    A.3Full title of the trial
    Open-label study of bevacizumab (Avastin®) plus taxane monotherapy or in combination for the first-line treatment of patients with locally recurrent or metastatic breast cancer
    A.3.2Name or abbreviated title of the trial where available
    ATHENA
    A.4.1Sponsor's protocol code numberMO19391
    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 SponsorF.Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameAvastin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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, VEGT, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanised 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
    Locally recurrent or metastatic breast cancer
    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 is to assess the safety profile of bevacizumab when combined with taxane monotherapy or in combination as first line treatment of patients with locally recurrent (LR) or metastatic breast cancer (mBC).
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of bevacizumab when combined with taxane monotherapy or in combination as first line treatment of patients with LR or mBC as measured by time to disease progression (TTP) and overall survival (OS).

    - To assess the safety of bevacizumab in patients who develop CNS metastases during and for 6 months following the treatment period.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluation of biomarkers and VEGF-A constitutional polymorphisms in the context of the main ATHENA study. (15-08-2007)
    E.3Principal inclusion criteria
    1. Written informed consent (informed consent document to be approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure

    2. Age ≥18 years

    3. Able to comply with the protocol

    4. Histologically or cytologically confirmed, HER2-negative, pre- or post-menopausal women with adenocarcinoma of the breast with measurable or non-measurable LR or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
    - HER2-positive patients are eligible if they have progressed after previous trastuzumab (Herceptin®) treatment in the adjuvant setting and are not eligible for any specific anti HER2+ve treatment. Concomitant use of bevacizumab and trastuzumab is not allowed

    5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

    6. Life expectancy of ≥12 weeks

    7. Prior adjuvant chemotherapy is allowed

    8. Prior radiation therapy is allowed if:
    - delivered in the adjuvant setting as a part of the treatment of early breast cancer and provided that the patient has completely recovered from all acute radiotherapy related toxicity (with exception of alopecia)
    - delivered prior to study entry for the relief of metastatic bone pain, provided that no more than 30% of marrow-bearing bone has been irradiated (if using chemotherapy backbone which is highly myelosuppressive) and provided that the patient has completely recovered from all acute radiotherapy related toxicity (with exception of alopecia)

    9. Adequate haematological function
    - Absolute neutrophil count (ANC) ≥1.5 x 10[9]/L AND
    - Platelet count ≥100 x 10[9]/L AND
    - Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)

    10. Adequate liver function
    - Total bilirubin <1.5 x upper limit of normal (ULN) AND
    - AST, ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases

    11. Adequate renal function
    - Serum creatinine ≤1.25 x ULN or calculated creatinine clearance ≥50 mL/min AND
    - Urine dipstick for 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 in 24 hours

    12. International normalized ratio (INR) ≤1.5 and PTT ≤1.5 x ULN within 7 days prior to enrolment

    13. If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
    E.4Principal exclusion criteria
    1. Previous chemotherapy for LR or mBC

    2. Concomitant hormonal therapy with bevacizumab for LR or metastatic disease, however previous hormonal therapy is allowed for adjuvant, LR, or mBC

    3. Patients must have received no radiation therapy for the treatment of metastatic disease (apart from those who received it for the relief of metastatic bone pain and with the precautions mentioned above)

    4. Evidence of CNS metastases (even if previously treated). If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases

    5. Pre-existing peripheral neuropathy NCI CTC-AE Grade >2 at enrolment

    6. Major surgery (including open biopsy), significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during study treatment

    7. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion

    8. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (>325 mg/day)

    9. Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed

    10. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding

    11. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)

    12. Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication

    13. Non-healing wound, active peptic ulcer or bone fracture

    14. History of abdominal fistula, diagnosed with a tracheo-oesophageal fistula or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment

    15. Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception (oral contraceptive in case not contraindicated for use with concomitant chemotherapy backbone treatment, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of bevacizumab.

    16. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of bevacizumab

    17. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment

    18. Known hypersensitivity to bevacizumab and any of its excipients, and any of the chemotherapies

    19. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

    20. History of thrombotic disorders within the last 6 months prior to enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of SAEs related to bevacizumab and the incidence of specific AEs (serious and non-serious) such as hypertension, proteinuria, arterial and venous thromboembolism, CHF, CNS bleeding, other haemorrhages, wound-healing complications, and gastrointestinal perforations, are considered as primary endpoints. Patients with ECOG PS 2 will be analyzed separately.
    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 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) 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 No
    E.8.1.2Open Yes
    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 concerned52
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA277
    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 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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 2006-08-01. Yes
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1520
    F.4.2.2In the whole clinical trial 2291
    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 Decision2006-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-02
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