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    Summary
    EudraCT Number:2007-001128-11
    Sponsor's Protocol Code Number:BO20289
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-001128-11
    A.3Full title of the trial
    An international multi-centre open-label 2-arm phase III trial of adjuvant bevacizumab in triple negative breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    BEATRICE
    A.4.1Sponsor's protocol code numberBO20289
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorROCHE
    B.1.3.4CountryItaly
    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 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.3.4Pharmaceutical 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 No
    D.IMP: 2
    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 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.3.4Pharmaceutical 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 No
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    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 compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.
    E.2.2Secondary objectives of the trial
    - The secondary objectives of this trial are to compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease-Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab - Identification of a biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment. - To evaluate the Safety and Tolerability of bevacizumab.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patient Specific and General Inclusion Criteria 1. All patients must have signed and dated an informed consent form 2. Patients must be > 18 years old 3. The patient must have an ECOG Performance Status of 0 or 1 Disease Specific Inclusion Criteria 4. The patient must have presented with an operable primary invasive carcinoma of the breast. Patients with multifocal and synchronous bilateral cancers are eligible on the condition that - all cancers (excluding any associated DCIS) are of the triple negative phenotype and - the eligibility is based on the highest stage grouping 5. Definitive loco-regional surgery has been completed a) patients must have undergone either breast conservation surgery (i.e. lumpectomy) or a total mastectomy and the surgical margins of the resected specimen must be histologically free of invasive adenocarcinoma and ductal carcinoma-in-situ (DCIS). - if the radial surgical margins are not histologically free of invasive adenocarcinoma and DCIS, these patients must proceed to a re-excision in order to obtain microscopically clear margins; when there is a close chest wall margin (i.e. fascia has been taken in the operative report), no further excision is required if a boost is delivered to the tumour bed - surgical margins involved with lobular carcinoma-in-situ (LCIS) will not be considered as a positive margin and therefore such patients would be eligible without additional resection - post-mastectomy surgical margins must be free of gross residual tumour – when post-mastectomy margins are microscopically positive, such patients will be eligible on the condition that it is agreed that adjuvant radiotherapy to the chest wall will be delivered. b) patients must have completed one of the following axillary procedure for the pathological evaluation of axillary lymph nodes I. sentinel node biopsy (SNB) or/and II. sampling procedure or/and III. axillary dissection - patients in whom a SNB yields metastatic nodal disease, must proceed to either the removal of additional non-sentinel lymph nodes or a completion axillary dissection to retrieve a minimum of 6 lymph nodes. Patients will be defined as having node negative disease following either a SNB/sampling procedure or after a minimum of 4 axillary nodes have been removed. 6. The interval between the last loco-regional surgery (including reexcision of involved surgical margins) and randomisation must be between 4–11 weeks. Etc.
    E.4Principal exclusion criteria
    Cancer history 1. Patients with T4 tumours (which includes inflammatory carcinomas and tumours with direct extension to the chest wall or directly involving the skin) 2. Patients in whom the surgeon was unable to surgically clear the axilla from all macroscopic disease / The presence of grossly microscopic evident extracapsular nodal extension Previous Cancer History 3. Prior history of breast cancer, including DCIS. (Patients with a history of LCIS are eligible) 4. Any previous malignancy treated with curative intent and the patient has been disease-free for less than 5 years prior to randomization – exceptions are: carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin 5. Any prior systemic chemotherapy for any malignancy or treatment with an anti-angiogenic treatment that modifies the VEGF molecular pathway. Previous chemotherapy for a nonmalignant disease should be discussed with a member of the medical support team Chemoprevention 6. Patients who are receiving chemoprevention with any hormonal agent such as raloxifene, tamoxifen or other SERM and are not willing to discontinue these medications prior to study entry Medical history 7. Clinically significant cardiac diseases including (a) Clinical evidence of transmural myocardial infarction. (b) Unstable angina (c) Evidence of ischaemic heart disease (IHD) [requiring antianginal medication with calcium channel blockers, nitrates and &#946;-blockers] (d) High risk uncontrolled arrhythmias (ventricular tachycardia, supraventricular tachycardia not adequately rate controlled and high grade atrio-ventricular block) (e) History of documented CHF or systolic dysfunction (LVEF < 55%) 8. Uncontrolled hypertension defined by a systolic pressure >150 mm Hg and/or diastolic pressure >90 mm Hg, with or without anti-hypertensive medication. Patients with initial blood pressure elevations are eligible if initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria. 9. History of transient ischaemic attacks (TIA) or cerebrovascular accident (CVA). 10. When the risk for the development of venous thrombo-embolism outweighs the benefits of participating in the trial. 11. Patients on a therapeutic dose of an anticoagulant for a venous thrombo-embolism (e.g. a deep venous thrombosis or pulmonary embolism). 12. History or evidence of an inherited bleeding diathesis or coagulopathy at risk of bleeding 13. Gastroduodenal ulcer(s) determined by endoscopy to be active 14. Patients with an infection requiring intravenous antibiotics at of randomisation 15. Patients who have any other disease, metabolic or psychological, or who have any evidence on clinical examination or special investigations (including a laboratory finding) which gives reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, or that may affect the patient’s compliance with study requirements, or would place the patient at higher risk of potential treatment complications. 16. Pregnant or breast-feeding women. Etc.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the present trial is Invasive Disease-Free Survival (IDFS). It is a composite endpoint which is defined as the time from randomisation until the date of the first occurrence of one of the following events: - An ipsilateral invasive breast cancer recurrence (i.e. an invasive breast cancer involving the same breast parenchyma as the original primary) - Ipsilateral local – regional invasive breast cancer recurrence (i.e. an invasive breast cancer in the axilla, regional lymph nodes, chest wall or/and skin of the ipsilateral breast) - Distant recurrence (i.e. evidence of breast cancer in any anatomic site – other than the two above mentioned sites – that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer) - Death attributable to any cause including breast cancer, nonbreast cancer or unknown cause. - Contralateral invasive breast cancer - Second primary non-breast invasive cancer (with the exception of non-melanoma skin cancers)
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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 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) 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 2007-11-09. 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 state158
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1245
    F.4.2.2In the whole clinical trial 2530
    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 Decision2008-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-30
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