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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00528567
Registration number
NCT00528567
Ethics application status
Date submitted
11/09/2007
Date registered
12/09/2007
Date last updated
4/09/2015
Titles & IDs
Public title
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
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Scientific title
An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.
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Secondary ID [1]
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0
2007-001128-11
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Secondary ID [2]
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BO20289
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Standard adjuvant chemotherapy
Experimental: Bevacizumab and Chemotherapy - Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
Active Comparator: Chemotherapy - Participants randomized to receive standard adjuvant chemotherapy as prescribed.
Treatment: Drugs: Bevacizumab
Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
Treatment: Drugs: Standard adjuvant chemotherapy
All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Invasive Disease-free Survival (IDFS) Event
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Assessment method [1]
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IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.
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Timepoint [1]
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Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Primary outcome [2]
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Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
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Assessment method [2]
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IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.
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Timepoint [2]
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Event driven (until data cutoff: 29 February 2012 up to 49 months)
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Primary outcome [3]
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Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
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Assessment method [3]
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IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.
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Timepoint [3]
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0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Primary outcome [4]
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Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
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Assessment method [4]
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IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.
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Timepoint [4]
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0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [1]
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Time to Overall Survival (OS) Event
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Assessment method [1]
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OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
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Timepoint [1]
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0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [2]
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Time to Overall Survival (OS) Event
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Assessment method [2]
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OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
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Timepoint [2]
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0
Event driven (until data cutoff: 30 June 2014: up to 77 months)
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Secondary outcome [3]
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Percentage of Participants With Overall Survival (OS) Event
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Assessment method [3]
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OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
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Timepoint [3]
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0
Event driven (until data cut off: 29 February 2012: up to 49 months)
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Secondary outcome [4]
0
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Percentage of Participants With Overall Survival (OS) Event
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Assessment method [4]
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OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
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Timepoint [4]
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0
Event driven (until data cut off: 30 June 2014: up to 77 months)
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Secondary outcome [5]
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Time to Breast Cancer-Free Interval (BCFI) Event
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Assessment method [5]
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BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.
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Timepoint [5]
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Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [6]
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Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events
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Assessment method [6]
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BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.
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Timepoint [6]
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Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [7]
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Time to Disease-Free Survival (DFS) Event
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Assessment method [7]
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DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).
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Timepoint [7]
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0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [8]
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Percentage of Participants With Disease-Free Survival (DFS) Events
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Assessment method [8]
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DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.
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Timepoint [8]
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Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [9]
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Time to Distant Disease-Free Survival (DDFS) Event
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Assessment method [9]
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DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).
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Timepoint [9]
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Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [10]
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Percentage of Participants With Distant Disease-Free Survival (DDFS) Events
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Assessment method [10]
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DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.
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Timepoint [10]
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Event driven (until data cutoff: 29 February 2012: up to 49 months)
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Secondary outcome [11]
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Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths
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Assessment method [11]
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An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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Timepoint [11]
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Through end of study: 30 June 2014: up to 77 months
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Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;
- operable primary invasive breast cancer;
- completed definitive loco-regional surgery;
- primary tumor centrally confirmed as triple negative.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- locally advanced breast cancers;
- previous breast cancer history;
- clinically significant cardiovascular disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2014
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Sample size
Target
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Accrual to date
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Final
2591
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Brisbane
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Recruitment hospital [2]
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- Camperdown
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Recruitment hospital [3]
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- East Bentleigh
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Recruitment hospital [4]
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- Fitzroy
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Recruitment hospital [5]
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- Geelong
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Recruitment hospital [6]
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- Heidelberg
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Recruitment hospital [7]
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- Kurralta Park
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Recruitment hospital [8]
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- Malvern
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Recruitment hospital [9]
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- Nambour
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Recruitment hospital [10]
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- Parkville
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Recruitment hospital [11]
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- Perth
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Recruitment hospital [12]
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- Port Macquarie
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Recruitment hospital [13]
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- St. Leonards
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- Sydney
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- Wahroonga
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- Waratah
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Recruitment hospital [17]
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- Wodonga
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Recruitment hospital [18]
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- Wollongong
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Recruitment postcode(s) [2]
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4104 - Brisbane
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Recruitment postcode(s) [3]
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2050 - Camperdown
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Recruitment postcode(s) [4]
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VIC 3165 - East Bentleigh
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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3084 - Heidelberg
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Recruitment postcode(s) [8]
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5035 - Kurralta Park
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Recruitment postcode(s) [9]
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3144 - Malvern
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Recruitment postcode(s) [10]
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4560 - Nambour
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Recruitment postcode(s) [11]
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3052 - Parkville
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Recruitment postcode(s) [12]
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6000 - Perth
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Recruitment postcode(s) [13]
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6008 - Perth
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Recruitment postcode(s) [14]
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2444 - Port Macquarie
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Recruitment postcode(s) [15]
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2065 - St. Leonards
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Recruitment postcode(s) [16]
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2031 - Sydney
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Recruitment postcode(s) [17]
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2060 - Sydney
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Recruitment postcode(s) [18]
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2065 - Sydney
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Recruitment postcode(s) [19]
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2139 - Sydney
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Recruitment postcode(s) [20]
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2076 - Wahroonga
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Recruitment postcode(s) [21]
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2298 - Waratah
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Recruitment postcode(s) [22]
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3690 - Wodonga
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Recruitment postcode(s) [23]
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2500 - Wollongong
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Iowa
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Maryland
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Michigan
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Missouri
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New York
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North Carolina
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Rosario
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Austria
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Bludesch
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Austria
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Graz
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Innsbruck
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Krems
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Leoben
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Linz
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Wolfsberg
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Baudour
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Belgium
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Bruxelles
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Hasselt
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Namur
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Belgium
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Sint-niklaas
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Belgium
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Tournai
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Wilrijk
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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Canada
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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China
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Beijing
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China
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Changchun
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China
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Chengdu
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China
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Fuzhou
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China
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Guangzhou
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China
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Hang Zhou
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China
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Shanghai
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China
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Suzhou
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China
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Tianjin
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China
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Wuhan
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China
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Zhejiang
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Costa Rica
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San Jose
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Czech Republic
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Brno
Query!
Country [73]
0
0
Czech Republic
Query!
State/province [73]
0
0
Novy Jicin
Query!
Country [74]
0
0
Czech Republic
Query!
State/province [74]
0
0
Olomouc
Query!
Country [75]
0
0
Czech Republic
Query!
State/province [75]
0
0
Pardubice
Query!
Country [76]
0
0
Czech Republic
Query!
State/province [76]
0
0
Praha
Query!
Country [77]
0
0
Finland
Query!
State/province [77]
0
0
Tampere
Query!
Country [78]
0
0
Finland
Query!
State/province [78]
0
0
Turku
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Angers
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Bayonne
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Besancon
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Bobigny
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Bordeaux
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Brest
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Clermont Ferrand
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Colmar
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Grenoble
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
La Chaussee St Victor
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Le Mans
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Lille
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Limoges
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Marseille
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Montbeliard
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Montpellier
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Mougins
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Nancy
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Neuilly Sur Seine
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Paris
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Rouen
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Saint-cloud
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Senlis
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Strasbourg
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Toulon
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Tours
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Berlin
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Bielefeld
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Bonn
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Chemnitz
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Coburg
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Dortmund
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Dresden
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Düsseldorf
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Frankfurt Am Main
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Freiburg
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Georgsmarienhütte
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Greifswald
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Hamburg
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Heidelberg
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Herne
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Kassel
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Kiel
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Koeln
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Krefeld
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Leipzig
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Lemgo
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Lüneburg
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Magdeburg
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Marburg
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
München
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Münster
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Offenbach
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Offenburg
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Recklinghausen
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Rosenheim
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Stade
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Trier
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Tübingen
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
ULM
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
WEIßENFELS
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Wiesbaden
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Witten
Query!
Country [142]
0
0
Greece
Query!
State/province [142]
0
0
Heraklion
Query!
Country [143]
0
0
Greece
Query!
State/province [143]
0
0
Patras
Query!
Country [144]
0
0
Greece
Query!
State/province [144]
0
0
Thessaloniki
Query!
Country [145]
0
0
Hong Kong
Query!
State/province [145]
0
0
Hong Kong
Query!
Country [146]
0
0
Israel
Query!
State/province [146]
0
0
Haifa
Query!
Country [147]
0
0
Israel
Query!
State/province [147]
0
0
Jerusalem
Query!
Country [148]
0
0
Israel
Query!
State/province [148]
0
0
Kfar Saba
Query!
Country [149]
0
0
Israel
Query!
State/province [149]
0
0
Petach Tikva
Query!
Country [150]
0
0
Israel
Query!
State/province [150]
0
0
Ramat-gan
Query!
Country [151]
0
0
Israel
Query!
State/province [151]
0
0
Rehovot
Query!
Country [152]
0
0
Israel
Query!
State/province [152]
0
0
Tel Aviv
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Aviano
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Bari
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Bergamo
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Brescia
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Brindisi
Query!
Country [158]
0
0
Italy
Query!
State/province [158]
0
0
Candiolo
Query!
Country [159]
0
0
Italy
Query!
State/province [159]
0
0
Cattolica
Query!
Country [160]
0
0
Italy
Query!
State/province [160]
0
0
Cesena
Query!
Country [161]
0
0
Italy
Query!
State/province [161]
0
0
Fano
Query!
Country [162]
0
0
Italy
Query!
State/province [162]
0
0
Genova
Query!
Country [163]
0
0
Italy
Query!
State/province [163]
0
0
Lecce
Query!
Country [164]
0
0
Italy
Query!
State/province [164]
0
0
Lido Di Camaiore
Query!
Country [165]
0
0
Italy
Query!
State/province [165]
0
0
Livorno
Query!
Country [166]
0
0
Italy
Query!
State/province [166]
0
0
Lugo
Query!
Country [167]
0
0
Italy
Query!
State/province [167]
0
0
Mantova
Query!
Country [168]
0
0
Italy
Query!
State/province [168]
0
0
Noale
Query!
Country [169]
0
0
Italy
Query!
State/province [169]
0
0
Padova
Query!
Country [170]
0
0
Italy
Query!
State/province [170]
0
0
Palermo
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Parma
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Pavia
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Potenza
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Ravenna
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
Rimini
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Roma
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Rozzano
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
San Giovanni Rotondo
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Sassari
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Taormina
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Treviglio
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Vecchiazzano
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Aichi
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Ehime
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Fukuoka
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Kyoto
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Osaka
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Saitama
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Tokyo
Query!
Country [190]
0
0
Korea, Republic of
Query!
State/province [190]
0
0
Kyunggi-do
Query!
Country [191]
0
0
Korea, Republic of
Query!
State/province [191]
0
0
Seoul
Query!
Country [192]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [192]
0
0
Skopje
Query!
Country [193]
0
0
Malaysia
Query!
State/province [193]
0
0
Kelantan
Query!
Country [194]
0
0
Malaysia
Query!
State/province [194]
0
0
Penang
Query!
Country [195]
0
0
Malaysia
Query!
State/province [195]
0
0
Petaling Jaya, Selangor
Query!
Country [196]
0
0
Malaysia
Query!
State/province [196]
0
0
Selangor
Query!
Country [197]
0
0
Mexico
Query!
State/province [197]
0
0
Leon
Query!
Country [198]
0
0
Mexico
Query!
State/province [198]
0
0
Monterrey
Query!
Country [199]
0
0
Netherlands
Query!
State/province [199]
0
0
Delftzijl
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Den Helder
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Groningen
Query!
Country [202]
0
0
Netherlands
Query!
State/province [202]
0
0
Tilburg
Query!
Country [203]
0
0
New Zealand
Query!
State/province [203]
0
0
Auckland
Query!
Country [204]
0
0
New Zealand
Query!
State/province [204]
0
0
Wellington
Query!
Country [205]
0
0
Peru
Query!
State/province [205]
0
0
Lima
Query!
Country [206]
0
0
Philippines
Query!
State/province [206]
0
0
Cebu
Query!
Country [207]
0
0
Philippines
Query!
State/province [207]
0
0
Quezon City
Query!
Country [208]
0
0
Poland
Query!
State/province [208]
0
0
Elblag
Query!
Country [209]
0
0
Poland
Query!
State/province [209]
0
0
Lodz
Query!
Country [210]
0
0
Poland
Query!
State/province [210]
0
0
Lublin
Query!
Country [211]
0
0
Poland
Query!
State/province [211]
0
0
Poznan
Query!
Country [212]
0
0
Poland
Query!
State/province [212]
0
0
Warsaw
Query!
Country [213]
0
0
Poland
Query!
State/province [213]
0
0
Warszawa
Query!
Country [214]
0
0
Portugal
Query!
State/province [214]
0
0
Coimbra
Query!
Country [215]
0
0
Portugal
Query!
State/province [215]
0
0
Lisboa
Query!
Country [216]
0
0
Romania
Query!
State/province [216]
0
0
Bucharest
Query!
Country [217]
0
0
Romania
Query!
State/province [217]
0
0
Cluj Napoca
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Chelyabinsk
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Ekaterinburg
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Ivanovo
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Kazan
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Moscow
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Obninsk
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Persochnysaint-petersburg
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Ryazan
Query!
Country [226]
0
0
Russian Federation
Query!
State/province [226]
0
0
Samara
Query!
Country [227]
0
0
Russian Federation
Query!
State/province [227]
0
0
St Petersburg
Query!
Country [228]
0
0
Russian Federation
Query!
State/province [228]
0
0
UFA
Query!
Country [229]
0
0
Serbia
Query!
State/province [229]
0
0
Belgrade
Query!
Country [230]
0
0
Serbia
Query!
State/province [230]
0
0
Sremska Kamenica
Query!
Country [231]
0
0
Singapore
Query!
State/province [231]
0
0
Singapore
Query!
Country [232]
0
0
South Africa
Query!
State/province [232]
0
0
Bloemfontein
Query!
Country [233]
0
0
South Africa
Query!
State/province [233]
0
0
Durban
Query!
Country [234]
0
0
South Africa
Query!
State/province [234]
0
0
Johannesburg
Query!
Country [235]
0
0
South Africa
Query!
State/province [235]
0
0
Pietermaritzburg
Query!
Country [236]
0
0
South Africa
Query!
State/province [236]
0
0
Pretoria
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Barcelona
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
Burgos
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Gijon
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Girona
Query!
Country [241]
0
0
Spain
Query!
State/province [241]
0
0
La Laguna
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Madrid
Query!
Country [243]
0
0
Spain
Query!
State/province [243]
0
0
Malaga
Query!
Country [244]
0
0
Spain
Query!
State/province [244]
0
0
Mataro
Query!
Country [245]
0
0
Spain
Query!
State/province [245]
0
0
Málaga
Query!
Country [246]
0
0
Spain
Query!
State/province [246]
0
0
Navarra
Query!
Country [247]
0
0
Spain
Query!
State/province [247]
0
0
Palma de Mallorca
Query!
Country [248]
0
0
Spain
Query!
State/province [248]
0
0
Pontevedra
Query!
Country [249]
0
0
Spain
Query!
State/province [249]
0
0
Terrassa
Query!
Country [250]
0
0
Spain
Query!
State/province [250]
0
0
Valencia
Query!
Country [251]
0
0
Spain
Query!
State/province [251]
0
0
Zaragoza
Query!
Country [252]
0
0
Sweden
Query!
State/province [252]
0
0
Eskilstuna
Query!
Country [253]
0
0
Sweden
Query!
State/province [253]
0
0
Gaevle
Query!
Country [254]
0
0
Sweden
Query!
State/province [254]
0
0
Lund
Query!
Country [255]
0
0
Sweden
Query!
State/province [255]
0
0
Malmoe
Query!
Country [256]
0
0
Sweden
Query!
State/province [256]
0
0
Umea
Query!
Country [257]
0
0
Sweden
Query!
State/province [257]
0
0
Uppsala
Query!
Country [258]
0
0
Switzerland
Query!
State/province [258]
0
0
Aarau
Query!
Country [259]
0
0
Switzerland
Query!
State/province [259]
0
0
Basel
Query!
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Switzerland
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Bern
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Switzerland
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Chur
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Switzerland
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Thun
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Switzerland
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Winterthur
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Switzerland
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Zürich
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Taiwan
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Changhua
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Tainan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Songkhla
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United Kingdom
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Belfast
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Birmingham
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Brighton
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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United Kingdom
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Chelsmford
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United Kingdom
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Colchester
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United Kingdom
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Dundee
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United Kingdom
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Edinburgh
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Epping
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United Kingdom
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Exeter
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United Kingdom
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Glasgow
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United Kingdom
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Guildford
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United Kingdom
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Huddersfield
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United Kingdom
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Ipswich
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United Kingdom
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Leeds
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London
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Manchester
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Merseyside
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Newcastle Upon Tyne
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Northwood
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United Kingdom
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Peterborough
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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Stoke-on-trent
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Truro
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United Kingdom
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Wolverhampton
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Funding & Sponsors
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Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
The main objective of the trial 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.
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
- evaluate the safety and tolerability of bevacizumab
An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or
serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab
to standard adjuvant systemic treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00528567
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00528567
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