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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/NCT00448591
Registration number
NCT00448591
Ethics application status
Date submitted
16/03/2007
Date registered
19/03/2007
Date last updated
25/05/2015
Titles & IDs
Public title
A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
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Scientific title
An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer
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Secondary ID [1]
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0
MO19391
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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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0
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Condition category
Condition code
Cancer
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0
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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 [Avastin]
Treatment: Drugs - Taxane-based chemotherapy
Experimental: 1 -
Treatment: Drugs: bevacizumab [Avastin]
10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
Treatment: Drugs: Taxane-based chemotherapy
As prescribed
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Intervention code [1]
0
0
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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Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)
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Assessment method [1]
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Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.
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Timepoint [1]
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Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion
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Secondary outcome [1]
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Percentage of Participants With Disease Progression
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Assessment method [1]
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Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
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Timepoint [1]
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Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
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Secondary outcome [2]
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Time to Progression (TTP)
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Assessment method [2]
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TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.
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Timepoint [2]
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Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
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Secondary outcome [3]
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Percentage of Participants With Recorded Death
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Assessment method [3]
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Timepoint [3]
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Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.
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Timepoint [4]
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Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months
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Secondary outcome [5]
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Percentage of Participants by Best Overall Response to Treatment
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Assessment method [5]
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Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.
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Timepoint [5]
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Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months
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Eligibility
Key inclusion criteria
- patients, >=18 years of age;
- HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic
disease; (HER-2 positive patients only if previously treated with Herceptin in the
adjuvant setting;
- candidates for chemotherapy.
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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
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- concomitant hormonal therapy for metastatic or locally recurrent disease;
- concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2
positive disease;
- previous radiotherapy for treatment of metastatic disease;
- evidence of CNS metastases.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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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
1/09/2006
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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
1/02/2013
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Sample size
Target
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Accrual to date
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Final
2296
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Darlinghurst
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- East Melbourne
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- Frankston
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- Gosford
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- Lismore
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- Maroochydore
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- Milton
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- Perth
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- Richmond
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- St. Leonards
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- Sydney
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- Wodonga
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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2250 - Gosford
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Recruitment postcode(s) [6]
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2480 - Lismore
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Recruitment postcode(s) [7]
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4558 - Maroochydore
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Recruitment postcode(s) [8]
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4064 - Milton
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Recruitment postcode(s) [9]
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6000 - Perth
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Recruitment postcode(s) [10]
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3121 - Richmond
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Recruitment postcode(s) [11]
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2065 - St. Leonards
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Recruitment postcode(s) [12]
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2031 - Sydney
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Recruitment postcode(s) [13]
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2060 - Sydney
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Recruitment postcode(s) [14]
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3690 - Wodonga
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Recruitment outside Australia
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Argentina
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Buenos Aires
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La Plata
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Linz
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0
Pierre Benite
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Pontoise
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Reims
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Rouen
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Saint Brieuc
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Saint Gregoire
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Saint Jean
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Saint Pierre
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Saint-cloud
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Saint-denis de La Reunion
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
St-priest-en-jarez
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Strasbourg
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Toulon
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Toulouse
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Tours
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Valenciennes
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Vandoeuvre Les Nancy
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Vannes
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Villeneuve-sur-lot
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Augsburg
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Bad Saarow
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Berlin
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Bielefeld
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Bochum
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Böblingen
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Chemnitz
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Cottbus
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Deggendorf
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Dresden
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Duisburg
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Düsseldorf
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Erfurt
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Essen
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Frankfurt
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Freiburg
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Halle
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Hamburg
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Hannover
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Kassel
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Kiel
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Leipzig
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Lübeck
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Magdeburg
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Mainz
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Mannheim
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
München
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Regensburg
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Rostock
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Saarbruecken
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Stralsund
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Stuttgart
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Troisdorf
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
ULM
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Unna
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Wiesbaden
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Wuerselen
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Wuppertal
Query!
Country [181]
0
0
Hong Kong
Query!
State/province [181]
0
0
Hong Kong
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Budapest
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Szeged
Query!
Country [184]
0
0
Israel
Query!
State/province [184]
0
0
Beer Sheva
Query!
Country [185]
0
0
Israel
Query!
State/province [185]
0
0
Haifa
Query!
Country [186]
0
0
Israel
Query!
State/province [186]
0
0
Holon
Query!
Country [187]
0
0
Israel
Query!
State/province [187]
0
0
Jerusalem
Query!
Country [188]
0
0
Israel
Query!
State/province [188]
0
0
Kfar Saba
Query!
Country [189]
0
0
Israel
Query!
State/province [189]
0
0
Nahariya
Query!
Country [190]
0
0
Israel
Query!
State/province [190]
0
0
Petach Tikva
Query!
Country [191]
0
0
Israel
Query!
State/province [191]
0
0
Ramat-gan
Query!
Country [192]
0
0
Israel
Query!
State/province [192]
0
0
Rehovot
Query!
Country [193]
0
0
Israel
Query!
State/province [193]
0
0
Safed
Query!
Country [194]
0
0
Israel
Query!
State/province [194]
0
0
Tel Aviv
Query!
Country [195]
0
0
Israel
Query!
State/province [195]
0
0
Zerifin
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Ancona
Query!
Country [197]
0
0
Italy
Query!
State/province [197]
0
0
Aviano
Query!
Country [198]
0
0
Italy
Query!
State/province [198]
0
0
Brescia
Query!
Country [199]
0
0
Italy
Query!
State/province [199]
0
0
Cagliari
Query!
Country [200]
0
0
Italy
Query!
State/province [200]
0
0
Candiolo
Query!
Country [201]
0
0
Italy
Query!
State/province [201]
0
0
Carpi
Query!
Country [202]
0
0
Italy
Query!
State/province [202]
0
0
Castelfranco Veneto
Query!
Country [203]
0
0
Italy
Query!
State/province [203]
0
0
Castrovillari
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Catania
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Chieti
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Como
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
Cremona
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Frattamaggiore
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Genova
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Lecce
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Lido Di Camaiore
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Lucca
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Mantova
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Messina
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Milano
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Montevarchi
Query!
Country [217]
0
0
Italy
Query!
State/province [217]
0
0
Napoli
Query!
Country [218]
0
0
Italy
Query!
State/province [218]
0
0
Novara
Query!
Country [219]
0
0
Italy
Query!
State/province [219]
0
0
Palermo
Query!
Country [220]
0
0
Italy
Query!
State/province [220]
0
0
Paola
Query!
Country [221]
0
0
Italy
Query!
State/province [221]
0
0
Pavia
Query!
Country [222]
0
0
Italy
Query!
State/province [222]
0
0
Piove Di Sacco
Query!
Country [223]
0
0
Italy
Query!
State/province [223]
0
0
Pordenone
Query!
Country [224]
0
0
Italy
Query!
State/province [224]
0
0
Pozzuoli
Query!
Country [225]
0
0
Italy
Query!
State/province [225]
0
0
Prato
Query!
Country [226]
0
0
Italy
Query!
State/province [226]
0
0
Ravenna
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
Rionero in Vulture
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Roma
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Salerno
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
San Giovanni Rotondo
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Saronno
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Sassari
Query!
Country [233]
0
0
Italy
Query!
State/province [233]
0
0
Siena
Query!
Country [234]
0
0
Italy
Query!
State/province [234]
0
0
Torino
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Verona
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Vicenza
Query!
Country [237]
0
0
Latvia
Query!
State/province [237]
0
0
Riga
Query!
Country [238]
0
0
Lebanon
Query!
State/province [238]
0
0
Beirut
Query!
Country [239]
0
0
Lithuania
Query!
State/province [239]
0
0
Kaunas
Query!
Country [240]
0
0
Lithuania
Query!
State/province [240]
0
0
Klaipeda
Query!
Country [241]
0
0
Lithuania
Query!
State/province [241]
0
0
Vilnius
Query!
Country [242]
0
0
Mexico
Query!
State/province [242]
0
0
Chihuahua
Query!
Country [243]
0
0
Mexico
Query!
State/province [243]
0
0
Ciudad Juarez
Query!
Country [244]
0
0
Mexico
Query!
State/province [244]
0
0
Guadalajara
Query!
Country [245]
0
0
Mexico
Query!
State/province [245]
0
0
Leon
Query!
Country [246]
0
0
Mexico
Query!
State/province [246]
0
0
Mexico City
Query!
Country [247]
0
0
Mexico
Query!
State/province [247]
0
0
Puebla
Query!
Country [248]
0
0
Mexico
Query!
State/province [248]
0
0
Tijuana
Query!
Country [249]
0
0
Morocco
Query!
State/province [249]
0
0
Rabat
Query!
Country [250]
0
0
Netherlands
Query!
State/province [250]
0
0
Ac Amsterdam
Query!
Country [251]
0
0
Netherlands
Query!
State/province [251]
0
0
Blaricum
Query!
Country [252]
0
0
Netherlands
Query!
State/province [252]
0
0
Capelle Ad Yssel
Query!
Country [253]
0
0
Netherlands
Query!
State/province [253]
0
0
Delftzijl
Query!
Country [254]
0
0
Netherlands
Query!
State/province [254]
0
0
Doetinchem
Query!
Country [255]
0
0
Netherlands
Query!
State/province [255]
0
0
Goes
Query!
Country [256]
0
0
Netherlands
Query!
State/province [256]
0
0
Hoofddorp
Query!
Country [257]
0
0
Netherlands
Query!
State/province [257]
0
0
Vlissingen
Query!
Country [258]
0
0
Netherlands
Query!
State/province [258]
0
0
Zoetermeer
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Bydgoszcz
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Lublin
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Olsztyn
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Poznan
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Warszawa
Query!
Country [264]
0
0
Portugal
Query!
State/province [264]
0
0
Almada
Query!
Country [265]
0
0
Portugal
Query!
State/province [265]
0
0
Aveiro
Query!
Country [266]
0
0
Portugal
Query!
State/province [266]
0
0
Barreiro
Query!
Country [267]
0
0
Portugal
Query!
State/province [267]
0
0
Beja
Query!
Country [268]
0
0
Portugal
Query!
State/province [268]
0
0
Cascais
Query!
Country [269]
0
0
Portugal
Query!
State/province [269]
0
0
Coimbra
Query!
Country [270]
0
0
Portugal
Query!
State/province [270]
0
0
Lisboa
Query!
Country [271]
0
0
Portugal
Query!
State/province [271]
0
0
Porto
Query!
Country [272]
0
0
Portugal
Query!
State/province [272]
0
0
Santa Maria Da Feira
Query!
Country [273]
0
0
Portugal
Query!
State/province [273]
0
0
Santarém
Query!
Country [274]
0
0
Portugal
Query!
State/province [274]
0
0
Setubal
Query!
Country [275]
0
0
Portugal
Query!
State/province [275]
0
0
Vila Nova de Gaia
Query!
Country [276]
0
0
Russian Federation
Query!
State/province [276]
0
0
Balashikha
Query!
Country [277]
0
0
Russian Federation
Query!
State/province [277]
0
0
Barnaul
Query!
Country [278]
0
0
Russian Federation
Query!
State/province [278]
0
0
Ekaterinburg
Query!
Country [279]
0
0
Russian Federation
Query!
State/province [279]
0
0
Engels
Query!
Country [280]
0
0
Russian Federation
Query!
State/province [280]
0
0
Izhevsk
Query!
Country [281]
0
0
Russian Federation
Query!
State/province [281]
0
0
Kazan
Query!
Country [282]
0
0
Russian Federation
Query!
State/province [282]
0
0
Kursk
Query!
Country [283]
0
0
Russian Federation
Query!
State/province [283]
0
0
Moscow
Query!
Country [284]
0
0
Russian Federation
Query!
State/province [284]
0
0
Smolensk
Query!
Country [285]
0
0
Russian Federation
Query!
State/province [285]
0
0
St Petersburg
Query!
Country [286]
0
0
Russian Federation
Query!
State/province [286]
0
0
Stavropol
Query!
Country [287]
0
0
Russian Federation
Query!
State/province [287]
0
0
Tumen
Query!
Country [288]
0
0
Russian Federation
Query!
State/province [288]
0
0
Tver
Query!
Country [289]
0
0
Russian Federation
Query!
State/province [289]
0
0
UFA
Query!
Country [290]
0
0
Russian Federation
Query!
State/province [290]
0
0
Ulyanovsk
Query!
Country [291]
0
0
Saudi Arabia
Query!
State/province [291]
0
0
Jeddah
Query!
Country [292]
0
0
Saudi Arabia
Query!
State/province [292]
0
0
Riyadh
Query!
Country [293]
0
0
Slovakia
Query!
State/province [293]
0
0
Banska Bystrica
Query!
Country [294]
0
0
Slovakia
Query!
State/province [294]
0
0
Bratislava
Query!
Country [295]
0
0
Slovakia
Query!
State/province [295]
0
0
Kosice
Query!
Country [296]
0
0
Slovakia
Query!
State/province [296]
0
0
Poprad
Query!
Country [297]
0
0
Slovakia
Query!
State/province [297]
0
0
Presov
Query!
Country [298]
0
0
Slovakia
Query!
State/province [298]
0
0
Zilina
Query!
Country [299]
0
0
Slovenia
Query!
State/province [299]
0
0
Ljubljana
Query!
Country [300]
0
0
Spain
Query!
State/province [300]
0
0
Alcorcon
Query!
Country [301]
0
0
Spain
Query!
State/province [301]
0
0
Barakaldo
Query!
Country [302]
0
0
Spain
Query!
State/province [302]
0
0
Barcelona
Query!
Country [303]
0
0
Spain
Query!
State/province [303]
0
0
Castellon
Query!
Country [304]
0
0
Spain
Query!
State/province [304]
0
0
Gijon
Query!
Country [305]
0
0
Spain
Query!
State/province [305]
0
0
Las Palmas de Gran Canaria
Query!
Country [306]
0
0
Spain
Query!
State/province [306]
0
0
Logroño
Query!
Country [307]
0
0
Spain
Query!
State/province [307]
0
0
Madrid
Query!
Country [308]
0
0
Spain
Query!
State/province [308]
0
0
Manresa
Query!
Country [309]
0
0
Spain
Query!
State/province [309]
0
0
Murcia
Query!
Country [310]
0
0
Spain
Query!
State/province [310]
0
0
Navarra
Query!
Country [311]
0
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Spain
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Orense
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Spain
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Palma de Mallorca
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Spain
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Pontevedra
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Spain
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Sabadell, Barcelona
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Sagunto
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Salamanca
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Spain
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San Sebastian
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Santiago de Compostela
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Spain
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Terrassa
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Valencia
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Vigo
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Spain
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Zamora
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Sweden
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Göteborg
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Jonkoping
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Sweden
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Kalmar
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Sweden
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Karlstad
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Sweden
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Malmoe
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Sweden
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Stockholm
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Sundsvall
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Vaxjo
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Västerås
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Switzerland
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Aarau
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Biel
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Genolier
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Locarno
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Switzerland
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Lugano
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Gaziantep
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Istanbul
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Turkey
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Shhiye, Ankara
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United Kingdom
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Colchester
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United Kingdom
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Coventry
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United Kingdom
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Dundee
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Peterborough
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United Kingdom
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Sutton
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United Kingdom
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Truro
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United Kingdom
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Westcliffe-on-sea
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United Kingdom
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Worthing
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a
taxane, with or without additional chemotherapy, as first-line treatment in patients with
locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv
every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are
contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal
doxorubicin) may be used. The anticipated time on study treatment is until disease
progression, and the target sample size is 500+ individuals.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00448591
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00448591
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