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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.
Secondary ID [1] 0 0
2007-001128-11
Secondary ID [2] 0 0
BO20289
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Invasive Disease-free Survival (IDFS) Event - 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.
Timepoint [1] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Primary outcome [2] 0 0
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events - 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.
Timepoint [2] 0 0
Event driven (until data cutoff: 29 February 2012 up to 49 months)
Primary outcome [3] 0 0
Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer - 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.
Timepoint [3] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Primary outcome [4] 0 0
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer - 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.
Timepoint [4] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [1] 0 0
Time to Overall Survival (OS) Event - 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.
Timepoint [1] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [2] 0 0
Time to Overall Survival (OS) Event - 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.
Timepoint [2] 0 0
Event driven (until data cutoff: 30 June 2014: up to 77 months)
Secondary outcome [3] 0 0
Percentage of Participants With Overall Survival (OS) Event - 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.
Timepoint [3] 0 0
Event driven (until data cut off: 29 February 2012: up to 49 months)
Secondary outcome [4] 0 0
Percentage of Participants With Overall Survival (OS) Event - 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.
Timepoint [4] 0 0
Event driven (until data cut off: 30 June 2014: up to 77 months)
Secondary outcome [5] 0 0
Time to Breast Cancer-Free Interval (BCFI) Event - 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.
Timepoint [5] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [6] 0 0
Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events - 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.
Timepoint [6] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [7] 0 0
Time to Disease-Free Survival (DFS) Event - 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).
Timepoint [7] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [8] 0 0
Percentage of Participants With Disease-Free Survival (DFS) Events - 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.
Timepoint [8] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [9] 0 0
Time to Distant Disease-Free Survival (DDFS) Event - 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).
Timepoint [9] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [10] 0 0
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events - 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.
Timepoint [10] 0 0
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary outcome [11] 0 0
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths - 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.
Timepoint [11] 0 0
Through end of study: 30 June 2014: up to 77 months

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- locally advanced breast cancers;

- previous breast cancer history;

- clinically significant cardiovascular disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- East Bentleigh
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Heidelberg
Recruitment hospital [7] 0 0
- Kurralta Park
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Nambour
Recruitment hospital [10] 0 0
- Parkville
Recruitment hospital [11] 0 0
- Perth
Recruitment hospital [12] 0 0
- Port Macquarie
Recruitment hospital [13] 0 0
- St. Leonards
Recruitment hospital [14] 0 0
- Sydney
Recruitment hospital [15] 0 0
- Wahroonga
Recruitment hospital [16] 0 0
- Waratah
Recruitment hospital [17] 0 0
- Wodonga
Recruitment hospital [18] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
4104 - Brisbane
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
5035 - Kurralta Park
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
4560 - Nambour
Recruitment postcode(s) [11] 0 0
3052 - Parkville
Recruitment postcode(s) [12] 0 0
6000 - Perth
Recruitment postcode(s) [13] 0 0
6008 - Perth
Recruitment postcode(s) [14] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [15] 0 0
2065 - St. Leonards
Recruitment postcode(s) [16] 0 0
2031 - Sydney
Recruitment postcode(s) [17] 0 0
2060 - Sydney
Recruitment postcode(s) [18] 0 0
2065 - Sydney
Recruitment postcode(s) [19] 0 0
2139 - Sydney
Recruitment postcode(s) [20] 0 0
2076 - Wahroonga
Recruitment postcode(s) [21] 0 0
2298 - Waratah
Recruitment postcode(s) [22] 0 0
3690 - Wodonga
Recruitment postcode(s) [23] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Vermont
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario
Country [24] 0 0
Austria
State/province [24] 0 0
Bludesch
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Austria
State/province [26] 0 0
Innsbruck
Country [27] 0 0
Austria
State/province [27] 0 0
Krems
Country [28] 0 0
Austria
State/province [28] 0 0
Leoben
Country [29] 0 0
Austria
State/province [29] 0 0
Linz
Country [30] 0 0
Austria
State/province [30] 0 0
Salzburg
Country [31] 0 0
Austria
State/province [31] 0 0
Wels
Country [32] 0 0
Austria
State/province [32] 0 0
Wiener Neustadt
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
Country [34] 0 0
Austria
State/province [34] 0 0
Wolfsberg
Country [35] 0 0
Belgium
State/province [35] 0 0
Baudour
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Hasselt
Country [38] 0 0
Belgium
State/province [38] 0 0
Namur
Country [39] 0 0
Belgium
State/province [39] 0 0
Sint-niklaas
Country [40] 0 0
Belgium
State/province [40] 0 0
Tournai
Country [41] 0 0
Belgium
State/province [41] 0 0
Wilrijk
Country [42] 0 0
Bosnia and Herzegovina
State/province [42] 0 0
Sarajevo
Country [43] 0 0
Brazil
State/province [43] 0 0
Goiania
Country [44] 0 0
Brazil
State/province [44] 0 0
Ijui
Country [45] 0 0
Brazil
State/province [45] 0 0
JAU
Country [46] 0 0
Brazil
State/province [46] 0 0
Porto Alegre
Country [47] 0 0
Brazil
State/province [47] 0 0
Rio de Janeiro
Country [48] 0 0
Brazil
State/province [48] 0 0
Santo Andre
Country [49] 0 0
Brazil
State/province [49] 0 0
Sao Paulo
Country [50] 0 0
Brazil
State/province [50] 0 0
Sorocaba
Country [51] 0 0
Canada
State/province [51] 0 0
Alberta
Country [52] 0 0
Canada
State/province [52] 0 0
British Columbia
Country [53] 0 0
Canada
State/province [53] 0 0
Manitoba
Country [54] 0 0
Canada
State/province [54] 0 0
New Brunswick
Country [55] 0 0
Canada
State/province [55] 0 0
Newfoundland and Labrador
Country [56] 0 0
Canada
State/province [56] 0 0
Nova Scotia
Country [57] 0 0
Canada
State/province [57] 0 0
Ontario
Country [58] 0 0
Canada
State/province [58] 0 0
Quebec
Country [59] 0 0
Canada
State/province [59] 0 0
Saskatchewan
Country [60] 0 0
China
State/province [60] 0 0
Beijing
Country [61] 0 0
China
State/province [61] 0 0
Changchun
Country [62] 0 0
China
State/province [62] 0 0
Chengdu
Country [63] 0 0
China
State/province [63] 0 0
Fuzhou
Country [64] 0 0
China
State/province [64] 0 0
Guangzhou
Country [65] 0 0
China
State/province [65] 0 0
Hang Zhou
Country [66] 0 0
China
State/province [66] 0 0
Shanghai
Country [67] 0 0
China
State/province [67] 0 0
Suzhou
Country [68] 0 0
China
State/province [68] 0 0
Tianjin
Country [69] 0 0
China
State/province [69] 0 0
Wuhan
Country [70] 0 0
China
State/province [70] 0 0
Zhejiang
Country [71] 0 0
Costa Rica
State/province [71] 0 0
San Jose
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Brno
Country [73] 0 0
Czech Republic
State/province [73] 0 0
Novy Jicin
Country [74] 0 0
Czech Republic
State/province [74] 0 0
Olomouc
Country [75] 0 0
Czech Republic
State/province [75] 0 0
Pardubice
Country [76] 0 0
Czech Republic
State/province [76] 0 0
Praha
Country [77] 0 0
Finland
State/province [77] 0 0
Tampere
Country [78] 0 0
Finland
State/province [78] 0 0
Turku
Country [79] 0 0
France
State/province [79] 0 0
Angers
Country [80] 0 0
France
State/province [80] 0 0
Bayonne
Country [81] 0 0
France
State/province [81] 0 0
Besancon
Country [82] 0 0
France
State/province [82] 0 0
Bobigny
Country [83] 0 0
France
State/province [83] 0 0
Bordeaux
Country [84] 0 0
France
State/province [84] 0 0
Brest
Country [85] 0 0
France
State/province [85] 0 0
Clermont Ferrand
Country [86] 0 0
France
State/province [86] 0 0
Colmar
Country [87] 0 0
France
State/province [87] 0 0
Grenoble
Country [88] 0 0
France
State/province [88] 0 0
La Chaussee St Victor
Country [89] 0 0
France
State/province [89] 0 0
Le Mans
Country [90] 0 0
France
State/province [90] 0 0
Lille
Country [91] 0 0
France
State/province [91] 0 0
Limoges
Country [92] 0 0
France
State/province [92] 0 0
Marseille
Country [93] 0 0
France
State/province [93] 0 0
Montbeliard
Country [94] 0 0
France
State/province [94] 0 0
Montpellier
Country [95] 0 0
France
State/province [95] 0 0
Mougins
Country [96] 0 0
France
State/province [96] 0 0
Nancy
Country [97] 0 0
France
State/province [97] 0 0
Neuilly Sur Seine
Country [98] 0 0
France
State/province [98] 0 0
Paris
Country [99] 0 0
France
State/province [99] 0 0
Rouen
Country [100] 0 0
France
State/province [100] 0 0
Saint-cloud
Country [101] 0 0
France
State/province [101] 0 0
Senlis
Country [102] 0 0
France
State/province [102] 0 0
Strasbourg
Country [103] 0 0
France
State/province [103] 0 0
Toulon
Country [104] 0 0
France
State/province [104] 0 0
Tours
Country [105] 0 0
Germany
State/province [105] 0 0
Berlin
Country [106] 0 0
Germany
State/province [106] 0 0
Bielefeld
Country [107] 0 0
Germany
State/province [107] 0 0
Bonn
Country [108] 0 0
Germany
State/province [108] 0 0
Chemnitz
Country [109] 0 0
Germany
State/province [109] 0 0
Coburg
Country [110] 0 0
Germany
State/province [110] 0 0
Dortmund
Country [111] 0 0
Germany
State/province [111] 0 0
Dresden
Country [112] 0 0
Germany
State/province [112] 0 0
Düsseldorf
Country [113] 0 0
Germany
State/province [113] 0 0
Frankfurt Am Main
Country [114] 0 0
Germany
State/province [114] 0 0
Freiburg
Country [115] 0 0
Germany
State/province [115] 0 0
Georgsmarienhütte
Country [116] 0 0
Germany
State/province [116] 0 0
Greifswald
Country [117] 0 0
Germany
State/province [117] 0 0
Hamburg
Country [118] 0 0
Germany
State/province [118] 0 0
Heidelberg
Country [119] 0 0
Germany
State/province [119] 0 0
Herne
Country [120] 0 0
Germany
State/province [120] 0 0
Kassel
Country [121] 0 0
Germany
State/province [121] 0 0
Kiel
Country [122] 0 0
Germany
State/province [122] 0 0
Koeln
Country [123] 0 0
Germany
State/province [123] 0 0
Krefeld
Country [124] 0 0
Germany
State/province [124] 0 0
Leipzig
Country [125] 0 0
Germany
State/province [125] 0 0
Lemgo
Country [126] 0 0
Germany
State/province [126] 0 0
Lüneburg
Country [127] 0 0
Germany
State/province [127] 0 0
Magdeburg
Country [128] 0 0
Germany
State/province [128] 0 0
Marburg
Country [129] 0 0
Germany
State/province [129] 0 0
München
Country [130] 0 0
Germany
State/province [130] 0 0
Münster
Country [131] 0 0
Germany
State/province [131] 0 0
Offenbach
Country [132] 0 0
Germany
State/province [132] 0 0
Offenburg
Country [133] 0 0
Germany
State/province [133] 0 0
Recklinghausen
Country [134] 0 0
Germany
State/province [134] 0 0
Rosenheim
Country [135] 0 0
Germany
State/province [135] 0 0
Stade
Country [136] 0 0
Germany
State/province [136] 0 0
Trier
Country [137] 0 0
Germany
State/province [137] 0 0
Tübingen
Country [138] 0 0
Germany
State/province [138] 0 0
ULM
Country [139] 0 0
Germany
State/province [139] 0 0
WEIßENFELS
Country [140] 0 0
Germany
State/province [140] 0 0
Wiesbaden
Country [141] 0 0
Germany
State/province [141] 0 0
Witten
Country [142] 0 0
Greece
State/province [142] 0 0
Heraklion
Country [143] 0 0
Greece
State/province [143] 0 0
Patras
Country [144] 0 0
Greece
State/province [144] 0 0
Thessaloniki
Country [145] 0 0
Hong Kong
State/province [145] 0 0
Hong Kong
Country [146] 0 0
Israel
State/province [146] 0 0
Haifa
Country [147] 0 0
Israel
State/province [147] 0 0
Jerusalem
Country [148] 0 0
Israel
State/province [148] 0 0
Kfar Saba
Country [149] 0 0
Israel
State/province [149] 0 0
Petach Tikva
Country [150] 0 0
Israel
State/province [150] 0 0
Ramat-gan
Country [151] 0 0
Israel
State/province [151] 0 0
Rehovot
Country [152] 0 0
Israel
State/province [152] 0 0
Tel Aviv
Country [153] 0 0
Italy
State/province [153] 0 0
Aviano
Country [154] 0 0
Italy
State/province [154] 0 0
Bari
Country [155] 0 0
Italy
State/province [155] 0 0
Bergamo
Country [156] 0 0
Italy
State/province [156] 0 0
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00528567
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications