BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.
2 other identifiers
interventional
2,591
38 countries
385
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Dec 2007
Typical duration for phase_3 breast-cancer
385 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2007
CompletedFirst Posted
Study publicly available on registry
September 12, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedResults Posted
Study results publicly available
September 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedSeptember 4, 2015
August 1, 2015
4.2 years
September 11, 2007
February 28, 2013
August 5, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012 up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Secondary Outcomes (11)
Time to Overall Survival (OS) Event
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Time to Overall Survival (OS) Event
Event driven (until data cutoff: 30 June 2014: up to 77 months)
Percentage of Participants With Overall Survival (OS) Event
Event driven (until data cut off: 29 February 2012: up to 49 months)
Percentage of Participants With Overall Survival (OS) Event
Event driven (until data cut off: 30 June 2014: up to 77 months)
Time to Breast Cancer-Free Interval (BCFI) Event
Event driven (until data cutoff: 29 February 2012: up to 49 months)
- +6 more secondary outcomes
Study Arms (2)
Bevacizumab and Chemotherapy
EXPERIMENTALParticipants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
Chemotherapy
ACTIVE COMPARATORParticipants randomized to receive standard adjuvant chemotherapy as prescribed.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- operable primary invasive breast cancer;
- completed definitive loco-regional surgery;
- primary tumor centrally confirmed as triple negative.
You may not qualify if:
- locally advanced breast cancers;
- previous breast cancer history;
- clinically significant cardiovascular disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (403)
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Huntsville, Alabama, 35805, United States
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Mobile, Alabama, 36604, United States
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Fayetteville, Arkansas, 72703, United States
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Bakersfield, California, 93309, United States
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Fountain Valley, California, 92708, United States
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Greenbrae, California, 94904, United States
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Los Angeles, California, 90057, United States
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Pleasant Hill, California, 94523, United States
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Fairfield, Connecticut, 06824, United States
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Stamford, Connecticut, 06902, United States
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Washington D.C., District of Columbia, 20010, United States
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Gainesville, Florida, 32605, United States
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Orlando, Florida, 32806, United States
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Tamarac, Florida, 33321, United States
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Atlanta, Georgia, 30318, United States
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Augusta, Georgia, 30901, United States
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Lawrenceville, Georgia, 30046, United States
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Niles, Illinois, 60714, United States
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Iowa City, Iowa, 52242, United States
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Waterloo, Iowa, 50702, United States
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Baltimore, Maryland, 21215, United States
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Baltimore, Maryland, 21237, United States
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Rockville, Maryland, 20850-3348, United States
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Brownstown, Michigan, 48183, United States
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Kalamazoo, Michigan, 49007, United States
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Southfield, Michigan, 48075-3707, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63141, United States
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Long Branch, New Jersey, 07740, United States
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The Bronx, New York, 10469, United States
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Hickory, North Carolina, 28602, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45242, United States
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Columbus, Ohio, 43235, United States
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Middletown, Ohio, 45042, United States
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Columbia, South Carolina, 29210, United States
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Chattanooga, Tennessee, 37404, United States
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Germantown, Tennessee, 38138, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78759, United States
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Dallas, Texas, 75234, United States
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Rutland, Vermont, 05701, United States
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Abingdon, Virginia, 24211, United States
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Richmond, Virginia, 23230, United States
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Buenos Aires, C1405DCS, Argentina
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Rosario, S2002KDS, Argentina
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Brisbane, 4006, Australia
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Brisbane, 4104, Australia
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Camperdown, 2050, Australia
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East Bentleigh, VIC 3165, Australia
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Fitzroy, 3065, Australia
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Geelong, 3220, Australia
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Heidelberg, 3084, Australia
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Kurralta Park, 5035, Australia
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Malvern, 3144, Australia
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Nambour, 4560, Australia
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Parkville, 3052, Australia
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Perth, 6000, Australia
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Perth, 6008, Australia
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Port Macquarie, 2444, Australia
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St Leonards, 2065, Australia
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Sydney, 2031, Australia
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Sydney, 2060, Australia
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Sydney, 2065, Australia
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Sydney, 2139, Australia
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Wahroonga, 2076, Australia
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Waratah, 2298, Australia
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Wodonga, 3690, Australia
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Wollongong, 2500, Australia
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Bludesch, 6712, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Krems, 4560, Austria
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Leoben, 8700, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Wels, 4600, Austria
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Wiener Neustadt, 2700, Austria
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Wolfsberg, 9400, Austria
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Baudour, 7331, Belgium
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Brussels, 1090, Belgium
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Hasselt, 3500, Belgium
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Namur, 5000, Belgium
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Sint-Niklaas, 9100, Belgium
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Tournai, 7500, Belgium
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Wilrijk, 2610, Belgium
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Sarajevo, 71000, Bosnia and Herzegovina
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Goiânia, 74075-040, Brazil
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Ijuí, 98700-000, Brazil
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Jaú, 17210-120, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90430-090, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 22260-020, Brazil
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Santo André, 09060-870, Brazil
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São Paulo, 01209-010, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 05403, Brazil
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São Paulo, 1401000, Brazil
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Sorocaba, 18030-245, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Kingston, Ontario, K7L 5P9, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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London, Ontario, N6A 4L6, Canada
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Mississauga, Ontario, L5M 2N1, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Toronto, Ontario, M9N 1N8, Canada
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Windsor, Ontario, N8W 2X3, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Québec, Quebec, G1S 4L8, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Beijing, 100021, China
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Beijing, 100032, China
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Beijing, 100071, China
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Beijing, 100853, China
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Changchun, 130012, China
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Chengdu, 610041, China
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Fuzhou, 350025, China
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Guangzhou, 510060, China
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Hangzhou, 310022, China
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Shanghai, 200032, China
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Suzhou, 215006, China
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Tianjin, 300060, China
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Wuhan, 430030, China
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Zhejiang, 310003, China
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San José, 10103, Costa Rica
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Brno, 656 53, Czechia
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Nový Jičín, 741 01, Czechia
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Olomouc, 775 20, Czechia
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Pardubice, 532 03, Czechia
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Prague, 150 06, Czechia
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Tampere, 33520, Finland
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Turku, 20521, Finland
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Angers, 49933, France
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Bayonne, 64100, France
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Besançon, 25030, France
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Bobigny, 93009, France
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Bordeaux, 33077, France
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Brest, 29609, France
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Clermont-Ferrand, 63050, France
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Colmar, 68024, France
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Grenoble, 38100, France
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La Chaussée-Saint-Victor, 41260, France
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Le Mans, 72000, France
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Lille, 59000, France
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Lille, 59020, France
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Limoges, 87039, France
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Marseille, 13285, France
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Montbéliard, 25209, France
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Montpellier, 34298, France
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Mougins, 6250, France
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Nancy, 54100, France
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Neuilly-sur-Seine, 92200, France
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Paris, 75010, France
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Paris, 75231, France
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Paris, 75908, France
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Rouen, 76038, France
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Saint-Cloud, 92210, France
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Senlis, 60309, France
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Strasbourg, 67010, France
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Toulon, 83056, France
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Tours, 37044, France
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Berlin, 10317, Germany
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Berlin, 14195, Germany
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Bielefeld, 33604, Germany
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Bonn, 53111, Germany
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Chemnitz, 09116, Germany
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Coburg, 96450, Germany
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Cologne, 50924, Germany
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Dortmund, 44137, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40225, Germany
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Frankfurt am Main, 60389, Germany
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Freiburg im Breisgau, 79106, Germany
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Georgsmarienhütte, 49124, Germany
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Greifswald, 17475, Germany
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Hamburg, 20246, Germany
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Hamburg, 20357, Germany
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Heidelberg, 69115, Germany
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Herne, 44625, Germany
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Kassel, 34117, Germany
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Kiel, 24105, Germany
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Krefeld, 47805, Germany
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Leipzig, 04129, Germany
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Lemgo, 32657, Germany
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Lüneburg, 21339, Germany
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Magdeburg, 39108, Germany
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Marburg, 35043, Germany
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München, 81925, Germany
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Münster, 48149, Germany
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Offenbach, 63069, Germany
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Offenburg, 77654, Germany
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Recklinghausen, 45657, Germany
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Rosenheim, 83022, Germany
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Stade, 21680, Germany
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Trier, 54290, Germany
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Tübingen, 72076, Germany
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Ulm, 89075, Germany
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Weißenfels, 06667, Germany
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Wiesbaden, 65199, Germany
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Witten, 58452, Germany
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Heraklion, 71110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56429, Greece
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Aviano, 33081, Italy
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Bari, 70126, Italy
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Bergamo, 24128, Italy
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Brescia, 25123, Italy
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Brindisi, 72100, Italy
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Candiolo, 10060, Italy
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Cattolica, 47841, Italy
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Cesena, 47023, Italy
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Fano, 61032, Italy
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Genova, 16142, Italy
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Lecce, 73100, Italy
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Lido di Camaiore, 55043, Italy
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Livorno, 57100, Italy
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Lugo, Italy
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Mantova, 46100, Italy
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Noale, 30033, Italy
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Padua, 35128, Italy
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Palermo, 90146, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Potenza, 85100, Italy
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Ravenna, 48100, Italy
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Rimini, 47037, Italy
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Roma, 00144, Italy
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Roma, 00158, Italy
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Roma, 00161, Italy
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Rozzano, 20089, Italy
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San Giovanni Rotondo, 71013, Italy
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Sassari, 07100, Italy
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Taormina, 98039, Italy
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Treviglio, 24047, Italy
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Vecchiazzano, 47100, Italy
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Aichi, 464-8681, Japan
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Ehime, 791-0280, Japan
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Fukuoka, 811-1395, Japan
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Kyoto, 606-8507, Japan
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Osaka, 540-0006, Japan
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Saitama, 350-1298, Japan
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Tokyo, 104-0045, Japan
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Tokyo, 104-8560, Japan
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Tokyo, 113-8677, Japan
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Tokyo, 135-8550, Japan
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George Town, 11200, Malaysia
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Kelantan, Malaysia
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Kuala Selangor, 47500, Malaysia
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Petaling Jaya, Selangor, 46050, Malaysia
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León, 37000, Mexico
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Monterrey, 64020, Mexico
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Delftzijl, 9934 JD, Netherlands
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Den Helder, 1782GZ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Tilburg, 5042 AD, Netherlands
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Auckland, New Zealand
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Wellington, 6002, New Zealand
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Skopje, 1000, North Macedonia
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Lima, 11, Peru
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Cebu, 6000, Philippines
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Quezon City, 1114, Philippines
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Elblag, 82-300, Poland
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Lodz, 93-509, Poland
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Lublin, 20-081, Poland
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Lublin, 20-090, Poland
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Poznan, 61-878, Poland
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Warsaw, 02-781, Poland
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Warsaw, 61485, Poland
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Coimbra, 3000-075, Portugal
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Lisbon, 1099-023, Portugal
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Lisbon, 1649-035, Portugal
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Bucharest, 022328, Romania
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Cluj-Napoca, 400015, Romania
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Chelyabinsk, 454 087, Russia
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Ivanovo, 153040, Russia
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Kazan', 420029, Russia
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Kazan', 420111, Russia
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Moscow, 115478, Russia
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Moscow, 117837, Russia
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Moscow, 121356, Russia
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Obninsk, 249036, Russia
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Persochnysaint-petersburg, 197758, Russia
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Ryazan, 390011, Russia
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Saint Petersburg, Russia
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Samara, 443066, Russia
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Ufa, 450054, Russia
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Yekaterinburg, 620905, Russia
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Belgrade, 11000, Serbia
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Kamenitz, 21204, Serbia
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Singapore, 119228, Singapore
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Singapore, 169610, Singapore
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Bloemfontein, 9301, South Africa
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Durban, 4001, South Africa
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Johannesburg, 2196, South Africa
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Pietermaritzburg, 3201, South Africa
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Pretoria, 0002, South Africa
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Pretoria, 0181, South Africa
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Kyunggi-do, 411-769, South Korea
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Seoul, 110-744, South Korea
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Seoul, 135-170, South Korea
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Seoul, 137-702, South Korea
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Seoul, 138-736, South Korea
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Burgos, 09005, Spain
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Gijón, 33394, Spain
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Girona, 17007, Spain
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Madrid, 28033, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Madrid, 28222, Spain
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Mataró, 08304, Spain
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Málaga, 29010, Spain
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Navarra, 31008, Spain
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Palma de Mallorca, 07014, Spain
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Pontevedra, 36002, Spain
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San Cristóbal de La Laguna, 38320, Spain
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Terrassa, 08221, Spain
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Valencia, 41014, Spain
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Valencia, 46017, Spain
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Zaragoza, 50009, Spain
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Eskilstuna, 63188, Sweden
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Gävle, 80187, Sweden
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Lund, 22185, Sweden
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Malmo, 20502, Sweden
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Umeå, 90185, Sweden
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Uppsala, 751 85, Sweden
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Aarau, 5001, Switzerland
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Chur, 7000, Switzerland
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Thun, 3600, Switzerland
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Winterthur, 8401, Switzerland
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Zurich, 8008, Switzerland
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Changhua, 500, Taiwan
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Kaohsiung City, 807, Taiwan
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Kaohsiung City, 813, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taipei, 114, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Songkhla, 90110, Thailand
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Belfast, BT9 7AB, United Kingdom
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Birmingham, B15 2TT, United Kingdom
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Bournemouth, BH7 7DW, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Chelsmford, CM1 7ET, United Kingdom
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Colchester, CO3 3NB, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Epping, CM16 6TN, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Guildford, GU2 5XX, United Kingdom
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Huddersfield, HD3 3EA, United Kingdom
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Ipswich, IP4 5PD, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, EC1 A7BE, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Merseyside, CH63 45Y, United Kingdom
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Newcastle upon Tyne, NE4 6BE, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Peterborough, PE 3 9GZ, United Kingdom
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Sheffield, S1O 2SJ, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Stoke-on-Trent, ST4 7LN, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
Related Publications (2)
Bell R, Brown J, Parmar M, Toi M, Suter T, Steger GG, Pivot X, Mackey J, Jackisch C, Dent R, Hall P, Xu N, Morales L, Provencher L, Hegg R, Vanlemmens L, Kirsch A, Schneeweiss A, Masuda N, Overkamp F, Cameron D. Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Ann Oncol. 2017 Apr 1;28(4):754-760. doi: 10.1093/annonc/mdw665.
PMID: 27993816DERIVEDCameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. doi: 10.1016/S1470-2045(13)70335-8. Epub 2013 Aug 7.
PMID: 23932548DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2007
First Posted
September 12, 2007
Study Start
December 1, 2007
Primary Completion
February 1, 2012
Study Completion
June 1, 2014
Last Updated
September 4, 2015
Results First Posted
September 10, 2013
Record last verified: 2015-08