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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Sex
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
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
2591
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
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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
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2060 - Sydney
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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
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United States of America
State/province [2] 0 0
Arkansas
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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
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Georgia
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Illinois
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Iowa
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United States of America
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Maryland
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Michigan
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Missouri
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New Jersey
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New York
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North Carolina
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United States of America
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Ohio
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South Carolina
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Tennessee
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Texas
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United States of America
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Vermont
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Linz
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Salzburg
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Wels
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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/study/NCT00528567
Trial related presentations / publications
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.
Cameron 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.
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00528567