BEATRICE Study: A Study of Avastin (Bevacizumab) Adjuvant Therapy in Triple Negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00528567
First received: September 11, 2007
Last updated: September 17, 2013
Last verified: September 2013
Results First Received: February 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: bevacizumab [Avastin]
Drug: Standard adjuvant chemotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab and Chemotherapy bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
Chemotherapy Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.

Participant Flow:   Overall Study
    Bevacizumab and Chemotherapy     Chemotherapy  
STARTED     1301     1290  
Safety Population     1288     1271  
COMPLETED     870     982  
NOT COMPLETED     431     308  
Death                 4                 5  
Breast Cancer Recurrence/2nd Primary                 30                 60  
Adverse Event/Intermittent Illness                 255                 29  
Violation Criteria at Entry                 3                 17  
Withdrew Consent                 59                 55  
Refused Treatment/Did Not Cooperate                 52                 42  
Failure to Return                 1                 4  
Other Protocol Violation                 5                 21  
Administrative/Other                 22                 75  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bevacizumab and Chemotherapy bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
Chemotherapy Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.
Total Total of all reporting groups

Baseline Measures
    Bevacizumab and Chemotherapy     Chemotherapy     Total  
Number of Participants  
[units: participants]
  1301     1290     2591  
Age, Customized  
[units: participants]
     
< 40 years     231     253     484  
>= 40 to < 65 years     952     916     1868  
>= 65 years     118     121     239  
Gender  
[units: participants]
     
Female     1301     1290     2591  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Invasive Disease-free Survival (IDFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

2.  Primary:   Percentage of Participants With Invasive Disease-free Survival (IDFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

3.  Primary:   Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

4.  Primary:   Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

5.  Secondary:   Time to Overall Survival (OS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

6.  Secondary:   Percentage of Participants With Overall Survival (OS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

7.  Secondary:   Time to Breast Cancer-Free Interval (BCFI) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

8.  Secondary:   Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

9.  Secondary:   Time to Disease-Free Survival (DFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

10.  Secondary:   Percentage of Participants With Disease-Free Survival (DFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

11.  Secondary:   Time to Distant Disease-Free Survival (DDFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

12.  Secondary:   Percentage of Participants With Distant Disease-Free Survival (DDFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

13.  Secondary:   Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths   [ Time Frame: Up to 18 months for AEs and Up to 49 months for SAEs ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Up to 18 months for Adverse Events. Up to 49 Months for Serious Adverse Events.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Bevacizumab and Chemotherapy bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
Chemotherapy Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.

Other Adverse Events
    Bevacizumab and Chemotherapy     Chemotherapy  
Total, other (not including serious) adverse events      
# participants affected / at risk     1268/1288     1233/1271  
Blood and lymphatic system disorders      
Neutropenia † 1    
# participants affected / at risk     503/1288 (39.05%)     479/1271 (37.69%)  
Leukopenia † 1    
# participants affected / at risk     210/1288 (16.30%)     215/1271 (16.92%)  
Anaemia † 1    
# participants affected / at risk     140/1288 (10.87%)     175/1271 (13.77%)  
Cardiac disorders      
Left ventricular dysfunction † 1    
# participants affected / at risk     261/1288 (20.26%)     165/1271 (12.98%)  
Eye disorders      
Lacrimation increased † 1    
# participants affected / at risk     156/1288 (12.11%)     109/1271 (8.58%)  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     881/1288 (68.40%)     880/1271 (69.24%)  
Stomatitis † 1    
# participants affected / at risk     663/1288 (51.48%)     469/1271 (36.90%)  
Vomiting † 1    
# participants affected / at risk     480/1288 (37.27%)     459/1271 (36.11%)  
Constipation † 1    
# participants affected / at risk     444/1288 (34.47%)     401/1271 (31.55%)  
Diarrhoea † 1    
# participants affected / at risk     418/1288 (32.45%)     350/1271 (27.54%)  
Dyspepsia † 1    
# participants affected / at risk     201/1288 (15.61%)     165/1271 (12.98%)  
Abdominal pain upper † 1    
# participants affected / at risk     138/1288 (10.71%)     112/1271 (8.81%)  
Abdominal pain † 1    
# participants affected / at risk     123/1288 (9.55%)     124/1271 (9.76%)  
Gingival bleeding † 1    
# participants affected / at risk     138/1288 (10.71%)     10/1271 (0.79%)  
Dry mouth † 1    
# participants affected / at risk     61/1288 (4.74%)     76/1271 (5.98%)  
Haemorrhoids † 1    
# participants affected / at risk     78/1288 (6.06%)     58/1271 (4.56%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     533/1288 (41.38%)     539/1271 (42.41%)  
Asthenia † 1    
# participants affected / at risk     230/1288 (17.86%)     223/1271 (17.55%)  
Pyrexia † 1    
# participants affected / at risk     214/1288 (16.61%)     164/1271 (12.90%)  
Oedema peripheral † 1    
# participants affected / at risk     145/1288 (11.26%)     164/1271 (12.90%)  
Pain † 1    
# participants affected / at risk     72/1288 (5.59%)     58/1271 (4.56%)  
Influenza like illness † 1    
# participants affected / at risk     68/1288 (5.28%)     61/1271 (4.80%)  
Infections and infestations      
Nasopharyngitis † 1    
# participants affected / at risk     137/1288 (10.64%)     125/1271 (9.83%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     103/1288 (8.00%)     109/1271 (8.58%)  
Urinary tract infection † 1    
# participants affected / at risk     95/1288 (7.38%)     100/1271 (7.87%)  
Injury, poisoning and procedural complications      
Radiation skin injury † 1    
# participants affected / at risk     151/1288 (11.72%)     190/1271 (14.95%)  
Investigations      
Ejection fraction decreased † 1    
# participants affected / at risk     103/1288 (8.00%)     71/1271 (5.59%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     84/1288 (6.52%)     49/1271 (3.86%)  
Gamma-glutamyltransferase increased † 1    
# participants affected / at risk     82/1288 (6.37%)     45/1271 (3.54%)  
Alanine aminotransferase increased † 1    
# participants affected / at risk     67/1288 (5.20%)     50/1271 (3.93%)  
Weight decreased † 1    
# participants affected / at risk     72/1288 (5.59%)     28/1271 (2.20%)  
Metabolism and nutrition disorders      
Decreased appetite † 1    
# participants affected / at risk     260/1288 (20.19%)     223/1271 (17.55%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     414/1288 (32.14%)     252/1271 (19.83%)  
Myalgia † 1    
# participants affected / at risk     278/1288 (21.58%)     273/1271 (21.48%)  
Pain in extremity † 1    
# participants affected / at risk     198/1288 (15.37%)     171/1271 (13.45%)  
Back pain † 1    
# participants affected / at risk     172/1288 (13.35%)     141/1271 (11.09%)  
Bone pain † 1    
# participants affected / at risk     99/1288 (7.69%)     111/1271 (8.73%)  
Musculoskeletal pain † 1    
# participants affected / at risk     162/1288 (12.58%)     123/1271 (9.68%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     440/1288 (34.16%)     289/1271 (22.74%)  
Dysgeusia † 1    
# participants affected / at risk     243/1288 (18.87%)     230/1271 (18.10%)  
Neuropathy peripheral † 1    
# participants affected / at risk     138/1288 (10.71%)     135/1271 (10.62%)  
Peripheral sensory neuropathy † 1    
# participants affected / at risk     137/1288 (10.64%)     128/1271 (10.07%)  
Dizziness † 1    
# participants affected / at risk     130/1288 (10.09%)     121/1271 (9.52%)  
Paraesthesia † 1    
# participants affected / at risk     88/1288 (6.83%)     91/1271 (7.16%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     191/1288 (14.83%)     217/1271 (17.07%)  
Anxiety † 1    
# participants affected / at risk     88/1288 (6.83%)     78/1271 (6.14%)  
Depression † 1    
# participants affected / at risk     57/1288 (4.43%)     69/1271 (5.43%)  
Renal and urinary disorders      
Proteinuria † 1    
# participants affected / at risk     195/1288 (15.14%)     24/1271 (1.89%)  
Reproductive system and breast disorders      
Breast pain † 1    
# participants affected / at risk     60/1288 (4.66%)     86/1271 (6.77%)  
Respiratory, thoracic and mediastinal disorders      
Epistaxis † 1    
# participants affected / at risk     478/1288 (37.11%)     75/1271 (5.90%)  
Cough † 1    
# participants affected / at risk     215/1288 (16.69%)     161/1271 (12.67%)  
Oropharyngeal pain † 1    
# participants affected / at risk     179/1288 (13.90%)     99/1271 (7.79%)  
Dyspnoea † 1    
# participants affected / at risk     144/1288 (11.18%)     123/1271 (9.68%)  
Rhinorrhoea † 1    
# participants affected / at risk     104/1288 (8.07%)     65/1271 (5.11%)  
Dysphonia † 1    
# participants affected / at risk     99/1288 (7.69%)     19/1271 (1.49%)  
Skin and subcutaneous tissue disorders      
Alopecia † 1    
# participants affected / at risk     807/1288 (62.66%)     833/1271 (65.54%)  
Nail disorder † 1    
# participants affected / at risk     183/1288 (14.21%)     150/1271 (11.80%)  
Rash † 1    
# participants affected / at risk     160/1288 (12.42%)     137/1271 (10.78%)  
Erythema † 1    
# participants affected / at risk     86/1288 (6.68%)     114/1271 (8.97%)  
Palmar-Plantar erythrodysaesthesia syndrome † 1    
# participants affected / at risk     92/1288 (7.14%)     70/1271 (5.51%)  
Dry skin † 1    
# participants affected / at risk     70/1288 (5.43%)     72/1271 (5.66%)  
Pruritus † 1    
# participants affected / at risk     71/1288 (5.51%)     63/1271 (4.96%)  
Skin hyperpigmentation † 1    
# participants affected / at risk     68/1288 (5.28%)     49/1271 (3.86%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     456/1288 (35.40%)     65/1271 (5.11%)  
Hot flush † 1    
# participants affected / at risk     206/1288 (15.99%)     208/1271 (16.37%)  
Lymphoedema † 1    
# participants affected / at risk     70/1288 (5.43%)     74/1271 (5.82%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (15.0)



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00528567     History of Changes
Other Study ID Numbers: BO20289
Study First Received: September 11, 2007
Results First Received: February 28, 2013
Last Updated: September 17, 2013
Health Authority: France: AFSSAPS