Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech
AstraZeneca
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00405938
First received: November 28, 2006
Last updated: December 5, 2013
Last verified: December 2013
Results First Received: January 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Breast Neoplasms
Interventions: Drug: Bevacizumab
Drug: Anastrozole
Drug: Fulvestrant

  Participant Flow
  Hide Participant Flow

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/Anastrozole Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
Bevacizumab/Fulvestrant Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.

Participant Flow:   Overall Study
    Bevacizumab/Anastrozole     Bevacizumab/Fulvestrant  
STARTED     38     41  
COMPLETED     38     41  
NOT COMPLETED     0     0  



  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/Anastrozole Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
Bevacizumab/Fulvestrant Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
Total Total of all reporting groups

Baseline Measures
    Bevacizumab/Anastrozole     Bevacizumab/Fulvestrant     Total  
Number of Participants  
[units: participants]
  38     41     79  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 37 to 85 )  
  63  
  ( 48 to 88 )  
  63  
  ( 37 to 88 )  
Gender  
[units: participants]
     
Female     38     41     79  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     38     41     79  



  Outcome Measures

1.  Primary:   Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease   [ Time Frame: 18 months ]

2.  Secondary:   Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment   [ Time Frame: 18 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

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

Reporting Groups
  Description
Bevacizumab/Anastrozole Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
Bevacizumab/Fulvestrant Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.

Other Adverse Events
    Bevacizumab/Anastrozole     Bevacizumab/Fulvestrant  
Total, other (not including serious) adverse events      
# participants affected / at risk     38/38     41/41  
Blood and lymphatic system disorders      
Edema - Limb † 1    
# participants affected / at risk     5/38 (13.16%)     7/41 (17.07%)  
# events     46     33  
Edema - NOS † 1    
# participants affected / at risk     3/38 (7.89%)     0/41 (0.00%)  
# events     23     0  
Hemoglobin † 1    
# participants affected / at risk     13/38 (34.21%)     12/41 (29.27%)  
# events     57     44  
Hemorrhage - Nose † 1    
# participants affected / at risk     8/38 (21.05%)     10/41 (24.39%)  
# events     14     21  
Leukopenia † 1    
# participants affected / at risk     5/38 (13.16%)     8/41 (19.51%)  
# events     13     19  
Lymphedema † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     7     0  
Neutrophils † 1    
# participants affected / at risk     2/38 (5.26%)     3/41 (7.32%)  
# events     46     4  
Platelets † 1    
# participants affected / at risk     8/38 (21.05%)     4/41 (9.76%)  
# events     41     11  
Cardiac disorders      
Cardiac Genral, Other (Decreased LVEF) † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Hypertension † 1    
# participants affected / at risk     18/38 (47.37%)     20/41 (48.78%)  
# events     70     110  
Hypotension † 1    
# participants affected / at risk     0/38 (0.00%)     5/41 (12.20%)  
# events     0     6  
Endocrine disorders      
Hot Flashes † 1    
# participants affected / at risk     13/38 (34.21%)     8/41 (19.51%)  
# events     51     23  
Gastrointestinal disorders      
Anorexia † 1    
# participants affected / at risk     7/38 (18.42%)     7/41 (17.07%)  
# events     23     27  
Constipation † 1    
# participants affected / at risk     5/38 (13.16%)     7/41 (17.07%)  
# events     11     8  
Dehydration † 1    
# participants affected / at risk     2/38 (5.26%)     5/41 (12.20%)  
# events     2     6  
Diarrhea † 1    
# participants affected / at risk     9/38 (23.68%)     9/41 (21.95%)  
# events     18     12  
Heartburn † 1    
# participants affected / at risk     4/38 (10.53%)     7/41 (17.07%)  
# events     17     27  
Hemorrhoids † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     10     0  
Mucositis/Stomatitis † 1    
# participants affected / at risk     4/38 (10.53%)     7/41 (17.07%)  
# events     4     20  
Nausea † 1    
# participants affected / at risk     14/38 (36.84%)     12/41 (29.27%)  
# events     48     44  
Taste Alteration † 1    
# participants affected / at risk     3/38 (7.89%)     0/41 (0.00%)  
# events     20     0  
Vomiting † 1    
# participants affected / at risk     7/38 (18.42%)     5/41 (12.20%)  
# events     14     7  
General disorders      
Fatigue † 1    
# participants affected / at risk     22/38 (57.89%)     30/41 (73.17%)  
# events     168     170  
Fever † 1    
# participants affected / at risk     4/38 (10.53%)     3/41 (7.32%)  
# events     4     5  
Pain - Head † 1    
# participants affected / at risk     17/38 (44.74%)     3/41 (7.32%)  
# events     53     3  
Insomnia † 1    
# participants affected / at risk     5/38 (13.16%)     4/41 (9.76%)  
# events     13     10  
Pain - Abdomen † 1    
# participants affected / at risk     4/38 (10.53%)     0/41 (0.00%)  
# events     22     0  
Pain - Back † 1    
# participants affected / at risk     8/38 (21.05%)     12/41 (29.27%)  
# events     39     24  
Pain - Bladder † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Pain - Bone † 1    
# participants affected / at risk     4/38 (10.53%)     7/41 (17.07%)  
# events     9     61  
Pain - Breast † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Pain - Chest Wall † 1    
# participants affected / at risk     6/38 (15.79%)     5/41 (12.20%)  
# events     6     12  
Pain - Ear † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     6     0  
Pain - Joint † 1    
# participants affected / at risk     11/38 (28.95%)     10/41 (24.39%)  
# events     37     28  
Pain - Limb † 1    
# participants affected / at risk     13/38 (34.21%)     12/41 (29.27%)  
# events     81     32  
Pain - Muscle † 1    
# participants affected / at risk     4/38 (10.53%)     3/41 (7.32%)  
# events     10     9  
Pain - Neck † 1    
# participants affected / at risk     3/38 (7.89%)     0/41 (0.00%)  
# events     24     0  
Pain - NOS † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     9     0  
Pain - Pelvis † 1    
# participants affected / at risk     0/38 (0.00%)     3/41 (7.32%)  
# events     0     10  
Rigor/Chills † 1    
# participants affected / at risk     2/38 (5.26%)     3/41 (7.32%)  
# events     2     8  
Sweating † 1    
# participants affected / at risk     0/38 (0.00%)     4/41 (9.76%)  
# events     0     11  
Weakness † 1    
# participants affected / at risk     5/38 (13.16%)     0/41 (0.00%)  
# events     11     0  
Infections and infestations      
Infection - Dental † 1    
# participants affected / at risk     0/38 (0.00%)     3/41 (7.32%)  
# events     0     6  
Infection - Ear † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     6     0  
Infection - Sinus † 1    
# participants affected / at risk     4/38 (10.53%)     4/41 (9.76%)  
# events     16     5  
Infection - Skin † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Infection - Bladder † 1    
# participants affected / at risk     6/38 (15.79%)     3/41 (7.32%)  
# events     9     6  
Infection - Pulmonary † 1    
# participants affected / at risk     4/38 (10.53%)     0/41 (0.00%)  
# events     5     0  
Metabolism and nutrition disorders      
AST † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     4     0  
Bilirubin † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     3     0  
Creatinine † 1    
# participants affected / at risk     0/38 (0.00%)     3/41 (7.32%)  
# events     0     20  
Hypercalcemia † 1    
# participants affected / at risk     3/38 (7.89%)     3/41 (7.32%)  
# events     8     5  
Hyperglycemia † 1    
# participants affected / at risk     3/38 (7.89%)     3/41 (7.32%)  
# events     7     7  
Hypocalcemia † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Hypokalemia † 1    
# participants affected / at risk     0/38 (0.00%)     3/41 (7.32%)  
# events     0     3  
Proteinuria † 1    
# participants affected / at risk     13/38 (34.21%)     18/41 (43.90%)  
# events     97     91  
Weight Loss † 1    
# participants affected / at risk     4/38 (10.53%)     3/41 (7.32%)  
# events     32     4  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     13/38 (34.21%)     10/41 (24.39%)  
# events     121     34  
Myalgia † 1    
# participants affected / at risk     4/38 (10.53%)     5/41 (12.20%)  
# events     9     14  
Nervous system disorders      
Confusion † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Dizziness † 1    
# participants affected / at risk     4/38 (10.53%)     9/41 (21.95%)  
# events     9     22  
Neuropathy - Motor † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     5     0  
Neuropathy - Sensory † 1    
# participants affected / at risk     7/38 (18.42%)     9/41 (21.95%)  
# events     12     15  
Psychiatric disorders      
Mood Alteration - Anxiety † 1    
# participants affected / at risk     5/38 (13.16%)     6/41 (14.63%)  
# events     18     18  
Mood Alteration - Depression † 1    
# participants affected / at risk     4/38 (10.53%)     4/41 (9.76%)  
# events     19     26  
Mood Alteration - NOS † 1    
# participants affected / at risk     3/38 (7.89%)     0/41 (0.00%)  
# events     11     0  
Renal and urinary disorders      
Renal Insufficiency † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     7/38 (18.42%)     8/41 (19.51%)  
# events     10     29  
Dyspnea † 1    
# participants affected / at risk     6/38 (15.79%)     9/41 (21.95%)  
# events     9     13  
Pleural Effusion † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Rhinitis † 1    
# participants affected / at risk     9/38 (23.68%)     7/41 (17.07%)  
# events     32     38  
Voice Changes † 1    
# participants affected / at risk     0/38 (0.00%)     5/41 (12.20%)  
# events     0     28  
Skin and subcutaneous tissue disorders      
Bruising † 1    
# participants affected / at risk     0/38 (0.00%)     3/41 (7.32%)  
# events     0     3  
Injection Site Reaction † 1    
# participants affected / at risk     0/38 (0.00%)     3/41 (7.32%)  
# events     0     3  
Pruritis † 1    
# participants affected / at risk     3/38 (7.89%)     0/41 (0.00%)  
# events     3     0  
Rash/Desquamation † 1    
# participants affected / at risk     4/38 (10.53%)     5/41 (12.20%)  
# events     14     6  
Surgical and medical procedures      
Wound Complication † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     2     0  
Vascular disorders      
Thrombosis/Thrombus/Embolism † 1    
# participants affected / at risk     2/38 (5.26%)     0/41 (0.00%)  
# events     13     0  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE (3.0)



  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: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


Publications:

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00405938     History of Changes
Other Study ID Numbers: SCRI BRE 86
Study First Received: November 28, 2006
Results First Received: January 11, 2013
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration