Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
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
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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/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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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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 (100.00%)   41/41 (100.00%) 
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)



  Limitations and Caveats
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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
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