Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00281697
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : September 24, 2012
Last Update Posted : July 26, 2013
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Bevacizumab
Drug: Placebo
Drug: Standard chemotherapy
Enrollment 684
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen. Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Period Title: Overall Study
Started 459 225
Completed 58 28
Not Completed 401 197
Reason Not Completed
> 60 days since last dose of study drug             4             4
Adverse Event             54             15
Death             8             3
Disease progression             279             149
Other             5             6
Physician's decision to withdraw             15             12
Subject/guardian's decision to withdraw             33             6
Did not receive study drug             3             2
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo Total
Hide Arm/Group Description Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen. Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen. Total of all reporting groups
Overall Number of Baseline Participants 459 225 684
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 459 participants 225 participants 684 participants
55.6  (11.0) 55.0  (11.2) 55.4  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 459 participants 225 participants 684 participants
Female
457
  99.6%
225
 100.0%
682
  99.7%
Male
2
   0.4%
0
   0.0%
2
   0.3%
1.Primary Outcome
Title Progression-free Survival
Hide Description PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Time Frame Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description:
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Overall Number of Participants Analyzed 459 225
Median (95% Confidence Interval)
Unit of Measure: Months
7.2
(6.5 to 7.6)
5.1
(4.1 to 6.0)
2.Secondary Outcome
Title Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)
Hide Description Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. Results are reported for each of the 4 standard chemotherapy cohorts used in the study.
Time Frame Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description:
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Overall Number of Participants Analyzed 459 225
Median (95% Confidence Interval)
Unit of Measure: Months
Taxanes, n=201, 103
8.0
(7.2 to 9.3)
5.8
(4.2 to 7.9)
Gemcitabine, n=108, 52
6.0
(5.5 to 7.1)
5.5
(2.6 to 7.5)
Capecitabine, n=97, 47
6.9
(5.5 to 8.5)
4.1
(2.8 to 5.1)
Vinorelbine, n=53, 23
5.7
(3.5 to 7.5)
7.0
(2.7 to 8.9)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization to death from any cause.
Time Frame Baseline to the end of the study (up to 6 years, 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description:
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Overall Number of Participants Analyzed 459 225
Median (95% Confidence Interval)
Unit of Measure: Months
18.6
(17.4 to 20.0)
17.8
(15.1 to 20.4)
4.Secondary Outcome
Title One-year Survival
Hide Description Percentage of patients who survived 1 year in the study.
Time Frame Baseline to the end of the study (up to 6 years, 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description:
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Overall Number of Participants Analyzed 459 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
70.5
(66.3 to 74.7)
68.6
(62.5 to 74.8)
5.Secondary Outcome
Title Objective Response
Hide Description A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Time Frame Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline were included in the analysis.
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description:
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Overall Number of Participants Analyzed 362 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
39.5
(34.4 to 44.7)
29.6
(23.0 to 36.7)
6.Secondary Outcome
Title Duration of Objective Response
Hide Description Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first. Duration of objective response was only analyzed in patients who achieved an objective response.
Time Frame Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline and achieved an objective response were included in the analysis.
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description:
Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
Overall Number of Participants Analyzed 143 53
Median (95% Confidence Interval)
Unit of Measure: Months
7.3
(6.2 to 8.2)
7.5
(6.6 to 9.2)
Time Frame Adverse events were collected from Baseline to the end of the study (up to 6 years, 7 months).
Adverse Event Reporting Description Adverse events are reported for safety-evaluable population defined as all randomized patients who received study treatment, defined as at least 1 full or partial dose of bevacizumab, placebo, or standard chemotherapy.
 
Arm/Group Title Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Hide Arm/Group Description Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen. Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
All-Cause Mortality
Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   112/458 (24.45%)   39/221 (17.65%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  8/458 (1.75%)  5/221 (2.26%) 
Neutropenia  1  6/458 (1.31%)  1/221 (0.45%) 
Anaemia  1  3/458 (0.66%)  2/221 (0.90%) 
Thrombocytopenia  1  3/458 (0.66%)  0/221 (0.00%) 
Pancytopenia  1  2/458 (0.44%)  0/221 (0.00%) 
Cardiac disorders     
Myocardial infarction  1  0/458 (0.00%)  2/221 (0.90%) 
Pericardial effusion  1  0/458 (0.00%)  2/221 (0.90%) 
Tachycardia  1  0/458 (0.00%)  2/221 (0.90%) 
Acute myocardial infarction  1  1/458 (0.22%)  0/221 (0.00%) 
Atrial fibrillation  1  0/458 (0.00%)  1/221 (0.45%) 
Cardiac failure congestive  1  1/458 (0.22%)  1/221 (0.45%) 
Supraventricular tachycardia  1  0/458 (0.00%)  1/221 (0.45%) 
Eye disorders     
Diplopia  1  1/458 (0.22%)  0/221 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  6/458 (1.31%)  1/221 (0.45%) 
Nausea  1  4/458 (0.87%)  1/221 (0.45%) 
Constipation  1  3/458 (0.66%)  1/221 (0.45%) 
Diarrhoea  1  2/458 (0.44%)  1/221 (0.45%) 
Gastrointestinal haemorrhage  1  3/458 (0.66%)  0/221 (0.00%) 
Gastric ulcer  1  1/458 (0.22%)  1/221 (0.45%) 
Lower gastrointestinal haemorrhage  1  2/458 (0.44%)  0/221 (0.00%) 
Oesophagitis  1  1/458 (0.22%)  1/221 (0.45%) 
Periproctitis  1  2/458 (0.44%)  0/221 (0.00%) 
Abdominal pain  1  1/458 (0.22%)  0/221 (0.00%) 
Abdominal pain lower  1  1/458 (0.22%)  0/221 (0.00%) 
Abdominal pain upper  1  0/458 (0.00%)  1/221 (0.45%) 
Colitis  1  1/458 (0.22%)  0/221 (0.00%) 
Enterovesical fistula  1  1/458 (0.22%)  0/221 (0.00%) 
Gastritis  1  1/458 (0.22%)  0/221 (0.00%) 
Gastrointestinal perforation  1  1/458 (0.22%)  0/221 (0.00%) 
Haematemesis  1  1/458 (0.22%)  0/221 (0.00%) 
Ileus  1  1/458 (0.22%)  0/221 (0.00%) 
Intestinal perforation  1  1/458 (0.22%)  0/221 (0.00%) 
Obstruction gastric  1  0/458 (0.00%)  1/221 (0.45%) 
Odynophagia  1  1/458 (0.22%)  0/221 (0.00%) 
Oesophageal varices haemorrhage  1  1/458 (0.22%)  0/221 (0.00%) 
Proctitis  1  1/458 (0.22%)  0/221 (0.00%) 
Small intestinal obstruction  1  1/458 (0.22%)  0/221 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/458 (0.22%)  0/221 (0.00%) 
General disorders     
Pyrexia  1  3/458 (0.66%)  2/221 (0.90%) 
Asthenia  1  1/458 (0.22%)  1/221 (0.45%) 
Chest pain  1  1/458 (0.22%)  1/221 (0.45%) 
Thrombosis in device  1  1/458 (0.22%)  0/221 (0.00%) 
Death  1  0/458 (0.00%)  1/221 (0.45%) 
Impaired healing  1  1/458 (0.22%)  0/221 (0.00%) 
Oedema peripheral  1  0/458 (0.00%)  1/221 (0.45%) 
Pain  1  1/458 (0.22%)  0/221 (0.00%) 
Performance status decreased  1  1/458 (0.22%)  0/221 (0.00%) 
Sudden death  1  0/458 (0.00%)  1/221 (0.45%) 
Device dislocation  1  1/458 (0.22%)  0/221 (0.00%) 
Hepatobiliary disorders     
Hepatitis  1  1/458 (0.22%)  0/221 (0.00%) 
Hepatitis cholestatic  1  1/458 (0.22%)  0/221 (0.00%) 
Hyperbilirubinaemia  1  1/458 (0.22%)  0/221 (0.00%) 
Infections and infestations     
Pneumonia  1  3/458 (0.66%)  3/221 (1.36%) 
Infection  1  4/458 (0.87%)  0/221 (0.00%) 
Cellulitis  1  2/458 (0.44%)  1/221 (0.45%) 
Urinary tract infection  1  0/458 (0.00%)  3/221 (1.36%) 
Bronchitis  1  2/458 (0.44%)  0/221 (0.00%) 
Herpes zoster  1  2/458 (0.44%)  0/221 (0.00%) 
Lower respiratory tract infection  1  1/458 (0.22%)  1/221 (0.45%) 
Septic shock  1  0/458 (0.00%)  1/221 (0.45%) 
Appendicitis  1  1/458 (0.22%)  0/221 (0.00%) 
Bronchopneumonia  1  1/458 (0.22%)  0/221 (0.00%) 
Device related infection  1  1/458 (0.22%)  0/221 (0.00%) 
Erysipelas  1  1/458 (0.22%)  0/221 (0.00%) 
Escherichia bacteraemia  1  0/458 (0.00%)  1/221 (0.45%) 
Gastroenteritis  1  1/458 (0.22%)  0/221 (0.00%) 
Neutropenic infection  1  0/458 (0.00%)  1/221 (0.45%) 
Neutropenic sepsis  1  0/458 (0.00%)  1/221 (0.45%) 
Rectal abscess  1  1/458 (0.22%)  0/221 (0.00%) 
Subcutaneous abscess  1  1/458 (0.22%)  0/221 (0.00%) 
Lobar pneumonia  1  0/458 (0.00%)  1/221 (0.45%) 
Injury, poisoning and procedural complications     
Hip fracture  1  3/458 (0.66%)  0/221 (0.00%) 
Post procedural haemorrhage  1  1/458 (0.22%)  0/221 (0.00%) 
Skull fracture  1  1/458 (0.22%)  0/221 (0.00%) 
Spinal compression fracture  1  1/458 (0.22%)  0/221 (0.00%) 
Wrist fracture  1  1/458 (0.22%)  0/221 (0.00%) 
Investigations     
Platelet count decreased  1  1/458 (0.22%)  0/221 (0.00%) 
Troponin increased  1  1/458 (0.22%)  0/221 (0.00%) 
Electrocardiogram abnormal  1  0/458 (0.00%)  1/221 (0.45%) 
Metabolism and nutrition disorders     
Dehydration  1  5/458 (1.09%)  0/221 (0.00%) 
Failure to thrive  1  1/458 (0.22%)  1/221 (0.45%) 
Hypoglycaemia  1  1/458 (0.22%)  0/221 (0.00%) 
Hypovolaemia  1  1/458 (0.22%)  0/221 (0.00%) 
Metabolic acidosis  1  0/458 (0.00%)  1/221 (0.45%) 
Hyperglycaemia  1  0/458 (0.00%)  1/221 (0.45%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  3/458 (0.66%)  0/221 (0.00%) 
Bone pain  1  2/458 (0.44%)  0/221 (0.00%) 
Musculoskeletal pain  1  2/458 (0.44%)  0/221 (0.00%) 
Pathological fracture  1  2/458 (0.44%)  0/221 (0.00%) 
Arthropathy  1  1/458 (0.22%)  0/221 (0.00%) 
Fascitis  1  1/458 (0.22%)  0/221 (0.00%) 
Muscle twitching  1  0/458 (0.00%)  1/221 (0.45%) 
Muscular weakness  1  1/458 (0.22%)  0/221 (0.00%) 
Myopathy  1  0/458 (0.00%)  1/221 (0.45%) 
Pain in extremity  1  0/458 (0.00%)  1/221 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to meninges  1  2/458 (0.44%)  0/221 (0.00%) 
Metastases to central nervous system  1  1/458 (0.22%)  0/221 (0.00%) 
Tumour haemorrhage  1  0/458 (0.00%)  1/221 (0.45%) 
Tumour necrosis  1  1/458 (0.22%)  0/221 (0.00%) 
Nervous system disorders     
Syncope  1  2/458 (0.44%)  0/221 (0.00%) 
Tremor  1  1/458 (0.22%)  1/221 (0.45%) 
Altered state of consciousness  1  1/458 (0.22%)  0/221 (0.00%) 
Cerebral ischaemia  1  0/458 (0.00%)  1/221 (0.45%) 
Convulsion  1  1/458 (0.22%)  0/221 (0.00%) 
Cranial nerve paralysis  1  0/458 (0.00%)  1/221 (0.45%) 
Headache  1  1/458 (0.22%)  0/221 (0.00%) 
Neuropathy peripheral  1  1/458 (0.22%)  0/221 (0.00%) 
Transient ischaemic attack  1  1/458 (0.22%)  0/221 (0.00%) 
Psychiatric disorders     
Mental status changes  1  1/458 (0.22%)  1/221 (0.45%) 
Conversion disorder  1  1/458 (0.22%)  0/221 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  3/458 (0.66%)  1/221 (0.45%) 
Nephrotic syndrome  1  1/458 (0.22%)  0/221 (0.00%) 
Proteinuria  1  1/458 (0.22%)  0/221 (0.00%) 
Renal tubular necrosis  1  0/458 (0.00%)  1/221 (0.45%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  1/458 (0.22%)  0/221 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/458 (0.44%)  3/221 (1.36%) 
Pulmonary embolism  1  3/458 (0.66%)  2/221 (0.90%) 
Pleural effusion  1  3/458 (0.66%)  1/221 (0.45%) 
Hypoxia  1  1/458 (0.22%)  1/221 (0.45%) 
Acute pulmonary oedema  1  0/458 (0.00%)  1/221 (0.45%) 
Acute respiratory distress syndrome  1  1/458 (0.22%)  0/221 (0.00%) 
Asthma  1  0/458 (0.00%)  2/221 (0.90%) 
Haemoptysis  1  1/458 (0.22%)  0/221 (0.00%) 
Pulmonary oedema  1  0/458 (0.00%)  1/221 (0.45%) 
Respiratory failure  1  1/458 (0.22%)  0/221 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/458 (0.00%)  1/221 (0.45%) 
Vascular disorders     
Deep vein thrombosis  1  4/458 (0.87%)  1/221 (0.45%) 
Hypertension  1  2/458 (0.44%)  0/221 (0.00%) 
Hypertensive crisis  1  1/458 (0.22%)  0/221 (0.00%) 
Hypotension  1  1/458 (0.22%)  0/221 (0.00%) 
Superior vena caval syndrome  1  1/458 (0.22%)  0/221 (0.00%) 
Thrombosis  1  1/458 (0.22%)  0/221 (0.00%) 
Embolism  1  1/458 (0.22%)  0/221 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Chemotherapy + Bevacizumab Standard Chemotherapy + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   125/458 (27.29%)   39/221 (17.65%) 
Blood and lymphatic system disorders     
Neutropenia  1  77/458 (16.81%)  33/221 (14.93%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  25/458 (5.46%)  9/221 (4.07%) 
Vascular disorders     
Hypertension  1  37/458 (8.08%)  1/221 (0.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800 821-8590
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00281697    
Other Study ID Numbers: AVF3693g
First Submitted: January 23, 2006
First Posted: January 25, 2006
Results First Submitted: August 23, 2012
Results First Posted: September 24, 2012
Last Update Posted: July 26, 2013