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Trial record 34 of 264 for:    Estrogen Resistance

Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Previously Hormone Responsive Metastatic Breast Ca.

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ClinicalTrials.gov Identifier: NCT00240071
Recruitment Status : Completed
First Posted : October 17, 2005
Results First Posted : September 27, 2011
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Carla Falkson, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Avastin
Drug: Hormonal therapy
Enrollment 30
Recruitment Details Recruitment started October 2005 - until March 2009. Kirklin Clinic at UAB, Birmingham AL and Georgia Cancer Center, Atlanta GA
Pre-assignment Details The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin.
Arm/Group Title Avastin(Bevacizumab) Plus Hormonal Therapy
Hide Arm/Group Description Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
Period Title: Overall Study
Started 30
Completed 27 [1]
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
[1]
3 patients withdrew consent after 29, 5 and 3 1/2 months on study.
Arm/Group Title Avastin(Bevacizumab) Plus Hormonal Therapy
Hide Arm/Group Description Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  63.3%
>=65 years
11
  36.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
59.7  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.
Time Frame From date of registration until disease progression or death, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
All participants entered onto study (intention to treat) (ITT) were analyzed.
Arm/Group Title Avastin (Bevacizumab) Plus Hormone
Hide Arm/Group Description:
All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: days
125.5
(90 to 256)
2.Secondary Outcome
Title The Secondary Efficacy Outcome Will be Objective Response Rate (Defined as the Rate of Complete and Partial Responses.
Hide Description [Not Specified]
Time Frame Determined on two consecutive occasions at least 4 weeks apart.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Avastin
Hide Arm/Group Description:

The patient will continue the same hormonal therapy used prior to study enrollment but will combine it with Avastin.

Avastin: All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.

Hormonal therapy: aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or SERM (tamoxifen 20mg/d PO)

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
0
Time Frame 1245 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Avastin(Bevacizumab) Plus Hormonal Therapy
Hide Arm/Group Description Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
All-Cause Mortality
Avastin(Bevacizumab) Plus Hormonal Therapy
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Avastin(Bevacizumab) Plus Hormonal Therapy
Affected / at Risk (%)
Total   7/30 (23.33%) 
Gastrointestinal disorders   
Grade III diarrhea *  1/30 (3.33%) 
General disorders   
Grade III fatigue *  2/30 (6.67%) 
Grade III syncope *  2/30 (6.67%) 
Metabolism and nutrition disorders   
Hyperkalemia *  1/30 (3.33%) 
Musculoskeletal and connective tissue disorders   
Knee and foot pain *  1/30 (3.33%) 
Nervous system disorders   
Grade III neuropathy *  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Grade III dyspnea on exertion *  2/30 (6.67%) 
Skin and subcutaneous tissue disorders   
Grade III leg ulcer   1/30 (3.33%) 
Vascular disorders   
Grade III hypertension   4/30 (13.33%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Avastin(Bevacizumab) Plus Hormonal Therapy
Affected / at Risk (%)
Total   24/30 (80.00%) 
Blood and lymphatic system disorders   
Anemia   2/30 (6.67%) 
Ear and labyrinth disorders   
Epistaxis *  4/30 (13.33%) 
Dizziness *  2/30 (6.67%) 
Gastrointestinal disorders   
Diarrhea *  3/30 (10.00%) 
Transaminitits   4/30 (13.33%) 
Nausea and vomiting *  8/30 (26.67%) 
GI Bleeding *  2/30 (6.67%) 
Mucositis *  4/30 (13.33%) 
Change in taste *  2/30 (6.67%) 
General disorders   
Fatigue *  6/30 (20.00%) 
Anorexia *  2/30 (6.67%) 
Weight loss   4/30 (13.33%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain *  7/30 (23.33%) 
Arthralgias *  2/30 (6.67%) 
Nervous system disorders   
Headache *  2/30 (6.67%) 
Renal and urinary disorders   
Proteinuria   10/30 (33.33%) 
Acute Renal Failure   2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Hoarsness of voice *  3/30 (10.00%) 
Cough *  3/30 (10.00%) 
Skin and subcutaneous tissue disorders   
Skin rash *  2/30 (6.67%) 
Vascular disorders   
Hypertension   4/30 (13.33%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carla I Falkson
Organization: University of Alabama at Birmingham
Phone: 205-975-2691
EMail: cfalkson@uab.edu
Layout table for additonal information
Responsible Party: Carla Falkson, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00240071     History of Changes
Other Study ID Numbers: F050103001
UAB 0461 ( Other Identifier: institutional protocol study number )
First Submitted: October 13, 2005
First Posted: October 17, 2005
Results First Submitted: April 20, 2011
Results First Posted: September 27, 2011
Last Update Posted: March 19, 2018