Trial Outcomes & Findings for Study of Avastin (Bevacizumab) to Reverse Acquired Estrogen Independence in Previously Hormone Responsive Metastatic Breast Ca. (NCT NCT00240071)

NCT ID: NCT00240071

Last Updated: 2019-10-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: From date of registration until disease progression or death, whichever occurs first
• Results posted on: 2019-10-30

Participant Flow

Recruitment started October 2005 - until March 2009. Kirklin Clinic at University of Alabama at Birmingham (UAB), Birmingham, Alabama (AL) and Georgia Cancer Center, Atlanta, Georgia (GA)

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.

Participant milestones

Measure	Avastin(Bevacizumab) Plus Hormonal Therapy Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Avastin(Bevacizumab) Plus Hormonal Therapy Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Avastin(Bevacizumab) Plus Hormonal Therapy n=30 Participants Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	59.7 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: From date of registration until disease progression or death, whichever occurs first

Population: All participants entered onto study (intention to treat) (ITT) were analyzed.

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.

Outcome measures

Measure	Avastin (Bevacizumab) Plus Hormone n=30 Participants All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
Progression Free Survival (PFS)	125.5 days Interval 90.0 to 256.0

SECONDARY outcome

Timeframe: From date of registration until disease progression or death, whichever occurs first

Outcome measures

Measure	Avastin (Bevacizumab) Plus Hormone n=30 Participants All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
Objective Response Rate (Defined as the Rate of Complete and Partial Responses).	0 participants

Adverse Events

Avastin(Bevacizumab) Plus Hormonal Therapy

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Avastin(Bevacizumab) Plus Hormonal Therapy n=30 participants at risk Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
Gastrointestinal disorders Grade III diarrhea	3.3% 1/30 • 1245 days
Skin and subcutaneous tissue disorders Grade III leg ulcer	3.3% 1/30 • 1245 days
General disorders Grade III fatigue	6.7% 2/30 • 1245 days
Vascular disorders Grade III hypertension	13.3% 4/30 • 1245 days
Nervous system disorders Grade III neuropathy	3.3% 1/30 • 1245 days
General disorders Grade III syncope	6.7% 2/30 • 1245 days
Musculoskeletal and connective tissue disorders Knee and foot pain	3.3% 1/30 • 1245 days
Metabolism and nutrition disorders Hyperkalemia	3.3% 1/30 • 1245 days
Respiratory, thoracic and mediastinal disorders Grade III dyspnea on exertion	6.7% 2/30 • 1245 days

Other adverse events

Measure	Avastin(Bevacizumab) Plus Hormonal Therapy n=30 participants at risk Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
Renal and urinary disorders Proteinuria	33.3% 10/30 • 1245 days
Gastrointestinal disorders Diarrhea	10.0% 3/30 • 1245 days
Respiratory, thoracic and mediastinal disorders Hoarsness of voice	10.0% 3/30 • 1245 days
Gastrointestinal disorders Transaminitits	13.3% 4/30 • 1245 days
General disorders Fatigue	20.0% 6/30 • 1245 days
Vascular disorders Hypertension	13.3% 4/30 • 1245 days
Gastrointestinal disorders Nausea and vomiting	26.7% 8/30 • 1245 days
Musculoskeletal and connective tissue disorders Musculoskeletal pain	23.3% 7/30 • 1245 days
Respiratory, thoracic and mediastinal disorders Cough	10.0% 3/30 • 1245 days
Ear and labyrinth disorders Epistaxis	13.3% 4/30 • 1245 days
Gastrointestinal disorders GI Bleeding	6.7% 2/30 • 1245 days
Renal and urinary disorders Acute Renal Failure	6.7% 2/30 • 1245 days
Ear and labyrinth disorders Dizziness	6.7% 2/30 • 1245 days
General disorders Anorexia	6.7% 2/30 • 1245 days
General disorders Weight loss	13.3% 4/30 • 1245 days
Blood and lymphatic system disorders Anemia	6.7% 2/30 • 1245 days
Gastrointestinal disorders Mucositis	13.3% 4/30 • 1245 days
Gastrointestinal disorders Change in taste	6.7% 2/30 • 1245 days
Skin and subcutaneous tissue disorders Skin rash	6.7% 2/30 • 1245 days
Nervous system disorders Headache	6.7% 2/30 • 1245 days
Musculoskeletal and connective tissue disorders Arthralgias	6.7% 2/30 • 1245 days

Additional Information

Carla I Falkson

University of Alabama at Birmingham

Phone: 205-975-2691

Email: cfalkson@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place