Trial Outcomes & Findings for Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer (NCT NCT00217672)
NCT ID: NCT00217672
Last Updated: 2020-08-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
From randomization until tumor progression
Results posted on
2020-08-05
Participant Flow
Recruitment period from March 2005 to September 2006 at academic medical clinics and community medical clinics.
Participant milestones
| Measure |
Docetaxel+Bevacizumab
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
Docetaxel
docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
|---|---|---|
|
Allocation
STARTED
|
69
|
7
|
|
Allocation
COMPLETED
|
67
|
7
|
|
Allocation
NOT COMPLETED
|
2
|
0
|
|
Treatment
STARTED
|
67
|
7
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
67
|
7
|
|
Follow-up
STARTED
|
74
|
0
|
|
Follow-up
COMPLETED
|
69
|
0
|
|
Follow-up
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Docetaxel+Bevacizumab
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
Docetaxel
docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
|---|---|---|
|
Allocation
Ineligible
|
2
|
0
|
|
Treatment
disease progression
|
33
|
4
|
|
Treatment
Adverse Event
|
18
|
2
|
|
Treatment
reqd treatment not permitted by protocol
|
6
|
0
|
|
Treatment
Physician Decision
|
6
|
0
|
|
Treatment
insurance issues
|
1
|
1
|
|
Treatment
Death
|
2
|
0
|
|
Treatment
secondary malignancy
|
1
|
0
|
|
Follow-up
Withdrawal by Subject
|
4
|
0
|
|
Follow-up
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel + Bevacizumab
n=67 Participants
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
A total of 104 participants were screened for the study. Twenty six participants did not meet eligibility criteria and 2 withdrew consent.
Seventy six participants were registered to the Treatment Period, 7 to arm A and 69 to arm B. Six out of 7 participants randomized to arm A elected to cross over to arm B once bevacizumab became available. Two out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. As a result, the efficacy analysis was performed on 67 patients.
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Hormone receptor status
Estrogen Receptor(ER)+ Progesterone Receptor(PR)+
|
29 participants
n=5 Participants
|
|
Hormone receptor status
ER+PR-
|
13 participants
n=5 Participants
|
|
Hormone receptor status
ER-PR+
|
3 participants
n=5 Participants
|
|
Hormone receptor status
ER-PR-
|
22 participants
n=5 Participants
|
|
Number of metastatic sites
less than 3
|
37 participants
n=5 Participants
|
|
Number of metastatic sites
more than 3
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until tumor progressionPopulation: 76 participants were registered to the Treatment, 7 to arm A and 69 to arm B. 6 participants randomized to arm A elected to cross over to arm B once Avastin became available. 2 out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. Thus, the efficacy analysis performed on 67 patients.
Outcome measures
| Measure |
Docetaxel + Bevacizumab
n=67 Participants
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
|---|---|
|
Antitumor Activity Based on Time to Tumor Progression (TTP).
|
9.3 months
Interval 8.2 to 12.4
|
SECONDARY outcome
Timeframe: Time of death, up to 3 yearsPopulation: Response rate - the percentage of patients assigned to a treatment arm who experience a CR or PR. Duration of response - the interval from date of initial documented response (CR or PR) to the first documented date of disease progression. Overall survival - the interval from the date of registration and the date of death.
Outcome measures
| Measure |
Docetaxel + Bevacizumab
n=67 Participants
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
|---|---|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
Overall Duration of Response (DR)
|
11.8 months
Interval 9.0 to 18.2
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
Overall Observed Response (OR)
|
26.3 months
Interval 20.8 to
NA is not reached for this entry.
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
ER+ and/or PgR+ DR
|
14.6 months
Interval 10.2 to 19.2
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
ER+ and/or PgR+ OR
|
NA months
Interval 25.3 to
end number was not reached (NR). not enough data NA is not reached for the confidence interval entry.
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
ER-/PgR- DR
|
6.2 months
Interval 4.2 to 10.6
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
ER-/PgR- OR
|
18.6 months
Interval 14.4 to 26.1
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
Adjuvantb Chemotherapy Including Taxane DR
|
18.2 months
Interval 7.2 to 23.6
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
Adjuvantb Chemotherapy Including Taxane OR
|
26.1 months
Interval 17.4 to
NA is not reached for this entry.
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
Adjuvantb Chemotherapy Without Taxane DR
|
13.2 months
Interval 10.2 to 15.7
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
Adjuvantb Chemotherapy Without Taxane OR
|
NA months
Interval 15.0 to
end number was not reached (NR). not enough data NA is not reached for the confidence interval entry.
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
No Previous Adjuvant Chemo DR
|
9.0 months
Interval 4.5 to 19.2
|
|
Comparison of Response Rates, Duration of Response, and Overall Survival
No Previous Adjuvant Chemo OR
|
26.3 months
Interval 22.1 to
NA is not reached for this entry.
|
SECONDARY outcome
Timeframe: When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of studyEvaluated using adverse event (AE) information. Detailed AE information is provided in the AE section.
Outcome measures
| Measure |
Docetaxel + Bevacizumab
n=76 Participants
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
|---|---|
|
Comparison of Safety and Toxicity
dose reduction of docetaxel for toxicity
|
10 subjects
|
|
Comparison of Safety and Toxicity
dose delay or interruption
|
19 subjects
|
|
Comparison of Safety and Toxicity
discontinued docetaxel and continued to receive be
|
10 subjects
|
|
Comparison of Safety and Toxicity
bevacizumab dose delay or interruption
|
24 subjects
|
|
Comparison of Safety and Toxicity
patients came off of study because of bevacizumab-
|
9 subjects
|
Adverse Events
Docetaxel and/or Bevacizumab
Serious events: 13 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel and/or Bevacizumab
n=74 participants at risk
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
|---|---|
|
Infections and infestations
Infection
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Infections and infestations
febrile neutropenia
|
4.1%
3/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Cardiac disorders
left ventricular dysfunction
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
fistula enterovesical
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Vascular disorders
hemorrhage/bleeding
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
constipation and hypokalemia
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
nausea, vomiting and burning abdominal pain
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Nervous system disorders
speech impairment
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Vascular disorders
pulmonary embolism
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea, pain
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
neutropenia
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
Other adverse events
| Measure |
Docetaxel and/or Bevacizumab
n=74 participants at risk
docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
|
|---|---|
|
General disorders
fever
|
4.1%
3/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
neutropenia
|
33.8%
25/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
leukopenia/lymphopenia
|
25.7%
19/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
febrile neuropenia
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
anemia
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
General disorders
fatigue
|
23.0%
17/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
General disorders
insomnia
|
4.1%
3/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
mucositis/esophagitis/dysphagia
|
8.1%
6/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
diarrhea
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
anorexia
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
nausea/vomiting
|
4.1%
3/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
dehydration
|
4.1%
3/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
colitis
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Infections and infestations
infection
|
17.6%
13/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
General disorders
pain
|
16.2%
12/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Cardiac disorders
hypertension
|
9.5%
7/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Vascular disorders
thromboembolism
|
4.1%
3/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Cardiac disorders
left ventricular dysfunction
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Metabolism and nutrition disorders
electrolyte abnormality/hyperglycemia
|
14.9%
11/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Nervous system disorders
neuropathy
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Nervous system disorders
syncope
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Nervous system disorders
other
|
8.1%
6/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Skin and subcutaneous tissue disorders
dermatology
|
5.4%
4/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea/hypoxia
|
5.4%
4/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Psychiatric disorders
mood alteration
|
8.1%
6/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
hemorrhage
|
4.1%
3/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
epistaxis
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Gastrointestinal disorders
hematemesis
|
1.4%
1/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Renal and urinary disorders
proteinuria
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
2.7%
2/74 • Adverse event (AE) data collected between 03/2005 and 11/2009. AE reporting period is 4 years 8 months.
Systemic adverse event assessment occurred every 21 days through investigator assessment during treatment period.
|
Additional Information
Sara Hurvitz, M.D.
University of California, Los Angeles
Phone: 310-829-5471
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place