Trial Outcomes & Findings for Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients (NCT NCT00428922)
NCT ID: NCT00428922
Last Updated: 2018-08-09
Results Overview
The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.
COMPLETED
PHASE2
26 participants
up to 3 years
2018-08-09
Participant Flow
September 2007 and November 2012
Participant milestones
| Measure |
Trastuzumab, Bevacizumab, and Docetaxel
Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients
Baseline characteristics by cohort
| Measure |
Trastuzumab, Bevacizumab, and Docetaxel
n=26 Participants
Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 patients
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsThe trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.
Outcome measures
| Measure |
Trastuzumab, Bevacizumab, and Docetaxel
n=26 Participants
Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]
|
|---|---|
|
Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.
|
14.3 months
Interval 9.3 to 35.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 22Population: Due to sample size, could not perform any statistical analysis to correlate the baseline CTCs with PFS and response rate. Samples only available for 50% of the patients.
Circulating tumor cells (CTCs) evaluated at baseline (day 1 of treatment) and after 1 treatment cycle (day 22 prior to cycle 2 treatment).
Outcome measures
| Measure |
Trastuzumab, Bevacizumab, and Docetaxel
n=13 Participants
Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]
|
|---|---|
|
Changes in CTCs as Predictors of PFS and Clinical Benefit
|
7 patients with detected CTCs
|
SECONDARY outcome
Timeframe: at least 24 weeksDefined as best response of CR or PR or stable disease for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Outcome measures
| Measure |
Trastuzumab, Bevacizumab, and Docetaxel
n=26 Participants
Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]
|
|---|---|
|
Overall Clinical Benefit Rate (CR+PR+SD)
|
69 percent of patients
Interval 48.0 to 86.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 22Population: CEC data was not collected and available for analysis
Circulating endothelial cells (CECs) are to be collected day 1 prior to treatment and day 22 prior to treatment. These samples are to be collected at the PI's discretion based upon the availability of the cell processing laboratory, the patients will be informed when consented if the samples will collected or not.
Outcome measures
Outcome data not reported
Adverse Events
Trastuzumab, Bevacizumab, and Docetaxel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trastuzumab, Bevacizumab, and Docetaxel
n=26 participants at risk
Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
42.3%
11/26 • Number of events 11
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
General disorders
Neutropenia
|
15.4%
4/26 • Number of events 4
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.7%
2/26 • Number of events 2
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
General disorders
Fever without neutropenia
|
30.8%
8/26 • Number of events 8
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Infections and infestations
Infection
|
92.3%
24/26 • Number of events 24
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
General disorders
Fatigue
|
92.3%
24/26 • Number of events 24
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
80.8%
21/26 • Number of events 21
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
73.1%
19/26 • Number of events 19
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Gastrointestinal disorders
Abdominal Pain
|
46.2%
12/26 • Number of events 12
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Gastrointestinal disorders
Constipation
|
46.2%
12/26 • Number of events 12
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
73.1%
19/26 • Number of events 19
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Gastrointestinal disorders
Nausea
|
69.2%
18/26 • Number of events 18
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Gastrointestinal disorders
Vomiting
|
53.8%
14/26 • Number of events 14
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.3%
11/26 • Number of events 11
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
34.6%
9/26 • Number of events 9
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Cardiac disorders
decreased LVEF
|
11.5%
3/26 • Number of events 3
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Vascular disorders
Hypertension
|
26.9%
7/26 • Number of events 7
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
61.5%
16/26 • Number of events 16
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Nervous system disorders
Headaches
|
57.7%
15/26 • Number of events 15
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Eye disorders
Vision changes
|
46.2%
12/26 • Number of events 12
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Renal and urinary disorders
Proteinuria
|
11.5%
3/26 • Number of events 3
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
84.6%
22/26 • Number of events 22
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Wound Complication
|
7.7%
2/26 • Number of events 2
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Gastrointestinal disorders
Mucositis
|
73.1%
19/26 • Number of events 19
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
|
Eye disorders
Increased lacrimation
|
46.2%
12/26 • Number of events 12
NCI Common Toxicity Criteria (CTC) version 3.0 was utilize the CTC for adverse event reporting.
|
Additional Information
Bhuvaneswari Ramaswamy, MD
The Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place