Breast Cancer
Conditions
Brief summary
This observational study will assess the median time of treatment duration and the safety of Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data will be collected for approximately 24 months.
Interventions
DRUGBevacizumab
Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with metastatic breast cancer in first line treatment who have completed treatment with Avastin
Exclusion criteria
* Patients not willing or unable to signed written consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression (TDP) | Up to a maximum of 36.4 months | Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Duration: Number of Bevacizumab Cycles | Up to a maximum of 36.4 months | Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles. |
Countries
Argentina
Participant flow
Recruitment details
The study duration is January 2010 (first data collected) to July 2012 (last data collected). In this study, medical records of participants evaluated between 2008 and 2012 were reviewed.
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Bevacizumab |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 28 |
| serious Total, serious adverse events | 10 / 28 |
Outcome results
Primary
Time to Disease Progression (TDP)
Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 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.
Time frame: Up to a maximum of 36.4 months
Population: All enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Time to Disease Progression (TDP) | 15.3 months |
Secondary
Treatment Duration: Number of Bevacizumab Cycles
Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.
Time frame: Up to a maximum of 36.4 months
Population: All enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Treatment Duration: Number of Bevacizumab Cycles | 6 cycles |