Breast Cancer
Conditions
Brief summary
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m\^2 iv, and gemcitabine 200 mg/m\^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.
Interventions
DRUGBevacizumab
Bevacizumab was supplied as a sterile liquid in glass vials.
DRUGPaclitaxel
Paclitaxel was supplied as a sterile liquid in glass vials.
DRUGGemcitabine
Gemcitabine was supplied as a sterile liquid in glass vials.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients, ≥ 18 years of age. * Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only. * HER-2 negative disease. * Candidates for chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion criteria
* Previous chemotherapy for metastatic or locally advanced breast cancer. * Previous radiotherapy for treatment of metastatic breast cancer. * Any prior adjuvant treatment with anthracyclines completed \< 6 months prior to enrollment. * Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (\> 325 mg/day) or clopidogrel (\> 75mg/day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Baseline to the end of the study (up to 2 years 10 months) | Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Objective Response | Baseline to the end of the study (up to 2 years 10 months) | An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. |
| Duration of the Objective Response | Baseline to the end of the study (up to 2 years 10 months) | Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease. |
| Overall Survival | Baseline to the end of the study (up to 2 years 10 months) | Overall survival is defined as the time from the first dose of study medication until death. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab + Paclitaxel + Gemcitabine Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Disease Progression | 30 |
| Overall Study | Investigator Discretion | 29 |
| Overall Study | Patient Decision | 7 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Subject Not Treated | 7 |
| Overall Study | Toxicity | 12 |
Baseline characteristics
| Characteristic | Bevacizumab + Paclitaxel + Gemcitabine |
|---|---|
| Age, Continuous | 52.20 years STANDARD_DEVIATION 12.48 |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 82 / 82 |
| serious Total, serious adverse events | 21 / 82 |
Outcome results
Primary
Progression-free Survival
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Time frame: Baseline to the end of the study (up to 2 years 10 months)
Population: Intent-to-treat population: All participants who were enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Paclitaxel + Gemcitabine | Progression-free Survival | 11.51 Months |
Secondary
Duration of the Objective Response
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Time frame: Baseline to the end of the study (up to 2 years 10 months)
Population: Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Paclitaxel + Gemcitabine | Duration of the Objective Response | 12.39 Months |
Secondary
Overall Survival
Overall survival is defined as the time from the first dose of study medication until death.
Time frame: Baseline to the end of the study (up to 2 years 10 months)
Population: Intent-to-treat population: All participants who were enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Paclitaxel + Gemcitabine | Overall Survival | 27.39 Months |
Secondary
Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Time frame: Baseline to the end of the study (up to 2 years 10 months)
Population: Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Paclitaxel + Gemcitabine | Percentage of Participants With an Objective Response | 72.37 Percentage of participants |