Metastatic Breast Cancer
Conditions
Brief summary
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.
Interventions
DRUGBevacizumab [Avastin]
Intravenous repeating dose
DRUGPaclitaxel
Intravenous repeating dose
DRUGPlacebo
Intravenous repeating dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent. * ECOG performance status of 0 or 1 * For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception * For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization
Exclusion criteria
Disease-Specific Exclusions: * HER2-positive status * Prior chemotherapy for locally recurrent or metastatic disease * Prior hormonal therapy \< 2 weeks prior to randomization * Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization * Investigational therapy within 28 days of randomization General Medical Exclusions: * Life expectancy of \< 12 weeks * Inadequate organ function * Uncontrolled serious medical or psychiatric illness * Active infection requiring intravenous (IV) antibiotics at screening * Pregnancy or lactation * History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population | Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks) | Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions. |
| Progression Free Survival (PFS) in ITT Population | Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks) | PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. |
| Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population | Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks) | Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. |
| PFS in High Baseline Plasma VEGF-A ITT Population | Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks) | PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Objective Response - ITT Population | Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks) | Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI). |
| Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population | Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks) | Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI. |
| Duration of Response - ITT Population | Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks) | Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method. |
| Percentage of Participants Who Died - ITT Population | From randomization till death or clinical cut-off (up to 244 weeks) | — |
| Percentage of Participants Who Were Alive at 1 Year - ITT Population | 1 year | — |
| Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population | 1 year | — |
| Duration of Response - High Baseline Plasma VEGF-A ITT Population | Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks) | Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method. |
| Overall Survival (OS) - ITT Population | From randomization till death or clinical cut-off (up to 244 weeks) | OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method. |
| Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population | From randomization till death or clinical cut-off (up to 244 weeks) | — |
| OS - High Baseline Plasma VEGF-A ITT Population | From randomization till death or clinical cut-off (up to 244 weeks) | OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method. |
Countries
Argentina, Belgium, Brazil, Bulgaria, Chile, Germany, Italy, Japan, Panama, Romania, Russia, South Africa, South Korea, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel+Placebo Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. | 242 |
| Paclitaxel+ Bevacizumab Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. | 239 |
| Total | 481 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 161 | 155 |
| Overall Study | Lost to Follow-up | 10 | 8 |
| Overall Study | Study Terminated | 51 | 50 |
| Overall Study | Withdrawal by Subject | 18 | 25 |
| Overall Study | Withdrawal by subject and Adverse Event. | 1 | 0 |
| Overall Study | Withdrawal prior to dosing. | 1 | 0 |
Baseline characteristics
| Characteristic | Paclitaxel+Placebo | Paclitaxel+ Bevacizumab | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10.7 | 55.8 years STANDARD_DEVIATION 11.5 | 55.3 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 237 Participants | 236 Participants | 473 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 162 / 233 | 161 / 238 |
| other Total, other adverse events | 225 / 233 | 230 / 238 |
| serious Total, serious adverse events | 45 / 233 | 66 / 238 |
Outcome results
Primary
Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population
Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.
Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Population: High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population | 75.0 percentage of participants |
| Paclitaxel+ Bevacizumab | Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population | 70.8 percentage of participants |
Primary
Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population
Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.
Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population | 69.4 percentage of participants |
| Paclitaxel+ Bevacizumab | Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population | 63.6 percentage of participants |
Primary
PFS in High Baseline Plasma VEGF-A ITT Population
PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Population: High baseline plasma VEGF-A ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel+Placebo | PFS in High Baseline Plasma VEGF-A ITT Population | 7.3 months |
| Paclitaxel+ Bevacizumab | PFS in High Baseline Plasma VEGF-A ITT Population | 9.6 months |
Comparison: Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).p-value: 0.003896% CI: [0.47, 0.88]Log Rank
Comparison: Unstratified analysis.p-value: 0.010196% CI: [0.5, 0.93]Log Rank
Primary
Progression Free Survival (PFS) in ITT Population
PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel+Placebo | Progression Free Survival (PFS) in ITT Population | 8.8 months |
| Paclitaxel+ Bevacizumab | Progression Free Survival (PFS) in ITT Population | 11.0 months |
Comparison: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).p-value: 0.000799% CI: [0.51, 0.91]Log Rank
Comparison: Unstratified Analysis.p-value: 0.004699% CI: [0.55, 0.97]Log Rank
Comparison: A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.p-value: 0.4619Wald Test
Secondary
Duration of Response - High Baseline Plasma VEGF-A ITT Population
Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.
Time frame: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)
Population: Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel+Placebo | Duration of Response - High Baseline Plasma VEGF-A ITT Population | 7.2 months |
| Paclitaxel+ Bevacizumab | Duration of Response - High Baseline Plasma VEGF-A ITT Population | 8.1 months |
Comparison: Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).p-value: 0.178395% CI: [0.41, 1.18]Log Rank
Comparison: Unstratified analysis.p-value: 0.242995% CI: [0.45, 1.22]Log Rank
Secondary
Duration of Response - ITT Population
Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.
Time frame: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)
Population: Number of participants analyzed=participants from ITT population who had an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel+Placebo | Duration of Response - ITT Population | 9.2 months |
| Paclitaxel+ Bevacizumab | Duration of Response - ITT Population | 9.5 months |
Comparison: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).p-value: 0.273795% CI: [0.54, 1.19]Log Rank
Comparison: Unstratified analysis.p-value: 0.295995% CI: [0.56, 1.19]Log Rank
Secondary
OS - High Baseline Plasma VEGF-A ITT Population
OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
Time frame: From randomization till death or clinical cut-off (up to 244 weeks)
Population: High Baseline Plasma VEGF-A ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel+Placebo | OS - High Baseline Plasma VEGF-A ITT Population | 19.4 months |
| Paclitaxel+ Bevacizumab | OS - High Baseline Plasma VEGF-A ITT Population | 22.8 months |
Comparison: Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).p-value: 0.274595% CI: [0.63, 1.14]Log Rank
Comparison: Unstratified analysis.p-value: 0.361695% CI: [0.65, 1.17]Log Rank
Secondary
Overall Survival (OS) - ITT Population
OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
Time frame: From randomization till death or clinical cut-off (up to 244 weeks)
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel+Placebo | Overall Survival (OS) - ITT Population | 25.8 months |
| Paclitaxel+ Bevacizumab | Overall Survival (OS) - ITT Population | 28.8 months |
Comparison: Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).p-value: 0.587795% CI: [0.75, 1.18]Log Rank
Comparison: Unstratified analysis.p-value: 0.800495% CI: [0.78, 1.21]Log Rank
Secondary
Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population
Time frame: From randomization till death or clinical cut-off (up to 244 weeks)
Population: High Baseline Plasma VEGF-A ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population | 74.2 percentage of participants |
| Paclitaxel+ Bevacizumab | Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population | 71.1 percentage of participants |
Secondary
Percentage of Participants Who Died - ITT Population
Time frame: From randomization till death or clinical cut-off (up to 244 weeks)
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Percentage of Participants Who Died - ITT Population | 64.9 percentage of participants |
| Paclitaxel+ Bevacizumab | Percentage of Participants Who Died - ITT Population | 64.0 percentage of participants |
Secondary
Percentage of Participants Who Were Alive at 1 Year - ITT Population
Time frame: 1 year
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Percentage of Participants Who Were Alive at 1 Year - ITT Population | 80.94 percentage of participants |
| Paclitaxel+ Bevacizumab | Percentage of Participants Who Were Alive at 1 Year - ITT Population | 82.47 percentage of participants |
Secondary
Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population
Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.
Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Population: Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population | 32.8 percentage of participants |
| Paclitaxel+ Bevacizumab | Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population | 54.3 percentage of participants |
p-value: 0.001795% CI: [8.73, 34.32]Fisher
Secondary
Percentage of Participants With an Objective Response - ITT Population
Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).
Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Population: Number of participants analyzed=participants from ITT population with measurable disease at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Percentage of Participants With an Objective Response - ITT Population | 33.2 percentage of participants |
| Paclitaxel+ Bevacizumab | Percentage of Participants With an Objective Response - ITT Population | 54.0 percentage of participants |
p-value: <0.000195% CI: [11.45, 30.11]Fisher
Secondary
Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population
Time frame: 1 year
Population: High Baseline Plasma VEGF-A ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel+Placebo | Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population | 69.27 percentage of participants |
| Paclitaxel+ Bevacizumab | Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population | 80.96 percentage of participants |