Breast Cancer
Conditions
Brief summary
The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab. The secondary objectives of this trial are to: * compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab * evaluate the safety and tolerability of bevacizumab An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.
Interventions
DRUGBevacizumab
Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * operable primary invasive breast cancer; * completed definitive loco-regional surgery; * primary tumor centrally confirmed as triple negative.
Exclusion criteria
* locally advanced breast cancers; * previous breast cancer history; * clinically significant cardiovascular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Invasive Disease-free Survival (IDFS) Event | Event driven (until data cutoff: 29 February 2012: up to 49 months) | IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. |
| Percentage of Participants With Invasive Disease-free Survival (IDFS) Events | Event driven (until data cutoff: 29 February 2012 up to 49 months) | IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented. |
| Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer | Event driven (until data cutoff: 29 February 2012: up to 49 months) | IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. |
| Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer | Event driven (until data cutoff: 29 February 2012: up to 49 months) | IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease-Free Survival (DFS) Event | Event driven (until data cutoff: 29 February 2012: up to 49 months) | DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). |
| Percentage of Participants With Disease-Free Survival (DFS) Events | Event driven (until data cutoff: 29 February 2012: up to 49 months) | DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented. |
| Time to Overall Survival (OS) Event | Event driven (until data cutoff: 29 February 2012: up to 49 months) | OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive. |
| Percentage of Participants With Distant Disease-Free Survival (DDFS) Events | Event driven (until data cutoff: 29 February 2012: up to 49 months) | DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented. |
| Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Through end of study: 30 June 2014: up to 77 months | An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
| Time to Distant Disease-Free Survival (DDFS) Event | Event driven (until data cutoff: 29 February 2012: up to 49 months) | DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). |
| Percentage of Participants With Overall Survival (OS) Event | Event driven (until data cut off: 29 February 2012: up to 49 months) | OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive. |
| Time to Breast Cancer-Free Interval (BCFI) Event | Event driven (until data cutoff: 29 February 2012: up to 49 months) | BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause. |
| Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events | Event driven (until data cutoff: 29 February 2012: up to 49 months) | BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented. |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Costa Rica, Czechia, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab and Chemotherapy Participants randomized to receive bevacizumab and chemotherapy | 1,301 |
| Chemotherapy Participants randomized to receive chemotherapy alone | 1,290 |
| Total | 2,591 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative/Other | 22 | 75 |
| Overall Study | Adverse Event/Intermittent Illness | 255 | 29 |
| Overall Study | Breast Cancer Recurrence/2nd Primary | 30 | 60 |
| Overall Study | Death | 4 | 5 |
| Overall Study | Failure to Return | 1 | 4 |
| Overall Study | Other Protocol Violation | 5 | 21 |
| Overall Study | Refused Treatment/Did Not Cooperate | 52 | 42 |
| Overall Study | Violation Criteria at Entry | 3 | 17 |
| Overall Study | Withdrew Consent | 59 | 55 |
Baseline characteristics
| Characteristic | Bevacizumab and Chemotherapy | Chemotherapy | Total |
|---|---|---|---|
| Age, Customized >= 40 to < 65 years | 952 participants | 916 participants | 1868 participants |
| Age, Customized < 40 years | 231 participants | 253 participants | 484 participants |
| Age, Customized >= 65 years | 118 participants | 121 participants | 239 participants |
| Sex: Female, Male Female | 1301 Participants | 1290 Participants | 2591 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1,268 / 1,288 | 1,233 / 1,271 | 0 / 1,288 | 0 / 1,271 |
| serious Total, serious adverse events | 379 / 1,288 | 250 / 1,271 | 45 / 1,288 | 48 / 1,271 |
Outcome results
Primary
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.
Time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events | Percentage of Participants with Events | 14.5 Percentage of participants |
| Bevacizumab and Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events | Percentage of Participants without Events | 85.5 Percentage of participants |
| Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events | Percentage of Participants with Events | 15.9 Percentage of participants |
| Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events | Percentage of Participants without Events | 84.1 Percentage of participants |
Primary
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer | Percentage of Participants with Events | 13.5 Percentage of participants |
| Bevacizumab and Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer | Percentage of Participants without Events | 86.5 Percentage of participants |
| Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer | Percentage of Participants with Events | 14.7 Percentage of participants |
| Chemotherapy | Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer | Percentage of Participants without Events | 85.3 Percentage of participants |
Primary
Time to Invasive Disease-free Survival (IDFS) Event
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab and Chemotherapy | Time to Invasive Disease-free Survival (IDFS) Event | NA Months |
| Chemotherapy | Time to Invasive Disease-free Survival (IDFS) Event | NA Months |
p-value: 0.18195% CI: [0.72, 1.07]Log Rank
Primary
Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab and Chemotherapy | Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer | NA Months |
| Chemotherapy | Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer | NA Months |
p-value: 0.196695% CI: [0.71, 1.07]Log Rank
Secondary
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: Through end of study: 30 June 2014: up to 77 months
Population: Safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all other patients were analyzed in the chemotherapy arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Deaths | 31 Participants |
| Bevacizumab and Chemotherapy | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Serious Adverse Events | 379 Participants |
| Bevacizumab and Chemotherapy | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Adverse Events (5% Reporting Threshold) | 1268 Participants |
| Chemotherapy | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Adverse Events (5% Reporting Threshold) | 1233 Participants |
| Chemotherapy | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Serious Adverse Events | 250 Participants |
| Chemotherapy | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Deaths | 41 Participants |
| Bevacizumab and Chemotherapy (>18 Months) | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Adverse Events (5% Reporting Threshold) | 0 Participants |
| Bevacizumab and Chemotherapy (>18 Months) | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Serious Adverse Events | 45 Participants |
| Bevacizumab and Chemotherapy (>18 Months) | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Deaths | 113 Participants |
| Chemotherapy (>18 Months) | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Serious Adverse Events | 48 Participants |
| Chemotherapy (>18 Months) | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Deaths | 106 Participants |
| Chemotherapy (>18 Months) | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths | Adverse Events (5% Reporting Threshold) | 0 Participants |
Secondary
Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events
BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events | Percentage of Participants with Events | 13.2 Percentage of participants |
| Bevacizumab and Chemotherapy | Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events | Percentage of Participants without Events | 86.8 Percentage of participants |
| Chemotherapy | Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events | Percentage of Participants without Events | 85.8 Percentage of participants |
| Chemotherapy | Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events | Percentage of Participants with Events | 14.2 Percentage of participants |
Secondary
Percentage of Participants With Disease-Free Survival (DFS) Events
DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Percentage of Participants With Disease-Free Survival (DFS) Events | with Events | 14.7 Percentage of participants |
| Bevacizumab and Chemotherapy | Percentage of Participants With Disease-Free Survival (DFS) Events | without Events | 85.3 Percentage of participants |
| Chemotherapy | Percentage of Participants With Disease-Free Survival (DFS) Events | with Events | 16.1 Percentage of participants |
| Chemotherapy | Percentage of Participants With Disease-Free Survival (DFS) Events | without Events | 83.9 Percentage of participants |
Secondary
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events
DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Percentage of Participants With Distant Disease-Free Survival (DDFS) Events | Percentage of Participants without Events | 88.3 Percentage of participants |
| Bevacizumab and Chemotherapy | Percentage of Participants With Distant Disease-Free Survival (DDFS) Events | Percentage of Participants with Events | 11.7 Percentage of participants |
| Chemotherapy | Percentage of Participants With Distant Disease-Free Survival (DDFS) Events | Percentage of Participants without Events | 87.3 Percentage of participants |
| Chemotherapy | Percentage of Participants With Distant Disease-Free Survival (DDFS) Events | Percentage of Participants with Events | 12.7 Percentage of participants |
Secondary
Percentage of Participants With Overall Survival (OS) Event
OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
Time frame: Event driven (until data cut off: 30 June 2014: up to 77 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | with events | 11.1 percentage of participants |
| Bevacizumab and Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | without events | 88.9 percentage of participants |
| Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | with events | 11.6 percentage of participants |
| Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | without events | 88.4 percentage of participants |
Secondary
Percentage of Participants With Overall Survival (OS) Event
OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
Time frame: Event driven (until data cut off: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab and Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | with events | 7.1 percentage of participants |
| Bevacizumab and Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | without events | 92.9 percentage of participants |
| Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | with events | 8.3 percentage of participants |
| Chemotherapy | Percentage of Participants With Overall Survival (OS) Event | without events | 91.7 percentage of participants |
p-value: 0.231895% CI: [0.64, 1.12]Log Rank
Secondary
Time to Breast Cancer-Free Interval (BCFI) Event
BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat participants, defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab and Chemotherapy | Time to Breast Cancer-Free Interval (BCFI) Event | NA Months |
| Chemotherapy | Time to Breast Cancer-Free Interval (BCFI) Event | NA Months |
p-value: 0.279295% CI: [0.72, 1.1]Log Rank
Secondary
Time to Disease-Free Survival (DFS) Event
DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab and Chemotherapy | Time to Disease-Free Survival (DFS) Event | NA Months |
| Chemotherapy | Time to Disease-Free Survival (DFS) Event | NA Months |
p-value: 0.183295% CI: [0.72, 1.07]Log Rank
Secondary
Time to Distant Disease-Free Survival (DDFS) Event
DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab and Chemotherapy | Time to Distant Disease-Free Survival (DDFS) Event | NA Months |
| Chemotherapy | Time to Distant Disease-Free Survival (DDFS) Event | NA Months |
p-value: 0.330995% CI: [0.72, 1.12]Log Rank
Secondary
Time to Overall Survival (OS) Event
OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
Time frame: Event driven (until data cutoff: 30 June 2014: up to 77 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab and Chemotherapy | Time to Overall Survival (OS) Event | NA Months |
| Chemotherapy | Time to Overall Survival (OS) Event | NA Months |
p-value: 0.524795% CI: [0.74, 1.17]Log Rank
Secondary
Time to Overall Survival (OS) Event
OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Population: Intent-to-treat population, defined as all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab and Chemotherapy | Time to Overall Survival (OS) Event | NA Months |
| Chemotherapy | Time to Overall Survival (OS) Event | NA Months |