Breast Cancer
Conditions
Brief summary
This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. Data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=18 years of age * HER2-metastatic breast cancer or locally advanced breast cancer * Patients with Avastin as first line therapy administered for at least 12 months * Patients without disease progression after the beginning of Avastin treatment for at least 12 months
Exclusion criteria
* Patients not willing to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Percentage of participants that reported metastatic disease in less than or equal to (\<=) 3 sites or greater than (\>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With HR Status at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with \< or \>=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis | From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline) | Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported. |
| Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis | From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline) | Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported. |
| Disease-Free Interval | From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline) | Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Mean Age at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50 percentage \[%\] of waking hours \[h\]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Mean Body Weight at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
| Mean Height at the Time of Local or Metastatic Progression | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Progression or Death | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline) | Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. |
| Progression-Free Survival | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline) | Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase. |
| Time to Progression | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline) | Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase. |
| Percentage of Participants With Death | From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment) | Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date. |
| Overall Survival (OS) | From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment) | OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date. |
| Duration of Bevacizumab as First Line Treatment | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | — |
| Percentage of Participants With Temporary Discontinuation | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | — |
| Percentage of Participants With Reasons for Temporary Discontinuation | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | — |
| Percentage of Participants With Definitive Discontinuation | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | — |
| Percentage of Participants With Reasons for Definitive Discontinuation | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | — |
| Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | — |
| Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | — |
| Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline) | Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase. |
Countries
France
Participant flow
Pre-assignment details
In total, 228 participants were included but 1 participant did not fulfill the inclusion criteria, therefore not included in the analysis. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab: HR+ Breast Cancer Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for \>=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months. | 135 |
| Bevacizumab: TN Breast Cancer Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for \>=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months. | 67 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 58 | 35 |
| Overall Study | Lost to Follow-up | 12 | 5 |
Baseline characteristics
| Characteristic | Bevacizumab: HR+ Breast Cancer | Bevacizumab: TN Breast Cancer | Total |
|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 12 | 55.6 years STANDARD_DEVIATION 10.3 | 55.2 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 135 Participants | 67 Participants | 202 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 150 | 9 / 77 |
| serious Total, serious adverse events | 10 / 150 | 4 / 77 |
Outcome results
Primary
Disease-Free Interval
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Disease-Free Interval | 51.0 months |
| Bevacizumab: TN Breast Cancer | Disease-Free Interval | 28.0 months |
Primary
Mean Age at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Mean Age at the Time of Local or Metastatic Progression | 54.5 years | Standard Deviation 11.8 |
| Bevacizumab: TN Breast Cancer | Mean Age at the Time of Local or Metastatic Progression | 55.5 years | Standard Deviation 10.4 |
Primary
Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression
BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BMI which was measured in kg/m\^2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression | 25.6 kg/m^2 | Standard Deviation 4.9 |
| Bevacizumab: TN Breast Cancer | Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression | 24.7 kg/m^2 | Standard Deviation 4.2 |
Primary
Mean Body Weight at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the evaluation of body weight.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Mean Body Weight at the Time of Local or Metastatic Progression | 66.8 kilograms | Standard Deviation 13.3 |
| Bevacizumab: TN Breast Cancer | Mean Body Weight at the Time of Local or Metastatic Progression | 66.2 kilograms | Standard Deviation 11.1 |
Primary
Mean Height at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the evaluation of height.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Mean Height at the Time of Local or Metastatic Progression | 161.7 centimeters | Standard Deviation 5.9 |
| Bevacizumab: TN Breast Cancer | Mean Height at the Time of Local or Metastatic Progression | 164.1 centimeters | Standard Deviation 5.6 |
Primary
Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression
Percentage of participants that reported metastatic disease in less than or equal to (\<=) 3 sites or greater than (\>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the evaluation of metastatic sites.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression | <=3 | 56.7 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression | >3 | 43.3 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression | <=3 | 71.2 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression | >3 | 28.8 percentage of participants |
Primary
Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression | 24.2 percentage of participants |
Primary
Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.
Time frame: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis | 73.1 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis | 80.6 percentage of participants |
Primary
Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis
Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.
Time frame: From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis | 68.7 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis | 56.7 percentage of participants |
Primary
Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BRCA mutation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression | 1.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression | 4.6 percentage of participants |
Primary
Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER+/PR+ | 64.0 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER+/PR- | 31.4 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER-/PR+ | 3.5 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER-/PR- | 1.2 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER-/PR- | 100 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER+/PR+ | 0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER-/PR+ | 0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression | ER+/PR- | 0 percentage of participants |
Primary
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression
ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50 percentage \[%\] of waking hours \[h\]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the evaluation of ECOG PS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 0 | 46.7 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 1 | 43.4 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 2 | 9.0 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 3 | 0.8 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 3 | 0.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 0 | 54.7 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 2 | 7.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression | 1 | 37.7 percentage of participants |
Primary
Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression | ER+ | 92.2 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression | ER- | 4.4 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression | Unknown | 3.3 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression | ER+ | 0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression | ER- | 93.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression | Unknown | 7.0 percentage of participants |
Primary
Percentage of Participants With HR Status at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With HR Status at the Time of Local or Metastatic Progression | HR+ | 98.9 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With HR Status at the Time of Local or Metastatic Progression | HR- | 1.1 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With HR Status at the Time of Local or Metastatic Progression | HR+ | 0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With HR Status at the Time of Local or Metastatic Progression | HR- | 100 percentage of participants |
Primary
Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression
The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with \< or \>=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression | <10% | 3.8 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression | >=10% | 11.3 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression | Unknown | 85.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression | <10% | 5.3 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression | >=10% | 13.2 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression | Unknown | 81.6 percentage of participants |
Primary
Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression
Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the evaluation of menopausal status.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression | Premenopausal | 31.6 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression | Menopausal | 68.4 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression | Premenopausal | 18.6 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression | Menopausal | 81.4 percentage of participants |
Primary
Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression
Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Lung | 34.1 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Lymph nodes | 11.9 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Central nervous system | 2.2 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Skin | 5.2 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Liver | 35.6 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Pleura | 6.7 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Soft tissue | 10.4 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Other | 8.1 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Bone | 63.7 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Other | 7.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Bone | 46.3 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Lung | 29.9 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Liver | 17.9 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Central nervous system | 4.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Soft tissue | 14.9 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Lymph nodes | 28.4 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Skin | 4.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression | Pleura | 7.5 percentage of participants |
Primary
Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression
MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | Low | 22.8 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | Intermediate | 5.1 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | High | 3.8 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | Unknown | 68.4 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | Unknown | 70.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | Low | 7.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | High | 17.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression | Intermediate | 5.0 percentage of participants |
Primary
Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression | 100 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression | 100 percentage of participants |
Primary
Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression | 41.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression | 59.7 percentage of participants |
Primary
Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression | PR+ | 64.4 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression | PR- | 31.1 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression | Unknown | 4.4 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression | PR+ | 0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression | PR- | 93.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression | Unknown | 7.0 percentage of participants |
Primary
Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression
Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).
Time frame: At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)
Population: Efficacy population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression | 64.4 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression | 43.3 percentage of participants |
Secondary
Duration of Bevacizumab as First Line Treatment
Time frame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Duration of Bevacizumab as First Line Treatment | 21.2 months |
| Bevacizumab: TN Breast Cancer | Duration of Bevacizumab as First Line Treatment | 18.6 months |
Secondary
Overall Survival (OS)
OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.
Time frame: From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Overall Survival (OS) | 57.2 months |
| Bevacizumab: TN Breast Cancer | Overall Survival (OS) | 49.4 months |
Secondary
Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease
Time frame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population. Here number of participants were those who were available for this evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease | 25.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease | 17.0 percentage of participants |
Secondary
Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab
Time frame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab | 99.3 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab | 98.5 percentage of participants |
Secondary
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Time frame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Population: Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) | CR | 28.2 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) | PR | 58.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) | CR | 33.9 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) | PR | 45.8 percentage of participants |
Secondary
Percentage of Participants With Death
Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.
Time frame: From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Death | 37.8 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Death | 41.8 percentage of participants |
Secondary
Percentage of Participants With Definitive Discontinuation
Time frame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population. Here number of participants were those who were temporary discontinued.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Definitive Discontinuation | 75.6 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Definitive Discontinuation | 88.1 percentage of participants |
Secondary
Percentage of Participants With Disease Progression or Death
Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment.
Time frame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)
Population: Efficacy population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Disease Progression or Death | 79.3 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Disease Progression or Death | 80.6 percentage of participants |
Secondary
Percentage of Participants With Reasons for Definitive Discontinuation
Time frame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population. Here number of participants were those who were definitive discontinued.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Progressive disease | 54.9 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Adverse event | 24.5 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Participant's or Investigator's decision | 16.7 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Unspecified | 3.9 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Unspecified | 1.7 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Progressive disease | 58.6 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Participant's or Investigator's decision | 15.5 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Definitive Discontinuation | Adverse event | 24.1 percentage of participants |
Secondary
Percentage of Participants With Reasons for Temporary Discontinuation
Time frame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population. Here number of participants were those who were temporary discontinued.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Adverse Event | 34.2 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Surgery | 34.2 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Participant's or Investigator's Decision | 15.8 percentage of participants |
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Unspecified | 21.1 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Unspecified | 10.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Adverse Event | 35.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Participant's or Investigator's Decision | 20.0 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Reasons for Temporary Discontinuation | Surgery | 45.0 percentage of participants |
Secondary
Percentage of Participants With Temporary Discontinuation
Time frame: From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)
Population: Efficacy population. Here number of participants were those who were temporary discontinued.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Percentage of Participants With Temporary Discontinuation | 28.1 percentage of participants |
| Bevacizumab: TN Breast Cancer | Percentage of Participants With Temporary Discontinuation | 29.9 percentage of participants |
Secondary
Progression-Free Survival
Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Time frame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Population: Efficacy population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Progression-Free Survival | 25.3 months |
| Bevacizumab: TN Breast Cancer | Progression-Free Survival | 21.2 months |
Secondary
Time to Progression
Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.
Time frame: From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)
Population: Efficacy population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab: HR+ Breast Cancer | Time to Progression | 25.3 months |
| Bevacizumab: TN Breast Cancer | Time to Progression | 21.2 months |