| 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. | Efficacy population. Here number of participants analyzed were those who were available for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00073.1(65.1 to 79.9)
- OG00180.6(69.6 to 88.3)
|
|
| |
| 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. | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Bevacizumab: TN Breast Cancer |
|
| 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. | | Posted | | Number | | percentage of participants | | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | | Posted | | Median | 95% Confidence Interval | months | | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | | Posted | | Median | 95% Confidence Interval | months | | From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | | Posted | | Number | | percentage of participants | | From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | | Posted | | Median | 95% Confidence Interval | months | | From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | Efficacy population. Here number of participants analyzed were those who were available for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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). | Efficacy population. Here number of participants analyzed were those who were available for this outcome measure. | Posted | | Median | Full Range | months | | From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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). | | Posted | | Mean | Standard Deviation | years | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 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. |
|
| 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). | Efficacy population. Here number of participants analyzed were those who were available for the evaluation of menopausal status. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| 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). | Efficacy population. Here number of participants analyzed were those who were available for the evaluation of ECOG PS. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. |
|
| 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). | Efficacy population. Here number of participants analyzed were those who were available for the evaluation of body weight. | Posted | | Mean | Standard Deviation | kilograms | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| 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). | Efficacy population. Here number of participants analyzed were those who were available for the evaluation of height. | Posted | | Mean | Standard Deviation | centimeters | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| 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). | Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BMI which was measured in kg/m^2. | Posted | | Mean | Standard Deviation | kg/m^2 | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| 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). | Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BRCA mutation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| Secondary | Duration of Bevacizumab as First Line Treatment | | | Posted | | Median | Full Range | months | | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| Secondary | Percentage of Participants With Temporary Discontinuation | | Efficacy population. Here number of participants were those who were temporary discontinued. | Posted | | Number | | percentage of participants | | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| Secondary | Percentage of Participants With Reasons for Temporary Discontinuation | | Efficacy population. Here number of participants were those who were temporary discontinued. | Posted | | Number | | percentage of participants | | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| Secondary | Percentage of Participants With Definitive Discontinuation | | Efficacy population. Here number of participants were those who were temporary discontinued. | Posted | | Number | | percentage of participants | | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
|
| Secondary | Percentage of Participants With Reasons for Definitive Discontinuation | | Efficacy population. Here number of participants were those who were definitive discontinued. | Posted | | Number | | percentage of participants | | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
|---|
| OG000 | Bevacizumab: HR+ Breast Cancer | Participants with HR+ 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. | | OG001 | 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 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. |
| |
| 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). | Efficacy population. Here number of participants analyzed were those who were available for the evaluation of metastatic sites. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | Bevacizumab: TN Breast Cancer | |
|
| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | Bevacizumab: TN Breast Cancer |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | Bevacizumab: TN Breast Cancer | |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| 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). | Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation. | Posted | | Number | | percentage of participants | | At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. |
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| Secondary | Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease | | Efficacy population. Here number of participants were those who were available for this evaluation. | Posted | | Number | | percentage of participants | | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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| Secondary | Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab | | | Posted | | Number | | percentage of participants | | From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment) | | | | ID | Title | Description |
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| OG000 | 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 of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, 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. | | OG001 | 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 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. |
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