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This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve [AUC]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Participants | Experimental | Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 15 mg/kg iv every 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. | From the date of registration until the disease progression or death (up to 1541 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an Overall Response | The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmedabad | 380009 | India | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Carboplatin | Drug | to an AUC = 2, on days 1 and 8 of each 3-week cycle |
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| Gemcitabine | Drug | 1000 mg/m2 iv on days 1 and 8 of each 3-week cycle |
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| From the date of registration until the disease progression or death (up to 1541 days) |
| Percentage of Participants Achieving a Clinical Benefit Response (CBR) | Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From the date of registration until the disease progression or death (up to 1541 days) |
| Time to Progression (TTP) | Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression. | From the date of registration until the disease progression (up to 1541 days). |
| Overall Survival (OS) | Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method. | From the date of registration until the disease progression or death (up to 1541 days) |
| Number of Participants With an Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to 28 days after termination of study treatment (approximately 1569 days) |
| Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) | The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms. | Baseline, cycle 6 |
| Change From Baseline in Systolic Blood Pressure (SBP) | Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD). | Baseline, Cycle 6, 12 of treatment |
| Change From Baseline in Diastolic Blood Pressure (DBP) | Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD). | Baseline, Cycle 6, 12 of treatment |
| Bangalore |
| 560029 |
| India |
| Bangalore | 560054 | India |
| Delhi | 110029 | India |
| Gandhinagar | 382428 | India |
| Mumbai | 400012 | India |
| Mumbai | 400016 | India |
| Mumbai | 400020 | India |
| New Delhi | 110011 | India |
| New Delhi | 110085 | India |
| Pune | 411004 | India |
| Vellore | 632004 | India |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. | Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment | Posted | Median | 95% Confidence Interval | days | From the date of registration until the disease progression or death (up to 1541 days). |
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| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving an Overall Response | The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. | Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of registration until the disease progression or death (up to 1541 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Clinical Benefit Response (CBR) | Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of registration until the disease progression or death (up to 1541 days) |
| |||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression. | Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. | Posted | Median | 95% Confidence Interval | days | From the date of registration until the disease progression (up to 1541 days). |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method. | Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. | Posted | Median | 95% Confidence Interval | days | From the date of registration until the disease progression or death (up to 1541 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With an Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety population included all participants who received at least one dose of study treatment. | Posted | Number | participants | Up to 28 days after termination of study treatment (approximately 1569 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) | The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms. | Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. Here, n signifies the number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, cycle 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) | Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD). | Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | millimetre of mercury (mmHg) | Baseline, Cycle 6, 12 of treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) | Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD). | Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mmHg | Baseline, Cycle 6, 12 of treatment |
|
|
Up to 28 days after termination of study treatment (approximately 1569 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Particiapants | Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle. | 17 | 40 | 18 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Disease Progression | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Septic Shock | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Streptococcal Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Viral Respiratory Tract Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Oxygen Saturation Decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
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| Transient Ischemic Attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Disease Progression | General disorders | MedDRA 15.1 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Units | Counts |
|---|---|
| Participants |
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