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This observational study will assess the median time of treatment duration and the safety of Avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. Data will be collected for approximately 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression (TDP) | Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Up to a maximum of 36.4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Duration: Number of Bevacizumab Cycles | Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles. | Up to a maximum of 36.4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients with first line treatment with Avastin
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | B1708EIL | Argentina | ||||
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The study duration is January 2010 (first data collected) to July 2012 (last data collected). In this study, medical records of participants evaluated between 2008 and 2012 were reviewed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Disease Progression (TDP) | Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | All enrolled participants | Posted | Median | Full Range | months | Up to a maximum of 36.4 months |
|
Baseline up to 36.4 months
All enrolled participants
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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 | Bevacizumab | Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Buenos Aires |
| C1113AAC |
| Argentina |
| Buenos Aires | C1116ABC | Argentina |
| Buenos Aires | C1199ACI | Argentina |
| Buenos Aires | C1414CEF | Argentina |
| Buenos Aires | C1417DTB | Argentina |
| Buenos Aires | C1426ANZ | Argentina |
| Capital Federal | C1426ALV | Argentina |
| La Pampa | 6300 | Argentina |
| Mar del Plata | 7600 | Argentina |
| Rosario | S2000DSK | Argentina |
| San Miguel de Tucumán | T4000IAK | Argentina |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Treatment Duration: Number of Bevacizumab Cycles | Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles. | All enrolled participants | Posted | Median | Full Range | cycles | Up to a maximum of 36.4 months |
|
|
|
| 10 |
| 28 |
| 23 |
| 28 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edemas | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cardiac event (not specified) | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomits | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Liver event (not specified) | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutropenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgias | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthralgias | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Allergy | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |