An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01215123
First received: September 27, 2010
Last updated: January 25, 2016
Last verified: January 2016

September 27, 2010
January 25, 2016
January 2010
July 2012   (final data collection date for primary outcome measure)
Time to Disease Progression (TDP) [ Time Frame: Up to a maximum of 36.4 months ] [ Designated as safety issue: No ]
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.
To assess the median time of treatment duration of Avastin [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01215123 on ClinicalTrials.gov Archive Site
Treatment Duration: Number of Bevacizumab Cycles [ Time Frame: Up to a maximum of 36.4 months ] [ Designated as safety issue: No ]
Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.
Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
Avastin in First Line Metastatic or Recurrent Breast Cancer. Retrospective Phase IV Study
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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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample
Breast cancer patients with first line treatment with Avastin
Breast Cancer
Drug: 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.
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.
Intervention: Drug: Bevacizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with metastatic breast cancer in first line treatment who have completed treatment with Avastin

Exclusion Criteria:

  • Patients not willing or unable to signed written consent form
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01215123
ML25100
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP