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

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01215123
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-01
• Results First Submitted: 2016-01-25
• Results First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Results First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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Exclusion Criteria

• Patients not willing or unable to signed written consent form

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Time to Disease Progression (TDP)	Up to a maximum of 36.4 months	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Duration: Number of Bevacizumab Cycles	Up to a maximum of 36.4 months	Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.