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Completed

NCT Number: NCT01215123

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time to Disease Progression (TDP)

    Time frame: 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 outcomes

  1. Treatment Duration: Number of Bevacizumab Cycles

    Time frame: Up to a maximum of 36.4 months

    Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Avastin in First Line Metastatic or Recurrent Breast Cancer. Retrospective Phase IV Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 6, 2010
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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