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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215123
• Other study ID #: ML25100
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: January 25, 2016
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to a maximum of 36.4 months	No
Secondary	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	No