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

January 25, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ACI
      • Buenos Aires, Argentina, C1426ANZ
      • Buenos Aires, Argentina, B1708EIL
      • Buenos Aires, Argentina, C1113AAC
      • Buenos Aires, Argentina, C1116ABC
      • Buenos Aires, Argentina, C1414CEF
      • Buenos aires, Argentina, C1417DTB
      • Capital Federal, Argentina, C1426ALV
      • La Pampa, Argentina, 6300
      • Mar Del Plata, Argentina, 7600
      • Rosario, Argentina, S2000DSK
      • San Miguel de Tucuman, Argentina, T4000IAK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Breast cancer patients with first line treatment with Avastin

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to a maximum of 36.4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to a maximum of 36.4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

October 4, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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