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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: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Avastin in First Line Metastatic or Recurrent Breast Cancer. Retrospective Phase IV Study

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • To assess the median time of treatment duration of Avastin [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety profile of Avastin [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast cancer patients with first line treatment with Avastin

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215123

Locations
Argentina
Buenos Aires, Argentina, 1417
Buenos Aires, Argentina, C1116ABC
Buenos Aires, Argentina, C1414CEF
Buenos Aires, Argentina, C1426ANZ
Buenos Aires, Argentina, C1199ACI
Buenos Aires, Argentina, 1113
Buenos Aires, Argentina, B1708EIL
Capital Federal, Argentina, C1426ALV
La Pampa, Argentina, 6300
Mar Del Plata, Argentina, 7600
Rosario, Argentina, S2000DSK
San Miguel de Tucuman, Argentina, T4000IAK
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01215123     History of Changes
Other Study ID Numbers: ML25100
Study First Received: September 27, 2010
Last Updated: November 1, 2012
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013