Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: January 25, 2016
Last verified: January 2016
  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 Intervention
Breast Cancer
Drug: Bevacizumab

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to Disease Progression (TDP) [ Time Frame: Up to a maximum of 36.4 months ] [ Designated as safety issue: No ]
    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:
  • Treatment Duration: Number of Bevacizumab Cycles [ Time Frame: Up to a maximum of 36.4 months ] [ Designated as safety issue: No ]
    Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.


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)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Argentina
Buenos Aires, Argentina, B1708EIL
Buenos Aires, Argentina, C1113AAC
Buenos Aires, Argentina, C1116ABC
Buenos Aires, Argentina, C1199ACI
Buenos Aires, Argentina, C1414CEF
Buenos aires, Argentina, C1417DTB
Buenos Aires, Argentina, C1426ANZ
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01215123     History of Changes
Other Study ID Numbers: ML25100 
Study First Received: September 27, 2010
Results First Received: January 25, 2016
Last Updated: January 25, 2016
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
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 29, 2016