Trial Information
A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)
Inclusion Criteria:
- Patients with metastatic breast cancer initiated on first-line treatment with Avastin
in combination with paclitaxel according to the current Hungarian summary of Product
Characteristics
- Patients with metastatic breast cancer initiated within 6 months before the start of
the study on treatment with Avastin according to the current Hungarian Summary of
Product Characteristics
Exclusion Criteria:
Contraindications for Avastin according to the current Hungarian Summary of Product
Characteristics:
- Hypersensitivity to active ingredient of Avastin or to any excipients
- Hypersensitivity to products produced in Chinese hamster cells or to other
recombinant or humanized antibodies
- Pregnancy
- Untreated central nervous system metastases
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Progression-free survival: Time to tumor progression or death (whichever occurs first) from the start of Avastin treatment, as determined by the usual follow-up examinations of routine clinical practice
Outcome Time Frame:
approximately 5 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Hungary: National Institute of Pharmacy
Study ID:
ML21647
NCT ID:
NCT01777932
Start Date:
December 2007
Completion Date:
January 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms