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A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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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

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