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AVAREG Study: 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:
NCT01777932
First received: January 24, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

This multicenter, single-arm observational study will evaluate the clinical benefits of Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin treatment within 6 months prior to study start will also be eligible. Data will be collected from patients for up to 5 years.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG 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:
  • 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 [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1-year survival: Percentage of patients still alive one year after the start of Avastin treatment [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Time to discontinuation of Avastin treatment (date of last Avastin dose) in combination with paclitaxel due to any cause (tumor progression, toxicity or other causes) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival in patients with triple negative receptor status [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: December 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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

Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777932

Locations
Hungary
Budapest, Hungary, 1122
Budapest, Hungary, 1031
Budapest, Hungary, 1097
Budapest, Hungary, 1115
Budapest, Hungary, 1145
Budapest, Hungary, 1076
Budapest, Hungary, 1125
Budapest, Hungary, 1082
Budapest, Hungary, 1106
Budapest, Hungary, 1088
Budapest, Hungary, 1135
Debrecen, Hungary, 4012
Debrecen, Hungary, H-4031
Eger, Hungary, 3300
Gyor, Hungary, 9023
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Kecskemet, Hungary, 6000
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3526
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7624
Salgótarján, Hungary, 3100
Szeged, Hungary, 6720
Szekesfehervar, Hungary, 8000
Szekszard, Hungary, 7100
Szentes, Hungary, 6600
Szolnok, Hungary, 5004
Szombathely, Hungary, 9700
Tatabánya, Hungary, 2800
Veszprem, Hungary, 8200
Zalaegerszeg, Hungary, 8900
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: NCT01777932     History of Changes
Other Study ID Numbers: ML21647
Study First Received: January 24, 2013
Last Updated: January 25, 2013
Health Authority: Hungary: National Institute of Pharmacy

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013