AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer
A Multicenter, Single-arm, Observational Study Describing the Clinical Benefits of Bevacizumab (Avastin) Treatment in Patients With Metastatic Breast Cancer (AVAREG Study)
1 other identifier
observational
220
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2007
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 24, 2013
CompletedFirst Posted
Study publicly available on registry
January 29, 2013
CompletedResults Posted
Study results publicly available
February 5, 2016
CompletedFebruary 5, 2016
January 1, 2016
4.3 years
January 24, 2013
January 7, 2016
January 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.
Approximately 5 years
Secondary Outcomes (10)
One Year Survival
Approximately 5 years
Time to Discontinuation (TTD) of Bevacizumab Treatment
Approximately 5 years
Participants With Hormone Receptor Status at Diagnosis
Baseline (Day 1)
Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry
Approximately 5 years
Participants With Tumor Stage at Diagnosis
Baseline (Day 1)
- +5 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Patients with metastatic breast cancer initiated on treatment with Avastin in combination with paclitaxel
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Unknown Facility
Budapest, 1031, Hungary
Unknown Facility
Budapest, 1076, Hungary
Unknown Facility
Budapest, 1082, Hungary
Unknown Facility
Budapest, 1088, Hungary
Unknown Facility
Budapest, 1097, Hungary
Unknown Facility
Budapest, 1106, Hungary
Unknown Facility
Budapest, 1115, Hungary
Unknown Facility
Budapest, 1122, Hungary
Unknown Facility
Budapest, 1125, Hungary
Unknown Facility
Budapest, 1135, Hungary
Unknown Facility
Budapest, 1145, Hungary
Unknown Facility
Debrecen, 4012, Hungary
Unknown Facility
Debrecen, H-4031, Hungary
Unknown Facility
Eger, 3300, Hungary
Unknown Facility
Győr, 9023, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Kaposvár, 7400, Hungary
Unknown Facility
Kecskemét, 6000, Hungary
Unknown Facility
Kistarcsa, 2143, Hungary
Unknown Facility
Miskolc, 3526, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Pécs, 7624, Hungary
Unknown Facility
Salgótarján, 3100, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Szekszárd, 7100, Hungary
Unknown Facility
Szentes, 6600, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Szolnok, 5004, Hungary
Unknown Facility
Szombathely, 9700, Hungary
Unknown Facility
Tatabánya, 2800, Hungary
Unknown Facility
Veszprém, 8200, Hungary
Unknown Facility
Zalaegerszeg, 8900, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2013
First Posted
January 29, 2013
Study Start
December 1, 2007
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
February 5, 2016
Results First Posted
February 5, 2016
Record last verified: 2016-01