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AVAREG Study: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

NCT ID: NCT01777932

Last Updated: 2016-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

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Budapest, , Hungary

Site Status

Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Eger, , Hungary

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Győr, , Hungary

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Gyula, , Hungary

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Kaposvár, , Hungary

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Kecskemét, , Hungary

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Kistarcsa, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Salgótarján, , Hungary

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Szeged, , Hungary

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Szekszárd, , Hungary

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Szentes, , Hungary

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Székesfehérvár, , Hungary

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Szolnok, , Hungary

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Szombathely, , Hungary

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Tatabánya, , Hungary

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Veszprém, , Hungary

Site Status

Zalaegerszeg, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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ML21647

Identifier Type: -

Identifier Source: org_study_id

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