A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.
NCT ID: NCT00717405
Last Updated: 2016-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2008-10-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Standard chemotherapy
As prescribed
bevacizumab [Avastin]
15mg/kg iv 3 weekly in cycles 1-8
trastuzumab [Herceptin]
8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.
Interventions
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Standard chemotherapy
As prescribed
bevacizumab [Avastin]
15mg/kg iv 3 weekly in cycles 1-8
trastuzumab [Herceptin]
8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.
Eligibility Criteria
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Inclusion Criteria
* inflammatory breast cancer;
* HER2-positive tumors;
* performance status 0-2.
Exclusion Criteria
* previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
* clinically significant cardiovascular disease, or history of thrombotic disorders.
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Besançon, , France
Bordeaux, , France
Brest, , France
Caen, , France
Clermont-Ferrand, , France
Dijon, , France
La Tronche, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Paris, , France
Reims, , France
Rennes, , France
Rouen, , France
Saint-Brieuc, , France
Saint-Cloud, , France
Saint-Herblain, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Strasbourg, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Countries
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References
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Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.
Other Identifiers
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2008-000783-16
Identifier Type: -
Identifier Source: secondary_id
ML21531
Identifier Type: -
Identifier Source: org_study_id
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