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AVEREL: A Randomized Phase III Trial Evaluating Bevacizumab in Combination With Docetaxel and Trastuzumab As First-Line Therapy for HER2-Positive Locally Recurrent/Metastatic Breast Cancer

Identifieur interne : 005123 ( Main/Exploration ); précédent : 005122; suivant : 005124

AVEREL: A Randomized Phase III Trial Evaluating Bevacizumab in Combination With Docetaxel and Trastuzumab As First-Line Therapy for HER2-Positive Locally Recurrent/Metastatic Breast Cancer

Auteurs : Luca Gianni ; Gilles H. Romieu [France] ; Michail Lichinitser [Russie] ; Sergio V. Serrano [Brésil] ; Mauro Mansutti [Italie] ; Xavier Pivot [France] ; Paola Mariani [Italie] ; Fabrice Andre [France] ; Arlene Chan [Australie] ; Oleg Lipatov [Royaume-Uni] ; Stephen Chan [Royaume-Uni] ; Andrew Wardley [Royaume-Uni] ; Richard Greil [Autriche] ; Nicola Moore [Suisse] ; Sylvie Prot [Suisse] ; Celine Pallaud [Suisse] ; Vladimir Semiglazov [Russie]

Source :

RBID : Pascal:13-0188852

Descripteurs français

English descriptors

Abstract

Purpose The AVEREL trial [A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2-Positive Metastatic Breast Cancer] evaluated first-line bevacizumab-containing therapy for human epidermal growth factor receptor 2 (HER2) -positive locally recurrent/metastatic breast cancer (LR/MBC). Patients and Methods Patients with measurable/evaluable HER2-positive LR/MBC who had not received trastuzumab or chemotherapy for LR/MBC were stratified by prior adjuvant trastuzumab, prior (neo)adjuvant taxane, hormone receptor status, and measurable disease and were randomly assigned to receive docetaxel 100 mg/m2 plus trastuzumab 8 mg/kg loading dose followed by 6 mg/kg either with bevacizumab 15 mg/kg or without bevacizumab, all administered every 3 weeks. The primary end point was progression-free survival (PFS). Additional end points included overall survival, response rate (RR), safety, quality of life, and translational research.


Affiliations:


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Le document en format XML

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</inist:fA14>
<country>Russie</country>
<wicri:noRegion>N.N. Petrov Research Institute of Oncology</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint>
<date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Advanced stage</term>
<term>Antiangiogenic agent</term>
<term>Antineoplastic agent</term>
<term>Bevacizumab</term>
<term>Breast cancer</term>
<term>C-Onc gene</term>
<term>Cancerology</term>
<term>Chemotherapy</term>
<term>Clinical trial</term>
<term>Docetaxel</term>
<term>Drug combination</term>
<term>First line treatment</term>
<term>Human Epidermal growth factor Receptor 2</term>
<term>Immunomodulator</term>
<term>Mammary gland</term>
<term>Metastasis</term>
<term>Monoclonal antibody</term>
<term>Phase III trial</term>
<term>Protooncogene</term>
<term>Randomization</term>
<term>Recurrent</term>
<term>Relapse</term>
<term>Trastuzumab</term>
<term>Vascular endothelium growth factor</term>
<term>erbB2 Gene</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Essai clinique phase III</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Bévacizumab</term>
<term>Association médicamenteuse</term>
<term>Trastuzumab</term>
<term>Chimiothérapie</term>
<term>Anticorps monoclonal</term>
<term>Gène onc cellulaire</term>
<term>Docétaxel</term>
<term>Protooncogène</term>
<term>Gène erbB2</term>
<term>Traitement de première intention</term>
<term>Récidive</term>
<term>Récidivant</term>
<term>Stade avancé</term>
<term>Métastase</term>
<term>Cancer du sein</term>
<term>Glande mammaire</term>
<term>Cancérologie</term>
<term>Facteur croissance endothélium vasculaire</term>
<term>Anticancéreux</term>
<term>Immunomodulateur</term>
<term>Antiangiogénique</term>
<term>Niveau local</term>
<term>Récepteur HER2</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Purpose The AVEREL trial [A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2-Positive Metastatic Breast Cancer] evaluated first-line bevacizumab-containing therapy for human epidermal growth factor receptor 2 (HER2) -positive locally recurrent/metastatic breast cancer (LR/MBC). Patients and Methods Patients with measurable/evaluable HER2-positive LR/MBC who had not received trastuzumab or chemotherapy for LR/MBC were stratified by prior adjuvant trastuzumab, prior (neo)adjuvant taxane, hormone receptor status, and measurable disease and were randomly assigned to receive docetaxel 100 mg/m
<sup>2</sup>
plus trastuzumab 8 mg/kg loading dose followed by 6 mg/kg either with bevacizumab 15 mg/kg or without bevacizumab, all administered every 3 weeks. The primary end point was progression-free survival (PFS). Additional end points included overall survival, response rate (RR), safety, quality of life, and translational research.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Autriche</li>
<li>Brésil</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Russie</li>
<li>Suisse</li>
</country>
<region>
<li>Angleterre</li>
<li>Bourgogne-Franche-Comté</li>
<li>District fédéral central</li>
<li>Franche-Comté</li>
<li>Grand Manchester</li>
<li>Languedoc-Roussillon</li>
<li>Lombardie</li>
<li>Occitanie (région administrative)</li>
</region>
<settlement>
<li>Besançon</li>
<li>Manchester</li>
<li>Milan</li>
<li>Montpellier</li>
<li>Moscou</li>
</settlement>
</list>
<tree>
<noCountry>
<name sortKey="Gianni, Luca" sort="Gianni, Luca" uniqKey="Gianni L" first="Luca" last="Gianni">Luca Gianni</name>
</noCountry>
<country name="France">
<region name="Occitanie (région administrative)">
<name sortKey="Romieu, Gilles H" sort="Romieu, Gilles H" uniqKey="Romieu G" first="Gilles H." last="Romieu">Gilles H. Romieu</name>
</region>
<name sortKey="Andre, Fabrice" sort="Andre, Fabrice" uniqKey="Andre F" first="Fabrice" last="Andre">Fabrice Andre</name>
<name sortKey="Pivot, Xavier" sort="Pivot, Xavier" uniqKey="Pivot X" first="Xavier" last="Pivot">Xavier Pivot</name>
</country>
<country name="Russie">
<region name="District fédéral central">
<name sortKey="Lichinitser, Michail" sort="Lichinitser, Michail" uniqKey="Lichinitser M" first="Michail" last="Lichinitser">Michail Lichinitser</name>
</region>
<name sortKey="Semiglazov, Vladimir" sort="Semiglazov, Vladimir" uniqKey="Semiglazov V" first="Vladimir" last="Semiglazov">Vladimir Semiglazov</name>
</country>
<country name="Brésil">
<noRegion>
<name sortKey="Serrano, Sergio V" sort="Serrano, Sergio V" uniqKey="Serrano S" first="Sergio V." last="Serrano">Sergio V. Serrano</name>
</noRegion>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Mansutti, Mauro" sort="Mansutti, Mauro" uniqKey="Mansutti M" first="Mauro" last="Mansutti">Mauro Mansutti</name>
</noRegion>
<name sortKey="Mariani, Paola" sort="Mariani, Paola" uniqKey="Mariani P" first="Paola" last="Mariani">Paola Mariani</name>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Chan, Arlene" sort="Chan, Arlene" uniqKey="Chan A" first="Arlene" last="Chan">Arlene Chan</name>
</noRegion>
</country>
<country name="Royaume-Uni">
<noRegion>
<name sortKey="Lipatov, Oleg" sort="Lipatov, Oleg" uniqKey="Lipatov O" first="Oleg" last="Lipatov">Oleg Lipatov</name>
</noRegion>
<name sortKey="Chan, Stephen" sort="Chan, Stephen" uniqKey="Chan S" first="Stephen" last="Chan">Stephen Chan</name>
<name sortKey="Wardley, Andrew" sort="Wardley, Andrew" uniqKey="Wardley A" first="Andrew" last="Wardley">Andrew Wardley</name>
</country>
<country name="Autriche">
<noRegion>
<name sortKey="Greil, Richard" sort="Greil, Richard" uniqKey="Greil R" first="Richard" last="Greil">Richard Greil</name>
</noRegion>
</country>
<country name="Suisse">
<noRegion>
<name sortKey="Moore, Nicola" sort="Moore, Nicola" uniqKey="Moore N" first="Nicola" last="Moore">Nicola Moore</name>
</noRegion>
<name sortKey="Pallaud, Celine" sort="Pallaud, Celine" uniqKey="Pallaud C" first="Celine" last="Pallaud">Celine Pallaud</name>
<name sortKey="Prot, Sylvie" sort="Prot, Sylvie" uniqKey="Prot S" first="Sylvie" last="Prot">Sylvie Prot</name>
</country>
</tree>
</affiliations>
</record>

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