A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale.
Identifieur interne : 001271 ( Main/Exploration ); précédent : 001270; suivant : 001272A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale.
Auteurs : Steven J. Isakoff [États-Unis] ; Shannon Puhalla [États-Unis] ; Susan M. Domchek [États-Unis] ; Michael Friedlander [Australie] ; Bella Kaufman [Israël] ; Mark Robson [États-Unis] ; Melinda L. Telli [États-Unis] ; Véronique Diéras [France] ; Hyo Sook Han [États-Unis] ; Judy E. Garber [États-Unis] ; Eric F. Johnson [États-Unis] ; David Maag [États-Unis] ; Qin Qin [États-Unis] ; Vincent L. Giranda [États-Unis] ; Stacie P. Shepherd [États-Unis]Source :
- Future oncology (London, England) [ 1744-8301 ] ; 2017.
Descripteurs français
- KwdFr :
- Benzimidazoles (administration et posologie), Benzimidazoles (pharmacocinétique), Carboplatine (administration et posologie), Carboplatine (pharmacocinétique), Dacarbazine (administration et posologie), Dacarbazine (analogues et dérivés), Dacarbazine (pharmacocinétique), Femelle, Humains, Modèles statistiques, Paclitaxel (administration et posologie), Paclitaxel (pharmacocinétique), Plan de recherche, Protocoles cliniques, Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Protéine BRCA1 (génétique), Protéine BRCA2 (génétique), Surveillance pharmacologique, Taille d'échantillon, Tumeurs du sein (anatomopathologie), Tumeurs du sein (génétique), Tumeurs du sein (traitement médicamenteux).
- MESH :
- administration et posologie : Benzimidazoles, Carboplatine, Dacarbazine, Paclitaxel.
- analogues et dérivés : Dacarbazine.
- anatomopathologie : Tumeurs du sein.
- effets indésirables : Protocoles de polychimiothérapie antinéoplasique.
- génétique : Protéine BRCA1, Protéine BRCA2, Tumeurs du sein.
- pharmacocinétique : Benzimidazoles, Carboplatine, Dacarbazine, Paclitaxel.
- traitement médicamenteux : Tumeurs du sein.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Femelle, Humains, Modèles statistiques, Plan de recherche, Protocoles cliniques, Surveillance pharmacologique, Taille d'échantillon.
English descriptors
- KwdEn :
- Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), BRCA1 Protein (genetics), BRCA2 Protein (genetics), Benzimidazoles (administration & dosage), Benzimidazoles (pharmacokinetics), Breast Neoplasms (drug therapy), Breast Neoplasms (genetics), Breast Neoplasms (pathology), Carboplatin (administration & dosage), Carboplatin (pharmacokinetics), Clinical Protocols, Dacarbazine (administration & dosage), Dacarbazine (analogs & derivatives), Dacarbazine (pharmacokinetics), Drug Monitoring, Female, Humans, Models, Statistical, Paclitaxel (administration & dosage), Paclitaxel (pharmacokinetics), Research Design, Sample Size.
- MESH :
- chemical , administration & dosage : Benzimidazoles, Carboplatin, Dacarbazine, Paclitaxel.
- chemical , analogs & derivatives : Dacarbazine.
- chemical , genetics : BRCA1 Protein, BRCA2 Protein.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- drug therapy : Breast Neoplasms.
- genetics : Breast Neoplasms.
- pathology : Breast Neoplasms.
- chemical , pharmacokinetics : Benzimidazoles, Carboplatin, Dacarbazine, Paclitaxel.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Clinical Protocols, Drug Monitoring, Female, Humans, Models, Statistical, Research Design, Sample Size.
Abstract
Veliparib is an orally administered poly(ADP-ribose) polymerase inhibitor that is being studied in Phase I-III clinical trials, including Phase III studies in non-small-cell lung cancer, ovarian cancer and breast cancer. Tumor cells with deleterious BRCA1 or BRCA2 mutations are deficient in homologous recombination DNA repair and are intrinsically sensitive to platinum therapy and poly(ADP-ribose) polymerase inhibitors. We describe herein the design and rationale of a Phase II trial investigating whether the addition of veliparib to temozolomide or carboplatin/paclitaxel provides clinical benefit over carboplatin/paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer harboring a deleterious BRCA1 or BRCA2 germline mutation (Trial registration: EudraCT 2011-002913-12, NCT01506609).
DOI: 10.2217/fon-2016-0412
PubMed: 27739325
Affiliations:
- Australie, France, Israël, États-Unis
- Californie, Floride, Illinois, Massachusetts, Pennsylvanie, État de New York, Île-de-France
Links toward previous steps (curation, corpus...)
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Le document en format XML
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Isakoff</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Massachusetts General Hospital, Boston, MA 02114, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, Massachusetts General Hospital, Boston, MA 02114</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Puhalla, Shannon" sort="Puhalla, Shannon" uniqKey="Puhalla S" first="Shannon" last="Puhalla">Shannon Puhalla</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, University of Pittsburgh Cancer Institute, Pittsburgh, PA 15232, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Pittsburgh Cancer Institute, Pittsburgh, PA 15232</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Domchek, Susan M" sort="Domchek, Susan M" uniqKey="Domchek S" first="Susan M" last="Domchek">Susan M. Domchek</name><affiliation wicri:level="2"><nlm:affiliation>Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA 19104, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA 19104</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name><affiliation wicri:level="1"><nlm:affiliation>Gynaecological Cancer Centre, Royal Hospital for Women, Sydney, NSW 2031, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Gynaecological Cancer Centre, Royal Hospital for Women, Sydney, NSW 2031</wicri:regionArea><wicri:noRegion>NSW 2031</wicri:noRegion></affiliation></author><author><name sortKey="Kaufman, Bella" sort="Kaufman, Bella" uniqKey="Kaufman B" first="Bella" last="Kaufman">Bella Kaufman</name><affiliation wicri:level="1"><nlm:affiliation>Department of General Oncology, Chaim Sheba Medical Center, Ramat Gan 52 621, Israel.</nlm:affiliation><country xml:lang="fr">Israël</country><wicri:regionArea>Department of General Oncology, Chaim Sheba Medical Center, Ramat Gan 52 621</wicri:regionArea><wicri:noRegion>Ramat Gan 52 621</wicri:noRegion></affiliation></author><author><name sortKey="Robson, Mark" sort="Robson, Mark" uniqKey="Robson M" first="Mark" last="Robson">Mark Robson</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10022, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10022</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Telli, Melinda L" sort="Telli, Melinda L" uniqKey="Telli M" first="Melinda L" last="Telli">Melinda L. Telli</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medical Oncology, Stanford University School of Medicine, Stanford, CA 94305, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medical Oncology, Stanford University School of Medicine, Stanford, CA 94305</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Dieras, Veronique" sort="Dieras, Veronique" uniqKey="Dieras V" first="Véronique" last="Diéras">Véronique Diéras</name><affiliation wicri:level="3"><nlm:affiliation>Department of Medical Oncology, Institut Curie, Paris 75248, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Medical Oncology, Institut Curie, Paris 75248</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Han, Hyo Sook" sort="Han, Hyo Sook" uniqKey="Han H" first="Hyo Sook" last="Han">Hyo Sook Han</name><affiliation wicri:level="2"><nlm:affiliation>The Center for Women's Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Center for Women's Oncology, Moffitt Cancer Center, Tampa, FL 33612</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Garber, Judy E" sort="Garber, Judy E" uniqKey="Garber J" first="Judy E" last="Garber">Judy E. Garber</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Johnson, Eric F" sort="Johnson, Eric F" uniqKey="Johnson E" first="Eric F" last="Johnson">Eric F. Johnson</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., Chicago, IL 60064, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc., Chicago, IL 60064</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Maag, David" sort="Maag, David" uniqKey="Maag D" first="David" last="Maag">David Maag</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., Chicago, IL 60064, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc., Chicago, IL 60064</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Qin, Qin" sort="Qin, Qin" uniqKey="Qin Q" first="Qin" last="Qin">Qin Qin</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., Chicago, IL 60064, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc., Chicago, IL 60064</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Giranda, Vincent L" sort="Giranda, Vincent L" uniqKey="Giranda V" first="Vincent L" last="Giranda">Vincent L. Giranda</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., Chicago, IL 60064, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc., Chicago, IL 60064</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Shepherd, Stacie P" sort="Shepherd, Stacie P" uniqKey="Shepherd S" first="Stacie P" last="Shepherd">Stacie P. Shepherd</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., Chicago, IL 60064, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AbbVie Inc., Chicago, IL 60064</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author></analytic><series><title level="j">Future oncology (London, England)</title><idno type="eISSN">1744-8301</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>BRCA1 Protein (genetics)</term><term>BRCA2 Protein (genetics)</term><term>Benzimidazoles (administration & dosage)</term><term>Benzimidazoles (pharmacokinetics)</term><term>Breast Neoplasms (drug therapy)</term><term>Breast Neoplasms (genetics)</term><term>Breast Neoplasms (pathology)</term><term>Carboplatin (administration & dosage)</term><term>Carboplatin (pharmacokinetics)</term><term>Clinical Protocols</term><term>Dacarbazine (administration & dosage)</term><term>Dacarbazine (analogs & derivatives)</term><term>Dacarbazine (pharmacokinetics)</term><term>Drug Monitoring</term><term>Female</term><term>Humans</term><term>Models, Statistical</term><term>Paclitaxel (administration & dosage)</term><term>Paclitaxel (pharmacokinetics)</term><term>Research Design</term><term>Sample Size</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Benzimidazoles (administration et posologie)</term><term>Benzimidazoles (pharmacocinétique)</term><term>Carboplatine (administration et posologie)</term><term>Carboplatine (pharmacocinétique)</term><term>Dacarbazine (administration et posologie)</term><term>Dacarbazine (analogues et dérivés)</term><term>Dacarbazine (pharmacocinétique)</term><term>Femelle</term><term>Humains</term><term>Modèles statistiques</term><term>Paclitaxel (administration et posologie)</term><term>Paclitaxel (pharmacocinétique)</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Protéine BRCA1 (génétique)</term><term>Protéine BRCA2 (génétique)</term><term>Surveillance pharmacologique</term><term>Taille d'échantillon</term><term>Tumeurs du sein (anatomopathologie)</term><term>Tumeurs du sein (génétique)</term><term>Tumeurs du sein (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Benzimidazoles</term><term>Carboplatin</term><term>Dacarbazine</term><term>Paclitaxel</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Dacarbazine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>BRCA1 Protein</term><term>BRCA2 Protein</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Benzimidazoles</term><term>Carboplatine</term><term>Dacarbazine</term><term>Paclitaxel</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Dacarbazine</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Protéine BRCA1</term><term>Protéine BRCA2</term><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="pharmacocinétique" xml:lang="fr"><term>Benzimidazoles</term><term>Carboplatine</term><term>Dacarbazine</term><term>Paclitaxel</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Benzimidazoles</term><term>Carboplatin</term><term>Dacarbazine</term><term>Paclitaxel</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Protocols</term><term>Drug Monitoring</term><term>Female</term><term>Humans</term><term>Models, Statistical</term><term>Research Design</term><term>Sample Size</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Femelle</term><term>Humains</term><term>Modèles statistiques</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Surveillance pharmacologique</term><term>Taille d'échantillon</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Veliparib is an orally administered poly(ADP-ribose) polymerase inhibitor that is being studied in Phase I-III clinical trials, including Phase III studies in non-small-cell lung cancer, ovarian cancer and breast cancer. Tumor cells with deleterious BRCA1 or BRCA2 mutations are deficient in homologous recombination DNA repair and are intrinsically sensitive to platinum therapy and poly(ADP-ribose) polymerase inhibitors. We describe herein the design and rationale of a Phase II trial investigating whether the addition of veliparib to temozolomide or carboplatin/paclitaxel provides clinical benefit over carboplatin/paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer harboring a deleterious BRCA1 or BRCA2 germline mutation (Trial registration: EudraCT 2011-002913-12, NCT01506609).</div></front></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>Israël</li><li>États-Unis</li></country><region><li>Californie</li><li>Floride</li><li>Illinois</li><li>Massachusetts</li><li>Pennsylvanie</li><li>État de New York</li><li>Île-de-France</li></region></list><tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Isakoff, Steven J" sort="Isakoff, Steven J" uniqKey="Isakoff S" first="Steven J" last="Isakoff">Steven J. Isakoff</name></region><name sortKey="Domchek, Susan M" sort="Domchek, Susan M" uniqKey="Domchek S" first="Susan M" last="Domchek">Susan M. Domchek</name><name sortKey="Garber, Judy E" sort="Garber, Judy E" uniqKey="Garber J" first="Judy E" last="Garber">Judy E. Garber</name><name sortKey="Giranda, Vincent L" sort="Giranda, Vincent L" uniqKey="Giranda V" first="Vincent L" last="Giranda">Vincent L. Giranda</name><name sortKey="Han, Hyo Sook" sort="Han, Hyo Sook" uniqKey="Han H" first="Hyo Sook" last="Han">Hyo Sook Han</name><name sortKey="Johnson, Eric F" sort="Johnson, Eric F" uniqKey="Johnson E" first="Eric F" last="Johnson">Eric F. Johnson</name><name sortKey="Maag, David" sort="Maag, David" uniqKey="Maag D" first="David" last="Maag">David Maag</name><name sortKey="Puhalla, Shannon" sort="Puhalla, Shannon" uniqKey="Puhalla S" first="Shannon" last="Puhalla">Shannon Puhalla</name><name sortKey="Qin, Qin" sort="Qin, Qin" uniqKey="Qin Q" first="Qin" last="Qin">Qin Qin</name><name sortKey="Robson, Mark" sort="Robson, Mark" uniqKey="Robson M" first="Mark" last="Robson">Mark Robson</name><name sortKey="Shepherd, Stacie P" sort="Shepherd, Stacie P" uniqKey="Shepherd S" first="Stacie P" last="Shepherd">Stacie P. Shepherd</name><name sortKey="Telli, Melinda L" sort="Telli, Melinda L" uniqKey="Telli M" first="Melinda L" last="Telli">Melinda L. Telli</name></country><country name="Australie"><noRegion><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name></noRegion></country><country name="Israël"><noRegion><name sortKey="Kaufman, Bella" sort="Kaufman, Bella" uniqKey="Kaufman B" first="Bella" last="Kaufman">Bella Kaufman</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Dieras, Veronique" sort="Dieras, Veronique" uniqKey="Dieras V" first="Véronique" last="Diéras">Véronique Diéras</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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