Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: A randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE).
Identifieur interne : 000176 ( PubMed/Curation ); précédent : 000175; suivant : 000177Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: A randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE).
Auteurs : Sibylle Loibl [Allemagne] ; Lorena De La Pena [Espagne] ; Valentina Nekljudova [Allemagne] ; Dimitrios Zardavas [Belgique] ; Stefan Michiels [France] ; Carsten Denkert [Allemagne] ; Mahdi Rezai [Allemagne] ; Bego A Bermejo [Espagne] ; Michael Untch [Allemagne] ; Soo Chin Lee [Singapour] ; Sabine Turri [France] ; Patrick Urban [Suisse] ; Sherko Kümmel [Allemagne] ; Guenther Steger [Autriche] ; Andrea Gombos [Belgique] ; Michael Lux [Allemagne] ; Martine J. Piccart [Belgique] ; Gunter Von Minckwitz [Allemagne] ; José Baselga [États-Unis] ; Sherene Loi [Australie]Source :
- European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Aminopyridines (administration et posologie), Aminopyridines (effets indésirables), Antigène KI-67 (métabolisme), Arrêt précoce d'essais cliniques, Australie, Biopsie, Europe, Facteurs temps, Femelle, Humains, Inhibiteurs de protéines kinases (administration et posologie), Inhibiteurs de protéines kinases (effets indésirables), Lymphocytes TIL (), Lésions hépatiques dues aux substances (étiologie), Marqueurs biologiques tumoraux (antagonistes et inhibiteurs), Marqueurs biologiques tumoraux (génétique), Marqueurs biologiques tumoraux (métabolisme), Morpholines (administration et posologie), Morpholines (effets indésirables), Mutation, Méthode en double aveugle, Paclitaxel (administration et posologie), Paclitaxel (effets indésirables), Phosphatidylinositol 3-kinases de classe I (antagonistes et inhibiteurs), Phosphatidylinositol 3-kinases de classe I (génétique), Phosphatidylinositol 3-kinases de classe I (métabolisme), Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Récepteur ErbB-2 (antagonistes et inhibiteurs), Récepteur ErbB-2 (métabolisme), Résultat thérapeutique, Sujet âgé, Traitement médicamenteux adjuvant, Traitement néoadjuvant (effets indésirables), Trastuzumab (administration et posologie), Trastuzumab (effets indésirables), Tumeurs du sein (anatomopathologie), Tumeurs du sein (enzymologie), Tumeurs du sein (traitement médicamenteux).
- MESH :
- administration et posologie : Aminopyridines, Inhibiteurs de protéines kinases, Morpholines, Paclitaxel, Trastuzumab.
- anatomopathologie : Tumeurs du sein.
- antagonistes et inhibiteurs : Marqueurs biologiques tumoraux, Phosphatidylinositol 3-kinases de classe I, Récepteur ErbB-2.
- effets indésirables : Aminopyridines, Inhibiteurs de protéines kinases, Morpholines, Paclitaxel, Protocoles de polychimiothérapie antinéoplasique, Traitement néoadjuvant, Trastuzumab.
- enzymologie : Tumeurs du sein.
- génétique : Marqueurs biologiques tumoraux, Phosphatidylinositol 3-kinases de classe I.
- métabolisme : Antigène KI-67, Marqueurs biologiques tumoraux, Phosphatidylinositol 3-kinases de classe I, Récepteur ErbB-2.
- traitement médicamenteux : Tumeurs du sein.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- étiologie : Lésions hépatiques dues aux substances.
- Adulte, Adulte d'âge moyen, Arrêt précoce d'essais cliniques, Australie, Biopsie, Europe, Facteurs temps, Femelle, Humains, Lymphocytes TIL, Mutation, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Traitement médicamenteux adjuvant.
English descriptors
- KwdEn :
- Adult, Aged, Aminopyridines (administration & dosage), Aminopyridines (adverse effects), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Australia, Biomarkers, Tumor (antagonists & inhibitors), Biomarkers, Tumor (genetics), Biomarkers, Tumor (metabolism), Biopsy, Breast Neoplasms (drug therapy), Breast Neoplasms (enzymology), Breast Neoplasms (pathology), Chemical and Drug Induced Liver Injury (etiology), Chemotherapy, Adjuvant, Class I Phosphatidylinositol 3-Kinases (antagonists & inhibitors), Class I Phosphatidylinositol 3-Kinases (genetics), Class I Phosphatidylinositol 3-Kinases (metabolism), Double-Blind Method, Early Termination of Clinical Trials, Europe, Female, Humans, Ki-67 Antigen (metabolism), Lymphocytes, Tumor-Infiltrating (drug effects), Middle Aged, Morpholines (administration & dosage), Morpholines (adverse effects), Mutation, Neoadjuvant Therapy (adverse effects), Paclitaxel (administration & dosage), Paclitaxel (adverse effects), Protein Kinase Inhibitors (administration & dosage), Protein Kinase Inhibitors (adverse effects), Receptor, ErbB-2 (antagonists & inhibitors), Receptor, ErbB-2 (metabolism), Time Factors, Trastuzumab (administration & dosage), Trastuzumab (adverse effects), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Aminopyridines, Morpholines, Paclitaxel, Protein Kinase Inhibitors, Trastuzumab.
- chemical , adverse effects : Aminopyridines, Morpholines, Paclitaxel, Protein Kinase Inhibitors, Trastuzumab.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols, Neoadjuvant Therapy.
- chemical , antagonists & inhibitors : Biomarkers, Tumor, Class I Phosphatidylinositol 3-Kinases, Receptor, ErbB-2.
- drug effects : Lymphocytes, Tumor-Infiltrating.
- drug therapy : Breast Neoplasms.
- enzymology : Breast Neoplasms.
- etiology : Chemical and Drug Induced Liver Injury.
- chemical , genetics : Biomarkers, Tumor, Class I Phosphatidylinositol 3-Kinases.
- chemical , metabolism : Biomarkers, Tumor, Class I Phosphatidylinositol 3-Kinases, Ki-67 Antigen, Receptor, ErbB-2.
- pathology : Breast Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Australia, Biopsy, Chemotherapy, Adjuvant, Double-Blind Method, Early Termination of Clinical Trials, Europe, Female, Humans, Middle Aged, Mutation, Time Factors, Treatment Outcome.
Abstract
The Neoadjuvant PI3K inhibition in HER2 OverExpressing Breast cancEr (NeoPHOEBE) trial evaluated the efficacy and safety of buparlisib, a pan-phosphatidylinositol 3-kinase (PI3K) inhibitor, plus trastuzumab and paclitaxel as neoadjuvant treatment for human epidermal growth factor receptor-2 positive (HER2+) breast cancer.
DOI: 10.1016/j.ejca.2017.08.020
PubMed: 28923573
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pubmed:28923573Le document en format XML
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<author><name sortKey="Loibl, Sibylle" sort="Loibl, Sibylle" uniqKey="Loibl S" first="Sibylle" last="Loibl">Sibylle Loibl</name>
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<author><name sortKey="Bermejo, Bego A" sort="Bermejo, Bego A" uniqKey="Bermejo B" first="Bego A" last="Bermejo">Bego A Bermejo</name>
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<author><name sortKey="Lee, Soo Chin" sort="Lee, Soo Chin" uniqKey="Lee S" first="Soo Chin" last="Lee">Soo Chin Lee</name>
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<author><name sortKey="Gombos, Andrea" sort="Gombos, Andrea" uniqKey="Gombos A" first="Andrea" last="Gombos">Andrea Gombos</name>
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<author><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
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<author><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: A randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE).</title>
<author><name sortKey="Loibl, Sibylle" sort="Loibl, Sibylle" uniqKey="Loibl S" first="Sibylle" last="Loibl">Sibylle Loibl</name>
<affiliation wicri:level="1"><nlm:affiliation>German Breast Group, Neu-Isenburg, Germany; Sana-Klinikum Offenbach, Germany. Electronic address: Sibylle.Loibl@gbg.de.</nlm:affiliation>
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<wicri:regionArea>German Breast Group, Neu-Isenburg, Germany; Sana-Klinikum Offenbach</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="De La Pena, Lorena" sort="De La Pena, Lorena" uniqKey="De La Pena L" first="Lorena" last="De La Pena">Lorena De La Pena</name>
<affiliation wicri:level="1"><nlm:affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>SOLTI Breast Cancer Research Group, Barcelona</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Nekljudova, Valentina" sort="Nekljudova, Valentina" uniqKey="Nekljudova V" first="Valentina" last="Nekljudova">Valentina Nekljudova</name>
<affiliation wicri:level="1"><nlm:affiliation>German Breast Group, Neu-Isenburg, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>German Breast Group, Neu-Isenburg</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Zardavas, Dimitrios" sort="Zardavas, Dimitrios" uniqKey="Zardavas D" first="Dimitrios" last="Zardavas">Dimitrios Zardavas</name>
<affiliation wicri:level="1"><nlm:affiliation>Breast International Group, Brussels, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Breast International Group, Brussels</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Michiels, Stefan" sort="Michiels, Stefan" uniqKey="Michiels S" first="Stefan" last="Michiels">Stefan Michiels</name>
<affiliation wicri:level="1"><nlm:affiliation>Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, France; CESP, Inserm U1018, Univ. Paris Sud, Univ. Paris-Saclay, Villejuif, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, France; CESP, Inserm U1018, Univ. Paris Sud, Univ. Paris-Saclay, Villejuif</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Denkert, Carsten" sort="Denkert, Carsten" uniqKey="Denkert C" first="Carsten" last="Denkert">Carsten Denkert</name>
<affiliation wicri:level="1"><nlm:affiliation>Institute of Pathology, Charité University Hospital, Berlin, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Institute of Pathology, Charité University Hospital, Berlin</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Rezai, Mahdi" sort="Rezai, Mahdi" uniqKey="Rezai M" first="Mahdi" last="Rezai">Mahdi Rezai</name>
<affiliation wicri:level="1"><nlm:affiliation>Luisenkrankenhaus Düsseldorf, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Luisenkrankenhaus Düsseldorf</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bermejo, Bego A" sort="Bermejo, Bego A" uniqKey="Bermejo B" first="Bego A" last="Bermejo">Bego A Bermejo</name>
<affiliation wicri:level="1"><nlm:affiliation>Hospital Clinico Universitario de Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Clinico Universitario de Valencia</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Untch, Michael" sort="Untch, Michael" uniqKey="Untch M" first="Michael" last="Untch">Michael Untch</name>
<affiliation wicri:level="1"><nlm:affiliation>Helios Klinikum Berlin-Buch, Department of Obstetrics and Gynaecology, Berlin, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Helios Klinikum Berlin-Buch, Department of Obstetrics and Gynaecology, Berlin</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Lee, Soo Chin" sort="Lee, Soo Chin" uniqKey="Lee S" first="Soo Chin" last="Lee">Soo Chin Lee</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Haematology-Oncology, National University Cancer Institute, Singapore.</nlm:affiliation>
<country xml:lang="fr">Singapour</country>
<wicri:regionArea>Department of Haematology-Oncology, National University Cancer Institute</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Turri, Sabine" sort="Turri, Sabine" uniqKey="Turri S" first="Sabine" last="Turri">Sabine Turri</name>
<affiliation wicri:level="1"><nlm:affiliation>Novartis Pharma SAS, Rueil Malmaison, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Novartis Pharma SAS, Rueil Malmaison</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Urban, Patrick" sort="Urban, Patrick" uniqKey="Urban P" first="Patrick" last="Urban">Patrick Urban</name>
<affiliation wicri:level="1"><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kummel, Sherko" sort="Kummel, Sherko" uniqKey="Kummel S" first="Sherko" last="Kümmel">Sherko Kümmel</name>
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<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Kliniken Essen-Mitte, Essen</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Steger, Guenther" sort="Steger, Guenther" uniqKey="Steger G" first="Guenther" last="Steger">Guenther Steger</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Austria; Comprehensive Cancer Center Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Austria; Comprehensive Cancer Center Vienna</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Gombos, Andrea" sort="Gombos, Andrea" uniqKey="Gombos A" first="Andrea" last="Gombos">Andrea Gombos</name>
<affiliation wicri:level="1"><nlm:affiliation>Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Lux, Michael" sort="Lux, Michael" uniqKey="Lux M" first="Michael" last="Lux">Michael Lux</name>
<affiliation wicri:level="1"><nlm:affiliation>University Breast Centre of Franconia, OBGYN Department, University Hospital Erlangen, CCC Erlangen-EMN, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University Breast Centre of Franconia, OBGYN Department, University Hospital Erlangen, CCC Erlangen-EMN</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Piccart, Martine J" sort="Piccart, Martine J" uniqKey="Piccart M" first="Martine J" last="Piccart">Martine J. Piccart</name>
<affiliation wicri:level="1"><nlm:affiliation>Breast International Group, Brussels, Belgium; Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Breast International Group, Brussels, Belgium; Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
<affiliation wicri:level="1"><nlm:affiliation>German Breast Group, Neu-Isenburg, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>German Breast Group, Neu-Isenburg</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
<affiliation wicri:level="1"><nlm:affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain; Memorial Sloan-Kettering Cancer Center, New York, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>SOLTI Breast Cancer Research Group, Barcelona, Spain; Memorial Sloan-Kettering Cancer Center, New York</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Loi, Sherene" sort="Loi, Sherene" uniqKey="Loi S" first="Sherene" last="Loi">Sherene Loi</name>
<affiliation wicri:level="1"><nlm:affiliation>Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Australian New Zealand Breast Cancer Trials Group (ANZBCTG), Newcastle, Australia. Electronic address: sherene.loi@petermac.org.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Australian New Zealand Breast Cancer Trials Group (ANZBCTG), Newcastle</wicri:regionArea>
</affiliation>
</author>
</analytic>
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<idno type="eISSN">1879-0852</idno>
<imprint><date when="2017" type="published">2017</date>
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<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Australia</term>
<term>Biomarkers, Tumor (antagonists & inhibitors)</term>
<term>Biomarkers, Tumor (genetics)</term>
<term>Biomarkers, Tumor (metabolism)</term>
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<term>Class I Phosphatidylinositol 3-Kinases (genetics)</term>
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<term>Double-Blind Method</term>
<term>Early Termination of Clinical Trials</term>
<term>Europe</term>
<term>Female</term>
<term>Humans</term>
<term>Ki-67 Antigen (metabolism)</term>
<term>Lymphocytes, Tumor-Infiltrating (drug effects)</term>
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<term>Paclitaxel (adverse effects)</term>
<term>Protein Kinase Inhibitors (administration & dosage)</term>
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<term>Biopsie</term>
<term>Europe</term>
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<term>Femelle</term>
<term>Humains</term>
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<term>Marqueurs biologiques tumoraux (métabolisme)</term>
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<term>Paclitaxel</term>
<term>Trastuzumab</term>
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<term>Class I Phosphatidylinositol 3-Kinases</term>
<term>Receptor, ErbB-2</term>
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<term>Arrêt précoce d'essais cliniques</term>
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<front><div type="abstract" xml:lang="en">The Neoadjuvant PI3K inhibition in HER2 OverExpressing Breast cancEr (NeoPHOEBE) trial evaluated the efficacy and safety of buparlisib, a pan-phosphatidylinositol 3-kinase (PI3K) inhibitor, plus trastuzumab and paclitaxel as neoadjuvant treatment for human epidermal growth factor receptor-2 positive (HER2+) breast cancer.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28923573</PMID>
<DateCreated><Year>2017</Year>
<Month>09</Month>
<Day>19</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>10</Month>
<Day>23</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>10</Month>
<Day>23</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-0852</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>85</Volume>
<PubDate><Year>2017</Year>
<Month>Nov</Month>
</PubDate>
</JournalIssue>
<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: A randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE).</ArticleTitle>
<Pagination><MedlinePgn>133-145</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0959-8049(17)31244-3</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2017.08.020</ELocationID>
<Abstract><AbstractText Label="AIM" NlmCategory="OBJECTIVE">The Neoadjuvant PI3K inhibition in HER2 OverExpressing Breast cancEr (NeoPHOEBE) trial evaluated the efficacy and safety of buparlisib, a pan-phosphatidylinositol 3-kinase (PI3K) inhibitor, plus trastuzumab and paclitaxel as neoadjuvant treatment for human epidermal growth factor receptor-2 positive (HER2+) breast cancer.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">NeoPHOEBE was a neoadjuvant, phase II, randomised, double-blind study. Women with HER2+ breast cancer were randomised within two independent cohorts by PIK3CA mutation status and, in each cohort stratified by oestrogen receptor (ER) status to receive buparlisib or placebo plus trastuzumab (first 6 weeks) followed by buparlisib or placebo with trastuzumab and paclitaxel. Primary end-point was pathological complete response (pCR) rate; key secondary end-point was objective response rate (ORR) at 6 weeks. Exploratory end-points were evaluation of Ki67 levels and change in tumour infiltrating lymphocytes (TILs) in intermediate biopsies at day 15.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Recruitment was suspended mainly due to liver toxicity after enrolment of 50 of the planned 256 patients. In each arm (buparlisib n = 25; placebo n = 25) 21 patients (84%) had wild type PIK3CA and 4 patients (16%) had mutant PIK3CA. Overall, pCR rate was similar between buparlisib and placebo arms (32.0% versus 40%; one-sided P = 0.811). A trend towards higher ORR (68.8% versus 33.3%; P = 0.053) and a significant decrease in Ki67 (75% versus 26.7%; P = 0.021) was observed in buparlisib versus placebo arm in the ER+ subgroup (Pinteraction = 0.03).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Addition of the pan-PI3K inhibitor buparlisib to taxane-trastuzumab-based therapy in HER2+ early breast cancer was not feasible. However, the higher ORR and Ki67 reduction in the ER+, HER2+ subgroup indicates a potential role for PI3K-targeted therapy in this setting and may warrant further investigation with better-tolerated second-generation PI3K inhibitors.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION IDENTIFIER" NlmCategory="UNASSIGNED">NCT01816594.</AbstractText>
<CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Loibl</LastName>
<ForeName>Sibylle</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>German Breast Group, Neu-Isenburg, Germany; Sana-Klinikum Offenbach, Germany. Electronic address: Sibylle.Loibl@gbg.de.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>de la Pena</LastName>
<ForeName>Lorena</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Nekljudova</LastName>
<ForeName>Valentina</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>German Breast Group, Neu-Isenburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Zardavas</LastName>
<ForeName>Dimitrios</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Breast International Group, Brussels, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Michiels</LastName>
<ForeName>Stefan</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, France; CESP, Inserm U1018, Univ. Paris Sud, Univ. Paris-Saclay, Villejuif, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Denkert</LastName>
<ForeName>Carsten</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Institute of Pathology, Charité University Hospital, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rezai</LastName>
<ForeName>Mahdi</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Luisenkrankenhaus Düsseldorf, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bermejo</LastName>
<ForeName>Begoña</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Hospital Clinico Universitario de Valencia, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Untch</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Helios Klinikum Berlin-Buch, Department of Obstetrics and Gynaecology, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lee</LastName>
<ForeName>Soo Chin</ForeName>
<Initials>SC</Initials>
<AffiliationInfo><Affiliation>Department of Haematology-Oncology, National University Cancer Institute, Singapore.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Turri</LastName>
<ForeName>Sabine</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Novartis Pharma SAS, Rueil Malmaison, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Urban</LastName>
<ForeName>Patrick</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Novartis Pharma AG, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kümmel</LastName>
<ForeName>Sherko</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Kliniken Essen-Mitte, Essen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Steger</LastName>
<ForeName>Guenther</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Austria; Comprehensive Cancer Center Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gombos</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lux</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>University Breast Centre of Franconia, OBGYN Department, University Hospital Erlangen, CCC Erlangen-EMN, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Piccart</LastName>
<ForeName>Martine J</ForeName>
<Initials>MJ</Initials>
<AffiliationInfo><Affiliation>Breast International Group, Brussels, Belgium; Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Von Minckwitz</LastName>
<ForeName>Gunter</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>German Breast Group, Neu-Isenburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Baselga</LastName>
<ForeName>José</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain; Memorial Sloan-Kettering Cancer Center, New York, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Loi</LastName>
<ForeName>Sherene</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Australian New Zealand Breast Cancer Trials Group (ANZBCTG), Newcastle, Australia. Electronic address: sherene.loi@petermac.org.</Affiliation>
</AffiliationInfo>
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<Language>eng</Language>
<GrantList CompleteYN="Y"><Grant><GrantID>P30 CA008748</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
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<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
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<Month>09</Month>
<Day>17</Day>
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<MedlineTA>Eur J Cancer</MedlineTA>
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<Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber>
<NameOfSubstance UI="C508053">ERBB2 protein, human</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber>
<NameOfSubstance UI="D018719">Receptor, ErbB-2</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>P188ANX8CK</RegistryNumber>
<NameOfSubstance UI="D000068878">Trastuzumab</NameOfSubstance>
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<PMID Version="1">24663045</PMID>
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