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/Corpus ); 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 ; Lorena De La Pena ; Valentina Nekljudova ; Dimitrios Zardavas ; Stefan Michiels ; Carsten Denkert ; Mahdi Rezai ; Bego A Bermejo ; Michael Untch ; Soo Chin Lee ; Sabine Turri ; Patrick Urban ; Sherko Kümmel ; Guenther Steger ; Andrea Gombos ; Michael Lux ; Martine J. Piccart ; Gunter Von Minckwitz ; José Baselga ; Sherene LoiSource :
- European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2017.
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
Links to Exploration step
pubmed:28923573Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><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><nlm:affiliation>German Breast Group, Neu-Isenburg, Germany; Sana-Klinikum Offenbach, Germany. Electronic address: Sibylle.Loibl@gbg.de.</nlm:affiliation>
</affiliation>
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<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><nlm:affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain.</nlm:affiliation>
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<author><name sortKey="Nekljudova, Valentina" sort="Nekljudova, Valentina" uniqKey="Nekljudova V" first="Valentina" last="Nekljudova">Valentina Nekljudova</name>
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</affiliation>
</author>
<author><name sortKey="Zardavas, Dimitrios" sort="Zardavas, Dimitrios" uniqKey="Zardavas D" first="Dimitrios" last="Zardavas">Dimitrios Zardavas</name>
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<author><name sortKey="Michiels, Stefan" sort="Michiels, Stefan" uniqKey="Michiels S" first="Stefan" last="Michiels">Stefan Michiels</name>
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<author><name sortKey="Denkert, Carsten" sort="Denkert, Carsten" uniqKey="Denkert C" first="Carsten" last="Denkert">Carsten Denkert</name>
<affiliation><nlm:affiliation>Institute of Pathology, Charité University Hospital, Berlin, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Rezai, Mahdi" sort="Rezai, Mahdi" uniqKey="Rezai M" first="Mahdi" last="Rezai">Mahdi Rezai</name>
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</affiliation>
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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>
<affiliation><nlm:affiliation>Hospital Clinico Universitario de Valencia, Spain.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Untch, Michael" sort="Untch, Michael" uniqKey="Untch M" first="Michael" last="Untch">Michael Untch</name>
<affiliation><nlm:affiliation>Helios Klinikum Berlin-Buch, Department of Obstetrics and Gynaecology, Berlin, Germany.</nlm:affiliation>
</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><nlm:affiliation>Department of Haematology-Oncology, National University Cancer Institute, Singapore.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Turri, Sabine" sort="Turri, Sabine" uniqKey="Turri S" first="Sabine" last="Turri">Sabine Turri</name>
<affiliation><nlm:affiliation>Novartis Pharma SAS, Rueil Malmaison, France.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Urban, Patrick" sort="Urban, Patrick" uniqKey="Urban P" first="Patrick" last="Urban">Patrick Urban</name>
<affiliation><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Kummel, Sherko" sort="Kummel, Sherko" uniqKey="Kummel S" first="Sherko" last="Kümmel">Sherko Kümmel</name>
<affiliation><nlm:affiliation>Kliniken Essen-Mitte, Essen, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Steger, Guenther" sort="Steger, Guenther" uniqKey="Steger G" first="Guenther" last="Steger">Guenther Steger</name>
<affiliation><nlm:affiliation>Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Austria; Comprehensive Cancer Center Vienna, Austria.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Gombos, Andrea" sort="Gombos, Andrea" uniqKey="Gombos A" first="Andrea" last="Gombos">Andrea Gombos</name>
<affiliation><nlm:affiliation>Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Lux, Michael" sort="Lux, Michael" uniqKey="Lux M" first="Michael" last="Lux">Michael Lux</name>
<affiliation><nlm:affiliation>University Breast Centre of Franconia, OBGYN Department, University Hospital Erlangen, CCC Erlangen-EMN, Germany.</nlm:affiliation>
</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><nlm:affiliation>Breast International Group, Brussels, Belgium; Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</nlm:affiliation>
</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><nlm:affiliation>German Breast Group, Neu-Isenburg, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
<affiliation><nlm:affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain; Memorial Sloan-Kettering Cancer Center, New York, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Loi, Sherene" sort="Loi, Sherene" uniqKey="Loi S" first="Sherene" last="Loi">Sherene Loi</name>
<affiliation><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>
</affiliation>
</author>
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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>
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</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><nlm:affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Nekljudova, Valentina" sort="Nekljudova, Valentina" uniqKey="Nekljudova V" first="Valentina" last="Nekljudova">Valentina Nekljudova</name>
<affiliation><nlm:affiliation>German Breast Group, Neu-Isenburg, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Zardavas, Dimitrios" sort="Zardavas, Dimitrios" uniqKey="Zardavas D" first="Dimitrios" last="Zardavas">Dimitrios Zardavas</name>
<affiliation><nlm:affiliation>Breast International Group, Brussels, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Michiels, Stefan" sort="Michiels, Stefan" uniqKey="Michiels S" first="Stefan" last="Michiels">Stefan Michiels</name>
<affiliation><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>
</affiliation>
</author>
<author><name sortKey="Denkert, Carsten" sort="Denkert, Carsten" uniqKey="Denkert C" first="Carsten" last="Denkert">Carsten Denkert</name>
<affiliation><nlm:affiliation>Institute of Pathology, Charité University Hospital, Berlin, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Rezai, Mahdi" sort="Rezai, Mahdi" uniqKey="Rezai M" first="Mahdi" last="Rezai">Mahdi Rezai</name>
<affiliation><nlm:affiliation>Luisenkrankenhaus Düsseldorf, Germany.</nlm:affiliation>
</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><nlm:affiliation>Hospital Clinico Universitario de Valencia, Spain.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Untch, Michael" sort="Untch, Michael" uniqKey="Untch M" first="Michael" last="Untch">Michael Untch</name>
<affiliation><nlm:affiliation>Helios Klinikum Berlin-Buch, Department of Obstetrics and Gynaecology, Berlin, Germany.</nlm:affiliation>
</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><nlm:affiliation>Department of Haematology-Oncology, National University Cancer Institute, Singapore.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Turri, Sabine" sort="Turri, Sabine" uniqKey="Turri S" first="Sabine" last="Turri">Sabine Turri</name>
<affiliation><nlm:affiliation>Novartis Pharma SAS, Rueil Malmaison, France.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Urban, Patrick" sort="Urban, Patrick" uniqKey="Urban P" first="Patrick" last="Urban">Patrick Urban</name>
<affiliation><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Kummel, Sherko" sort="Kummel, Sherko" uniqKey="Kummel S" first="Sherko" last="Kümmel">Sherko Kümmel</name>
<affiliation><nlm:affiliation>Kliniken Essen-Mitte, Essen, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Steger, Guenther" sort="Steger, Guenther" uniqKey="Steger G" first="Guenther" last="Steger">Guenther Steger</name>
<affiliation><nlm:affiliation>Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Austria; Comprehensive Cancer Center Vienna, Austria.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Gombos, Andrea" sort="Gombos, Andrea" uniqKey="Gombos A" first="Andrea" last="Gombos">Andrea Gombos</name>
<affiliation><nlm:affiliation>Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Lux, Michael" sort="Lux, Michael" uniqKey="Lux M" first="Michael" last="Lux">Michael Lux</name>
<affiliation><nlm:affiliation>University Breast Centre of Franconia, OBGYN Department, University Hospital Erlangen, CCC Erlangen-EMN, Germany.</nlm:affiliation>
</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><nlm:affiliation>Breast International Group, Brussels, Belgium; Université Libre de Bruxelles, Institut Jules Rue Héger-Bordet 1, Medical Oncology Clinic, Belgium.</nlm:affiliation>
</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><nlm:affiliation>German Breast Group, Neu-Isenburg, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
<affiliation><nlm:affiliation>SOLTI Breast Cancer Research Group, Barcelona, Spain; Memorial Sloan-Kettering Cancer Center, New York, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Loi, Sherene" sort="Loi, Sherene" uniqKey="Loi S" first="Sherene" last="Loi">Sherene Loi</name>
<affiliation><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>
</affiliation>
</author>
</analytic>
<series><title level="j">European journal of cancer (Oxford, England : 1990)</title>
<idno type="eISSN">1879-0852</idno>
<imprint><date when="2017" type="published">2017</date>
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<term>Aged</term>
<term>Aminopyridines (administration & dosage)</term>
<term>Aminopyridines (adverse effects)</term>
<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>
<term>Biopsy</term>
<term>Breast Neoplasms (drug therapy)</term>
<term>Breast Neoplasms (enzymology)</term>
<term>Breast Neoplasms (pathology)</term>
<term>Chemical and Drug Induced Liver Injury (etiology)</term>
<term>Chemotherapy, Adjuvant</term>
<term>Class I Phosphatidylinositol 3-Kinases (antagonists & inhibitors)</term>
<term>Class I Phosphatidylinositol 3-Kinases (genetics)</term>
<term>Class I Phosphatidylinositol 3-Kinases (metabolism)</term>
<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>
<term>Middle Aged</term>
<term>Morpholines (administration & dosage)</term>
<term>Morpholines (adverse effects)</term>
<term>Mutation</term>
<term>Neoadjuvant Therapy (adverse effects)</term>
<term>Paclitaxel (administration & dosage)</term>
<term>Paclitaxel (adverse effects)</term>
<term>Protein Kinase Inhibitors (administration & dosage)</term>
<term>Protein Kinase Inhibitors (adverse effects)</term>
<term>Receptor, ErbB-2 (antagonists & inhibitors)</term>
<term>Receptor, ErbB-2 (metabolism)</term>
<term>Time Factors</term>
<term>Trastuzumab (administration & dosage)</term>
<term>Trastuzumab (adverse effects)</term>
<term>Treatment Outcome</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Aminopyridines</term>
<term>Morpholines</term>
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<term>Protein Kinase Inhibitors</term>
<term>Trastuzumab</term>
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<term>Morpholines</term>
<term>Paclitaxel</term>
<term>Protein Kinase Inhibitors</term>
<term>Trastuzumab</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
<term>Neoadjuvant Therapy</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Biomarkers, Tumor</term>
<term>Class I Phosphatidylinositol 3-Kinases</term>
<term>Receptor, ErbB-2</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Lymphocytes, Tumor-Infiltrating</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term>
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<term>Class I Phosphatidylinositol 3-Kinases</term>
<term>Ki-67 Antigen</term>
<term>Receptor, ErbB-2</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term>
</keywords>
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</keywords>
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<term>Aged</term>
<term>Australia</term>
<term>Biopsy</term>
<term>Chemotherapy, Adjuvant</term>
<term>Double-Blind Method</term>
<term>Early Termination of Clinical Trials</term>
<term>Europe</term>
<term>Female</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Mutation</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>
</Author>
</AuthorList>
<Language>eng</Language>
<GrantList CompleteYN="Y"><Grant><GrantID>P30 CA008748</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
</GrantList>
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<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>09</Month>
<Day>17</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Eur J Cancer</MedlineTA>
<NlmUniqueID>9005373</NlmUniqueID>
<ISSNLinking>0959-8049</ISSNLinking>
</MedlineJournalInfo>
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</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014408">Biomarkers, Tumor</NameOfSubstance>
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<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C571178">NVP-BKM120</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000631" MajorTopicYN="N">Aminopyridines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
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<MeshHeading><DescriptorName UI="D014408" MajorTopicYN="N">Biomarkers, Tumor</DescriptorName>
<QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName>
<QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName>
<QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D001706" MajorTopicYN="N">Biopsy</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D001943" MajorTopicYN="N">Breast Neoplasms</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000201" MajorTopicYN="N">enzymology</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D056486" MajorTopicYN="N">Chemical and Drug Induced Liver Injury</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017024" MajorTopicYN="N">Chemotherapy, Adjuvant</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D058534" MajorTopicYN="N">Class I Phosphatidylinositol 3-Kinases</DescriptorName>
<QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName>
<QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName>
<QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D057239" MajorTopicYN="N">Early Termination of Clinical Trials</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005060" MajorTopicYN="N">Europe</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D019394" MajorTopicYN="N">Ki-67 Antigen</DescriptorName>
<QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016246" MajorTopicYN="N">Lymphocytes, Tumor-Infiltrating</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009025" MajorTopicYN="N">Morpholines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009154" MajorTopicYN="N">Mutation</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D020360" MajorTopicYN="Y">Neoadjuvant Therapy</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017239" MajorTopicYN="N">Paclitaxel</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D047428" MajorTopicYN="N">Protein Kinase Inhibitors</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018719" MajorTopicYN="N">Receptor, ErbB-2</DescriptorName>
<QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName>
<QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000068878" MajorTopicYN="N">Trastuzumab</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Buparlisib</Keyword>
<Keyword MajorTopicYN="N">HER2</Keyword>
<Keyword MajorTopicYN="N">NeoPHOEBE</Keyword>
<Keyword MajorTopicYN="N">Neoadjuvant</Keyword>
<Keyword MajorTopicYN="N">Primary breast cancer</Keyword>
<Keyword MajorTopicYN="N">pCR</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year>
<Month>04</Month>
<Day>07</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2017</Year>
<Month>08</Month>
<Day>18</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2017</Year>
<Month>08</Month>
<Day>18</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pmc-release"><Year>2018</Year>
<Month>11</Month>
<Day>01</Day>
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<Month>9</Month>
<Day>20</Day>
<Hour>6</Hour>
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<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>10</Month>
<Day>24</Day>
<Hour>6</Hour>
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