Latest Overview of the Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: The Past, the Present and the Future
Identifieur interne : 000640 ( Pmc/Checkpoint ); précédent : 000639; suivant : 000641Latest Overview of the Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: The Past, the Present and the Future
Auteurs : Xiu Chen [République populaire de Chine] ; Di Xu [République populaire de Chine] ; Xingjiang Li [République populaire de Chine] ; Jian Zhang [République populaire de Chine] ; Weilin Xu [République populaire de Chine] ; Junchen Hou [République populaire de Chine] ; Wei Zhang [République populaire de Chine] ; Jinhai Tang [République populaire de Chine]Source :
- Journal of Cancer [ 1837-9664 ] ; 2019.
Abstract
Endocrine resistance in hormone receptor positive breast cancer patients urges us to develop novel approaches such as inhibitors of the cyclin-dependent kinases (CDK) 4/6 to reverse its resistance. Nowadays, three selective CDK4/6 inhibitors (Palbociclib, Ribociclib and Abemaciclib) are approved by Federal Drug Administration and the European Medicines Agency for the treatment of advanced and metastatic HR+/HER2- breast cancer. However, no consistent conclusion has been reached to its application in other types of breast cancer. Therefore, the purpose of our study was to overview the clinical trials about the beneficial effects of Palbociclib, Ribociclib and Abemaciclib in breast cancer with their tolerable adverse effects, and discuss their resistant mechanisms thus looking for useful biomarkers to predict the efficiency of the CDK4/6 inhibitors. The CDK4/6 inhibitors application after the support of preclinic and clinic data will be helpful to provide other alternatively suitable strategies for different types of breast cancer patients.
Url:
DOI: 10.7150/jca.33079
PubMed: 31777590
PubMed Central: 6856891
Affiliations:
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Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Li, Xingjiang" sort="Li, Xingjiang" uniqKey="Li X" first="Xingjiang" last="Li">Xingjiang Li</name><affiliation wicri:level="1"><nlm:aff id="A2">Changzhou Wujin People's Hospital, Changzhou, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Changzhou Wujin People's Hospital, Changzhou, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Jian" sort="Zhang, Jian" uniqKey="Zhang J" first="Jian" last="Zhang">Jian Zhang</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Xu, Weilin" sort="Xu, Weilin" uniqKey="Xu W" first="Weilin" last="Xu">Weilin Xu</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Hou, Junchen" sort="Hou, Junchen" uniqKey="Hou J" first="Junchen" last="Hou">Junchen Hou</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Wei" sort="Zhang, Wei" uniqKey="Zhang W" first="Wei" last="Zhang">Wei Zhang</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical 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when="2019">2019</date><idno type="wicri:Area/Pmc/Corpus">000A45</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000A45</idno><idno type="wicri:Area/Pmc/Curation">000A45</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000A45</idno><idno type="wicri:Area/Pmc/Checkpoint">000640</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000640</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Latest Overview of the Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: The Past, the Present and the Future</title><author><name sortKey="Chen, Xiu" sort="Chen, Xiu" uniqKey="Chen X" first="Xiu" last="Chen">Xiu Chen</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Xu, Di" sort="Xu, Di" uniqKey="Xu D" first="Di" last="Xu">Di Xu</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Li, Xingjiang" sort="Li, Xingjiang" uniqKey="Li X" first="Xingjiang" last="Li">Xingjiang Li</name><affiliation wicri:level="1"><nlm:aff id="A2">Changzhou Wujin People's Hospital, Changzhou, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Changzhou Wujin People's Hospital, Changzhou, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Jian" sort="Zhang, Jian" uniqKey="Zhang J" first="Jian" last="Zhang">Jian Zhang</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Xu, Weilin" sort="Xu, Weilin" uniqKey="Xu W" first="Weilin" last="Xu">Weilin Xu</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Hou, Junchen" sort="Hou, Junchen" uniqKey="Hou J" first="Junchen" last="Hou">Junchen Hou</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Wei" sort="Zhang, Wei" uniqKey="Zhang W" first="Wei" last="Zhang">Wei Zhang</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author><author><name sortKey="Tang, Jinhai" sort="Tang, Jinhai" uniqKey="Tang J" first="Jinhai" last="Tang">Jinhai Tang</name><affiliation wicri:level="1"><nlm:aff id="A1">Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</nlm:aff><country xml:lang="fr" wicri:curation="lc">République populaire de Chine</country><wicri:regionArea>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu</wicri:regionArea><wicri:noRegion>Jiangsu</wicri:noRegion></affiliation></author></analytic><series><title level="j">Journal of Cancer</title><idno type="eISSN">1837-9664</idno><imprint><date when="2019">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Endocrine resistance in hormone receptor positive breast cancer patients urges us to develop novel approaches such as inhibitors of the cyclin-dependent kinases (CDK) 4/6 to reverse its resistance. Nowadays, three selective CDK4/6 inhibitors (Palbociclib, Ribociclib and Abemaciclib) are approved by Federal Drug Administration and the European Medicines Agency for the treatment of advanced and metastatic HR+/HER2- breast cancer. However, no consistent conclusion has been reached to its application in other types of breast cancer. Therefore, the purpose of our study was to overview the clinical trials about the beneficial effects of Palbociclib, Ribociclib and Abemaciclib in breast cancer with their tolerable adverse effects, and discuss their resistant mechanisms thus looking for useful biomarkers to predict the efficiency of the CDK4/6 inhibitors. The CDK4/6 inhibitors application after the support of preclinic and clinic data will be helpful to provide other alternatively suitable strategies for different types of breast cancer patients.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Steger, G G" uniqKey="Steger G">G G Steger</name></author><author><name sortKey="Gnant, M" uniqKey="Gnant M">M Gnant</name></author><author><name sortKey="Bartsch, R" uniqKey="Bartsch R">R Bartsch</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rugo, Hs" uniqKey="Rugo H">HS Rugo</name></author><author><name sortKey="Vidula, N" uniqKey="Vidula N">N Vidula</name></author><author><name sortKey="Ma, C" uniqKey="Ma C">C Ma</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Demichele, A" uniqKey="Demichele A">A DeMichele</name></author><author><name sortKey="Clark, As" uniqKey="Clark A">AS Clark</name></author><author><name 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<front><journal-meta><journal-id journal-id-type="nlm-ta">J Cancer</journal-id><journal-id journal-id-type="iso-abbrev">J Cancer</journal-id><journal-id journal-id-type="publisher-id">jca</journal-id><journal-title-group><journal-title>Journal of Cancer</journal-title></journal-title-group><issn pub-type="epub">1837-9664</issn><publisher><publisher-name>Ivyspring International Publisher</publisher-name><publisher-loc>Sydney</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">31777590</article-id><article-id pub-id-type="pmc">6856891</article-id><article-id pub-id-type="doi">10.7150/jca.33079</article-id><article-id pub-id-type="publisher-id">jcav10p6608</article-id><article-categories><subj-group subj-group-type="heading"><subject>Review</subject></subj-group></article-categories><title-group><article-title>Latest Overview of the Cyclin-Dependent Kinases 4/6 Inhibitors in Breast Cancer: The Past, the Present and the Future</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Chen</surname><given-names>Xiu</given-names></name><xref ref-type="aff" rid="A1">1</xref><xref ref-type="author-notes" rid="FNA_star">*</xref></contrib><contrib contrib-type="author"><name><surname>Xu</surname><given-names>Di</given-names></name><xref ref-type="aff" rid="A1">1</xref><xref ref-type="author-notes" rid="FNA_star">*</xref></contrib><contrib contrib-type="author"><name><surname>Li</surname><given-names>Xingjiang</given-names></name><xref ref-type="aff" rid="A2">2</xref><xref ref-type="author-notes" rid="FNA_star">*</xref></contrib><contrib contrib-type="author"><name><surname>Zhang</surname><given-names>Jian</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Xu</surname><given-names>Weilin</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Hou</surname><given-names>Junchen</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Zhang</surname><given-names>Wei</given-names></name><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Tang</surname><given-names>Jinhai</given-names></name><xref ref-type="aff" rid="A1">1</xref><xref ref-type="corresp" rid="FNA_envelop">✉</xref></contrib></contrib-group><aff id="A1"><label>1</label>Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.</aff><aff id="A2"><label>2</label>Changzhou Wujin People's Hospital, Changzhou, Jiangsu, China.</aff><author-notes><corresp id="FNA_envelop">✉ Corresponding author: Jinhai Tang, Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University, Guangzhou Road 300, Nanjing, Jiangsu, 210029, China. Email: <email>jhtang@njmu.edu.cn</email></corresp><fn fn-type="equal" id="FNA_star"><p>* Contributing equally to this article</p></fn><fn fn-type="COI-statement"><p>Competing Interests: The authors have declared that no competing interest exists.</p></fn></author-notes><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>21</day><month>10</month><year>2019</year></pub-date><volume>10</volume><issue>26</issue><fpage>6608</fpage><lpage>6617</lpage><history><date date-type="received"><day>13</day><month>1</month><year>2019</year></date><date date-type="accepted"><day>26</day><month>8</month><year>2019</year></date></history><permissions><copyright-statement>© The author(s)</copyright-statement><copyright-year>2019</copyright-year><license license-type="open-access"><license-p>This is an open access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">https://creativecommons.org/licenses/by/4.0/</ext-link>). See <ext-link ext-link-type="uri" xlink:href="http://ivyspring.com/terms">http://ivyspring.com/terms</ext-link> for full terms and conditions.</license-p></license></permissions><abstract><p>Endocrine resistance in hormone receptor positive breast cancer patients urges us to develop novel approaches such as inhibitors of the cyclin-dependent kinases (CDK) 4/6 to reverse its resistance. Nowadays, three selective CDK4/6 inhibitors (Palbociclib, Ribociclib and Abemaciclib) are approved by Federal Drug Administration and the European Medicines Agency for the treatment of advanced and metastatic HR+/HER2- breast cancer. However, no consistent conclusion has been reached to its application in other types of breast cancer. Therefore, the purpose of our study was to overview the clinical trials about the beneficial effects of Palbociclib, Ribociclib and Abemaciclib in breast cancer with their tolerable adverse effects, and discuss their resistant mechanisms thus looking for useful biomarkers to predict the efficiency of the CDK4/6 inhibitors. The CDK4/6 inhibitors application after the support of preclinic and clinic data will be helpful to provide other alternatively suitable strategies for different types of breast cancer patients.</p></abstract><kwd-group><kwd>breast cancer</kwd><kwd>drug</kwd><kwd>cyclin-dependent kinases 4/6 inhibitors</kwd><kwd>adjuvant therapy</kwd><kwd>neoadjuvant therapy</kwd></kwd-group></article-meta></front><floats-group><table-wrap id="T1" position="float"><label>Table 1</label><caption><p>Studies of Palbociclib</p></caption><table frame="hsides" rules="groups"><thead valign="top"><tr><th rowspan="1" colspan="1">Study name/ID</th><th rowspan="1" colspan="1">Phase</th><th rowspan="1" colspan="1">Subtype</th><th rowspan="1" colspan="1">Prior treatment</th><th rowspan="1" colspan="1">Allocation</th><th rowspan="1" colspan="1">Number</th><th rowspan="1" colspan="1">Combination drugs</th><th rowspan="1" colspan="1">Aims</th></tr></thead><tbody valign="top"><tr><td rowspan="1" colspan="1">PATHWAY/<break></break>NCT03423199</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">180</td><td rowspan="1" colspan="1">Tamoxifen ± Goserelin</td><td rowspan="1" colspan="1">PFS,OS</td></tr><tr><td rowspan="1" colspan="1">PASIPHAE/<break></break>NCT03322215</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">endocrine</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">196</td><td rowspan="1" colspan="1">Fulvestrant</td><td rowspan="1" colspan="1">PFS,OS</td></tr><tr><td rowspan="1" colspan="1">INGE-B/<break></break>NCT02894398</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">360</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">CBR</td></tr><tr><td rowspan="1" colspan="1">NCT02668666</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">71</td><td rowspan="1" colspan="1">Tamoxifen</td><td rowspan="1" colspan="1">Response Rates,PFS,CBR,OS</td></tr><tr><td rowspan="1" colspan="1">PRECYCLE/<break></break>NCT03220178</td><td rowspan="1" colspan="1">4</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">960</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">DQoL,PFS, OS</td></tr><tr><td rowspan="1" colspan="1">NCT03425838</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">1050</td><td rowspan="1" colspan="1">AI or Fulvestrant</td><td rowspan="1" colspan="1">PFS2,OS</td></tr><tr><td rowspan="1" colspan="1">PYTHIA/<break></break>NCT02536742</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- MBC</td><td rowspan="1" colspan="1">endocrine</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">120</td><td rowspan="1" colspan="1">Fulvestrant</td><td rowspan="1" colspan="1">PFS</td></tr><tr><td rowspan="1" colspan="1">NCT02384239</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">70</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">Tumor Progression,PFS</td></tr><tr><td rowspan="1" colspan="1">PACE/<break></break>NCT03147287</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- MBC</td><td rowspan="1" colspan="1">endocrine</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">220</td><td rowspan="1" colspan="1">Fulvestrant and Avelumab or Fulvestrant</td><td rowspan="1" colspan="1">PFS,OSR</td></tr><tr><td rowspan="1" colspan="1">PATRICIA/<break></break>NCT02448420</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2+ MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">138</td><td rowspan="1" colspan="1">None</td><td rowspan="1" colspan="1">PFS</td></tr><tr><td rowspan="1" colspan="1">PATINA/<break></break>NCT02947685</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2+ MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">496</td><td rowspan="1" colspan="1">None</td><td rowspan="1" colspan="1">PFS,OS</td></tr><tr><td rowspan="1" colspan="1">PALLAS/<break></break>NCT02513394</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- EBC</td><td rowspan="1" colspan="1">neo/adjuvant therapy</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">5600</td><td rowspan="1" colspan="1">standard adjuvant endocrine therapy</td><td rowspan="1" colspan="1">iDFS,DRFS,LRRFS,OS</td></tr><tr><td rowspan="1" colspan="1">NCT02605486</td><td rowspan="1" colspan="1">1,2</td><td rowspan="1" colspan="1">AR+ MBC</td><td rowspan="1" colspan="1">endocrine or chemotherapy</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">51</td><td rowspan="1" colspan="1">Bicalutamide</td><td rowspan="1" colspan="1">PFS,Toxicity assessment</td></tr><tr><td rowspan="1" colspan="1">BRE15-024/<break></break>NCT03090165</td><td rowspan="1" colspan="1">1,2</td><td rowspan="1" colspan="1">AR+ TNBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">58</td><td rowspan="1" colspan="1">Bicalutamide</td><td rowspan="1" colspan="1">CBR,ORR</td></tr><tr><td rowspan="1" colspan="1">NCT02600923</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">130</td><td rowspan="1" colspan="1">Letrozole</td><td rowspan="1" colspan="1">AE</td></tr><tr><td rowspan="1" colspan="1">NCT02679755</td><td rowspan="1" colspan="1">4</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">300</td><td rowspan="1" colspan="1">Letrozole</td><td rowspan="1" colspan="1">AE</td></tr><tr><td rowspan="1" colspan="1">NCT02626507</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">ER+/HER2- BC</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">18</td><td rowspan="1" colspan="1">None</td><td rowspan="1" colspan="1">AE</td></tr><tr><td rowspan="1" colspan="1">PALINA/<break></break>NCT02692755</td><td rowspan="1" colspan="1">2,3</td><td rowspan="1" colspan="1">HR+/HER2- BC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">35</td><td rowspan="1" colspan="1">Letrozole or Fulvestrant</td><td rowspan="1" colspan="1">AE</td></tr><tr><td rowspan="1" colspan="1">NCT03401359</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">HR+ MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">100</td><td rowspan="1" colspan="1">Endocrine</td><td rowspan="1" colspan="1">Biomarker of acquired resistance</td></tr><tr><td rowspan="1" colspan="1">NCT03238196</td><td rowspan="1" colspan="1">1b</td><td rowspan="1" colspan="1">ER+/HER2-/FGFR-amplified MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">32</td><td rowspan="1" colspan="1">Fulvestrant and Erdafitinib</td><td rowspan="1" colspan="1">AE,DLT,MTD,Next Generation Sequencing</td></tr><tr><td rowspan="1" colspan="1">NCT02774681</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR-/HER2+ MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Single group</td><td rowspan="1" colspan="1">12</td><td rowspan="1" colspan="1">Trastuzumab</td><td rowspan="1" colspan="1">Radiographic response rate in the CNS,AE,OS,PFS,ORR</td></tr><tr><td rowspan="1" colspan="1">NCT03304080</td><td rowspan="1" colspan="1">1/2</td><td rowspan="1" colspan="1">HR+/HER2+ MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Single group</td><td rowspan="1" colspan="1">36</td><td rowspan="1" colspan="1">Anastrozole, Trastuzumab, Pertuzumab</td><td rowspan="1" colspan="1">DLT,MTD,CBR,PFS,AE</td></tr><tr><td rowspan="1" colspan="1">NCT03065387</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">HER2 Mutation or Amplification</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">120</td><td rowspan="1" colspan="1">Neratinib</td><td rowspan="1" colspan="1">MTD</td></tr><tr><td rowspan="1" colspan="1">NCT03054363</td><td rowspan="1" colspan="1">1b/2</td><td rowspan="1" colspan="1">HR+/HER2+ MBC</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Single group</td><td rowspan="1" colspan="1">25</td><td rowspan="1" colspan="1">Tucatinib, Letrozole</td><td rowspan="1" colspan="1">AE,PFS</td></tr><tr><td rowspan="1" colspan="1">PALTAN/<break></break>NCT02907918</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">Stage II-III ER+/HER2+ BC</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">Single group</td><td rowspan="1" colspan="1">48</td><td rowspan="1" colspan="1">Letrozole, Trastuzumab, or Goserelin</td><td rowspan="1" colspan="1">Response Rates, AE, Outcomes</td></tr></tbody></table><table-wrap-foot><fn><p>CBR: Clinical Benefit Rate; PFS: Progression Free Survival; iDFS: Invasive Disease Free Survival; DRFS: Distant Recurrence-free Survival; LRRFS: Locoregional Recurrences-free Survival; OS: Overall Survival; ORR: Objective Response Rate; PFS2: Progression-free survival after two lines of treatment; PFS6: Progression-Free Survival at 6 months; DLT: dose limiting toxicity; MTD: Maximum Tolerated Dose.</p></fn></table-wrap-foot></table-wrap><table-wrap id="T2" position="float"><label>Table 2</label><caption><p>Studies of Ribociclib</p></caption><table frame="hsides" rules="groups"><thead valign="top"><tr><th rowspan="1" colspan="1">Study name/ID</th><th rowspan="1" colspan="1">Phase</th><th rowspan="1" colspan="1">Subtype</th><th rowspan="1" colspan="1">Prior treatment</th><th rowspan="1" colspan="1">Allocation</th><th rowspan="1" colspan="1">Number</th><th rowspan="1" colspan="1">Combination drugs</th><th rowspan="1" colspan="1">Aims</th></tr></thead><tbody valign="top"><tr><td rowspan="1" colspan="1">NCT03671330</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">315</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">PFS</td></tr><tr><td rowspan="1" colspan="1">MONALEESA-2/<break></break>NCT01958021</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">none</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">670</td><td rowspan="1" colspan="1">Letrozole</td><td rowspan="1" colspan="1">PFS,OS,ORR,CBR</td></tr><tr><td rowspan="1" colspan="1">NCT02712723</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">120</td><td rowspan="1" colspan="1">Letrozole</td><td rowspan="1" colspan="1">PEPI rate, pCR</td></tr><tr><td rowspan="1" colspan="1">NCT03096847</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">500</td><td rowspan="1" colspan="1">None</td><td rowspan="1" colspan="1">CBR,PFS</td></tr><tr><td rowspan="1" colspan="1">AMICA/<break></break>NCT03555877</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2- MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">150</td><td rowspan="1" colspan="1">None</td><td rowspan="1" colspan="1">PFS,OS,CBR</td></tr><tr><td rowspan="1" colspan="1">RIBBIT/<break></break>NCT03462251</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">160</td><td rowspan="1" colspan="1">None</td><td rowspan="1" colspan="1">PFS,OS,CBR</td></tr><tr><td rowspan="1" colspan="1">LEADER/<break></break>NCT03285412</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">ER+ EBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">120</td><td rowspan="1" colspan="1">Endocrine</td><td rowspan="1" colspan="1">AE, DFS</td></tr><tr><td rowspan="1" colspan="1">NCT02599363</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">Rb+ ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">28</td><td rowspan="1" colspan="1">None</td><td rowspan="1" colspan="1">AE</td></tr><tr><td rowspan="1" colspan="1">MAINTAIN/<break></break>NCT02632045</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+ HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">132</td><td rowspan="1" colspan="1">Fulvestrant</td><td rowspan="1" colspan="1">ORR</td></tr><tr><td rowspan="1" colspan="1">TRINITI-1 trial/<break></break>NCT01857193</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">ER+/HER2- ABC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">132</td><td rowspan="1" colspan="1">Everolimus and Exemestane or Exemestane</td><td rowspan="1" colspan="1">DLT,safety and tolerability</td></tr><tr><td rowspan="1" colspan="1">NCT02657343</td><td rowspan="1" colspan="1">1b/2</td><td rowspan="1" colspan="1">HER2+ ABC/MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">86</td><td rowspan="1" colspan="1">T-DM1 or Trastuzumab or Fulvestrant</td><td rowspan="1" colspan="1">MTD,ORR,PFS,OS</td></tr></tbody></table><table-wrap-foot><fn><p>CBR: Clinical Benefit Rate; PFS: Progression Free Survival; iDFS: Invasive Disease Free Survival; DRFS: Distant Recurrence-free Survival; LRRFS: Locoregional Recurrences-free Survival; OS: Overall Survival; ORR: Objective Response Rate; DLT: dose limiting toxicity; PEPI: Pre-operative Endocrine Prognostic Index.</p></fn></table-wrap-foot></table-wrap><table-wrap id="T3" position="float"><label>Table 3</label><caption><p>Studies of Abemaciclib</p></caption><table frame="hsides" rules="groups"><thead valign="top"><tr><th rowspan="1" colspan="1">Study name/ID</th><th rowspan="1" colspan="1">Phase</th><th rowspan="1" colspan="1">Subtype</th><th rowspan="1" colspan="1">Prior treatment</th><th rowspan="1" colspan="1">Allocation</th><th rowspan="1" colspan="1">Number</th><th rowspan="1" colspan="1">Combination drugs</th><th rowspan="1" colspan="1">Aims</th></tr></thead><tbody valign="top"><tr><td rowspan="1" colspan="1">NCT03130439</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">Rb+ TNMBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">37</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">ORR,PFS,OS,DFS</td></tr><tr><td rowspan="1" colspan="1">monarchE/NCT03155997</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">HR+/HER2- MBC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">4580</td><td rowspan="1" colspan="1">standard adjuvant endocrine therapy</td><td rowspan="1" colspan="1">IDFS</td></tr><tr><td rowspan="1" colspan="1">NCT02057133</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">BC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">198</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">AE</td></tr><tr><td rowspan="1" colspan="1">NCT02779751</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">BC</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Non-Randomized</td><td rowspan="1" colspan="1">100</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">AE</td></tr><tr><td rowspan="1" colspan="1">monarcHER/NCT02675231</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">HR+/HER2+ MBC</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Randomized</td><td rowspan="1" colspan="1">225</td><td rowspan="1" colspan="1">Trastuzumab, Fulvestrant</td><td rowspan="1" colspan="1">PFS,OS</td></tr></tbody></table><table-wrap-foot><fn><p>PFS: Progression Free Survival; IDFS: Invasive Disease Free Survival; OS: Overall Survival; ORR: Objective Response Rate</p></fn></table-wrap-foot></table-wrap></floats-group></pmc><affiliations><list><country><li>République populaire de Chine</li></country></list><tree><country name="République populaire de Chine"><noRegion><name sortKey="Chen, Xiu" sort="Chen, Xiu" uniqKey="Chen X" first="Xiu" last="Chen">Xiu Chen</name></noRegion><name sortKey="Hou, Junchen" sort="Hou, Junchen" uniqKey="Hou J" first="Junchen" last="Hou">Junchen Hou</name><name sortKey="Li, Xingjiang" sort="Li, Xingjiang" uniqKey="Li X" first="Xingjiang" last="Li">Xingjiang Li</name><name sortKey="Tang, Jinhai" sort="Tang, Jinhai" uniqKey="Tang J" first="Jinhai" last="Tang">Jinhai Tang</name><name sortKey="Xu, Di" sort="Xu, Di" uniqKey="Xu D" first="Di" last="Xu">Di Xu</name><name sortKey="Xu, Weilin" sort="Xu, Weilin" uniqKey="Xu W" first="Weilin" last="Xu">Weilin Xu</name><name sortKey="Zhang, Jian" sort="Zhang, Jian" uniqKey="Zhang J" first="Jian" last="Zhang">Jian Zhang</name><name sortKey="Zhang, Wei" sort="Zhang, Wei" uniqKey="Zhang W" first="Wei" last="Zhang">Wei Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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