First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorRIMAWI, Mothaffar
dc.contributor.authorFERRERO, Jean-Marc
dc.contributor.authorHABA-RODRIGUEZ, Juan de la
dc.contributor.authorPOOLE, Christopher
dc.contributor.authorPLACIDO, Sabino De
dc.contributor.authorOSBORNE, C. Kent
dc.contributor.authorHEGG, Roberto
dc.contributor.authorEASTON, Valerie
dc.contributor.authorWOHLFARTH, Christine
dc.contributor.authorARPINO, Grazia
dc.contributor.groupauthorPERTAIN Study Grp
dc.date.accessioned2019-01-17T13:34:48Z
dc.date.available2019-01-17T13:34:48Z
dc.date.issued2018
dc.description.abstractPurposeTo assess pertuzumab plus trastuzumab and an aromatase inhibitor (AI) in patients with human epidermal growth factor receptor 2 (HER2)-positive and hormone receptor-positive metastatic/locally advanced breast cancer (MBC/LABC).Patients and MethodsThe PERTAIN trial (NCT01491737) is an ongoing randomized, open-label, multicenter80 sites and eight countriesphase II trial. Patients have HER2-positive, hormone receptor-positive MBC/LABC and no prior systemic therapy with the exception of endocrine. Random assignment was 1:1 to intravenous pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) plus trastuzumab (8 mg/kg followed by 6 mg/kg every 3 weeks), and oral anastrozole (1 mg every day) or letrozole (2.5 mg every day), or trastuzumab and an AI. Induction intravenous docetaxel every 3 weeks or paclitaxel every week could be administered for 18 to 24 weeks at the investigator's discretion (decided before but given after random assignment). Primary end point was progression-free survival (PFS). Patients were stratified by whether they received induction chemotherapy and their time since adjuvant hormone therapy.ResultsOne hundred twenty-nine patients were randomly assigned per arm (February 2012 to October 2014; intent-to-treat populations); 75 in one arm and 71 in the other were chosen to receive induction chemotherapy. Stratified median PFS was 18.89 months (95% CI, 14.09 to 27.66 months) in the pertuzumab plus trastuzumab arm and 15.80 months (95% CI, 11.04 to 18.56 months) in the trastuzumab arm (stratified hazard ratio, 0.65; 95% CI, 0.48 to 0.89; P = .0070). Serious adverse events (AEs) were reported for 42 (33.1%) of 127 and 24 (19.4%) of 124 patients in the safety populations of the pertuzumab plus trastuzumab and trastuzumab arms, respectively. Rates of grade 3 AEs were 64 (50.4%) of 127 and 48 (38.7%) of 124, respectively. There were no deaths as a result of AEs.ConclusionPERTAIN met its primary PFS end point. Pertuzumab plus trastuzumab and an AI is effective for the treatment of HER2-positive MBC/LABC. The safety profile was consistent with previous trials of pertuzumab plus trastuzumab.eng
dc.description.indexMEDLINEeng
dc.description.sponsorshipF. Hoffmann-La Roche Ltd.
dc.identifier.citationJOURNAL OF CLINICAL ONCOLOGY, v.36, n.28, p.2826-2835, 2018
dc.identifier.doi10.1200/JCO.2017.76.7863
dc.identifier.eissn1527-7755
dc.identifier.issn0732-183X
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/29994
dc.language.isoeng
dc.publisherAMER SOC CLINICAL ONCOLOGYeng
dc.relation.ispartofJournal of Clinical Oncology
dc.rightsrestrictedAccesseng
dc.rights.holderCopyright AMER SOC CLINICAL ONCOLOGYeng
dc.subject.otherfree chemotherapy regimenseng
dc.subject.otherneoadjuvant pertuzumabeng
dc.subject.otherestrogen-receptoreng
dc.subject.othercardiac safetyeng
dc.subject.otherefficacyeng
dc.subject.othermulticentereng
dc.subject.othercombinationeng
dc.subject.otherdocetaxeleng
dc.subject.othermechanismeng
dc.subject.otherneosphereeng
dc.subject.wosOncologyeng
dc.titleFirst-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trialeng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryItália
hcfmusp.affiliation.countrySuíça
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryFrança
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisofr
hcfmusp.affiliation.countryisoes
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisoit
hcfmusp.affiliation.countryisoch
hcfmusp.author.externalRIMAWI, Mothaffar:Baylor Coll Med, Houston, TX 77030 USA
hcfmusp.author.externalFERRERO, Jean-Marc:Ctr Antoine Lacassagne, Nice, France
hcfmusp.author.externalHABA-RODRIGUEZ, Juan de la:Univ Cordoba, Reina Sofia Hosp, Cordoba, Spain
hcfmusp.author.externalPOOLE, Christopher:Univ Hosp Coventry, Coventry, W Midlands, England; Warwickshire Natl Hlth Serv Trust, Coventry, W Midlands, England
hcfmusp.author.externalPLACIDO, Sabino De:Univ Federico II, Naples, Italy
hcfmusp.author.externalOSBORNE, C. Kent:Baylor Coll Med, Houston, TX 77030 USA
hcfmusp.author.externalEASTON, Valerie:F Hoffmann La Roche Ltd, Basel, Switzerland
hcfmusp.author.externalWOHLFARTH, Christine:F Hoffmann La Roche Ltd, Basel, Switzerland
hcfmusp.author.externalARPINO, Grazia:Univ Federico II, Naples, Italy
hcfmusp.citation.scopus149
hcfmusp.contributor.author-fmusphcROBERTO HEGG
hcfmusp.description.beginpage2826
hcfmusp.description.endpage2835
hcfmusp.description.issue28
hcfmusp.description.volume36
hcfmusp.origemWOS
hcfmusp.origem.pubmed30106636
hcfmusp.origem.scopus2-s2.0-85054148622
hcfmusp.origem.wosWOS:000451485300003
hcfmusp.publisher.cityALEXANDRIAeng
hcfmusp.publisher.countryUSAeng
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