THE ENCHANTTM TRIAL: AN OPEN LABEL MULTICENTER PHASE 2 WINDOW OF OPPORTUNITY STUDY EVALUATING GANETESPIB (STA-9090) MONOTHERAPY IN WOMEN WITH PREVIOUSLY UNTREATED METASTATIC HER2 POSITIVE OR TRIPLE NEGATIVE BREAST CANCER (TNBC)

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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.authorCAMERON, D.
dc.contributor.authorMANO, M. S.
dc.contributor.authorVUKOVIC, V.
dc.contributor.authorTEOFILOVICI, F.
dc.contributor.authorBRADLEY, R.
dc.contributor.authorAWADA, A.
dc.date.accessioned2013-10-11T21:18:22Z
dc.date.available2013-10-11T21:18:22Z
dc.date.issued2012
dc.description.abstractBackground Hsp90 is a molecular chaperone required for proper folding and activation of many cancer-promoting proteins. Several Hsp90 clients are oncoproteins known to play a key role in the pathobiology of breast cancer, including HER2, p95-HER2, EGFR, ER, PI3K, AKT, and VEGFR. The inactivation of these oncoproteins by Hsp90 inhibition is a promising approach for breast cancer therapy. Ganetespib is an Hsp90 inhibitor which has shown anti-tumor activity in heavily pretreated patients with lung, breast, and other cancers. Ganetespib is well tolerated without severe liver or common ocular toxicities. In a phase 2 trial, 22 breast cancer patients who had received up to 3 prior lines of chemotherapy including trastuzumab were treated with ganetespib monotherapy. In patients with HER2+ disease, the objective response rate (ORR) was 15% (2/13) and the SD rate was 46% (6/13). Only 3 patients presented with TNBC; one of those patients achieved SD with substantial tumor shrinkage on treatment. Methods This is a single arm international open-label Phase 2 study in patients with HER2 amplified, or triple negative breast cancer. Patients must not have received any prior therapy in the metastatic setting. Prior adjuvant therapy is allowed. Primary endpoint: ORR. Main secondary endpoints include disease control rate, and progression free survival. Additionally, fresh biopsies and serum samples are collected from all patients for determination of predictors of response and mechanisms of resistance to treatment. Patients are treated with ganetespib 150 mg/m2 is given twice weekly of a 4-week cycle for up to 12 weeks. A total of 70 patients are planned for accrual. At the time of submission, the study is receiving IRB approvals in several centers.
dc.description.conferencedateSEP 28-OCT 02, 2012
dc.description.conferencelocalVienna, AUSTRIA
dc.description.conferencename37th Congress of the European-Society-for-Medical-Oncology (ESMO)
dc.description.indexMEDLINE
dc.identifier.citationANNALS OF ONCOLOGY, v.23, suppl.9, p.125-126, 2012
dc.identifier.issn0923-7534
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/2845
dc.language.isoeng
dc.publisherOXFORD UNIV PRESS
dc.relation.ispartofAnnals of Oncology
dc.rightsrestrictedAccess
dc.rights.holderCopyright OXFORD UNIV PRESS
dc.subject.wosOncology
dc.titleTHE ENCHANTTM TRIAL: AN OPEN LABEL MULTICENTER PHASE 2 WINDOW OF OPPORTUNITY STUDY EVALUATING GANETESPIB (STA-9090) MONOTHERAPY IN WOMEN WITH PREVIOUSLY UNTREATED METASTATIC HER2 POSITIVE OR TRIPLE NEGATIVE BREAST CANCER (TNBC)
dc.typeconferenceObject
dc.type.categorymeeting abstract
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryEscócia
hcfmusp.affiliation.countryBélgica
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisobe
hcfmusp.author.externalCAMERON, D.:Edinburgh Canc CentreWestern Gen Hosp, Edinburgh, Midlothian, Scotland
hcfmusp.author.externalVUKOVIC, V.:Synta Pharmaceut, Oncol, Lexington, MA USA
hcfmusp.author.externalTEOFILOVICI, F.:Synta Pharmaceut, Oncol, Lexington, MA USA
hcfmusp.author.externalBRADLEY, R.:Synta Pharmaceut, Oncol, Lexington, MA USA
hcfmusp.author.externalAWADA, A.:Inst Jules Bordet, Dept Med Oncol, B-1000 Brussels, Belgium
hcfmusp.contributor.author-fmusphcMAX SENNA MANO
hcfmusp.description.beginpage125
hcfmusp.description.endpage126
hcfmusp.description.issuesuppl 9
hcfmusp.description.volume23
hcfmusp.origemWOS
hcfmusp.origem.wosWOS:000309409000341
hcfmusp.publisher.cityOXFORD
hcfmusp.publisher.countryENGLAND
relation.isAuthorOfPublication1541ce2f-dafd-4094-b650-ef95fa7da1e3
relation.isAuthorOfPublication.latestForDiscovery1541ce2f-dafd-4094-b650-ef95fa7da1e3
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