2019
A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer
Abramson VG, Oliveira M, Cervantes A, Wildiers H, Patel MR, Bauer TM, Bedard PL, Becerra C, Richey S, Wei MC, Reyner E, Bond J, Cui N, Wilson TR, Moore HM, Saura C, Krop IE. A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer. Breast Cancer Research And Treatment 2019, 178: 121-133. PMID: 31368034, DOI: 10.1007/s10549-019-05360-3.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinoma, Non-Small-Cell LungClass I Phosphatidylinositol 3-KinasesDocetaxelFemaleHumansImidazolesLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMutationNeoplasm MetastasisOxazepinesPaclitaxelReceptor, ErbB-2Survival AnalysisTreatment OutcomeConceptsNon-small cell lung cancerDose-limiting toxicityMetastatic breast cancerAdverse eventsBreast cancerPhase IbClinical benefit rateDose-expansion studyObjective response ratePhase II doseSerious adverse eventsDose-escalation studyCell lung cancerBenefit-risk profileDays on/2ResultsEighty patientsPrimary endpointSecondary endpointsSafety profileLung cancerBenefit ratePatientsSingle agentResponse rateDocetaxel
2010
Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy
Burris HA, Rugo HS, Vukelja SJ, Vogel CL, Borson RA, Limentani S, Tan-Chiu E, Krop IE, Michaelson RA, Girish S, Amler L, Zheng M, Chu YW, Klencke B, O'Shaughnessy JA. Phase II Study of the Antibody Drug Conjugate Trastuzumab-DM1 for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) –Positive Breast Cancer After Prior HER2-Directed Therapy. Journal Of Clinical Oncology 2010, 29: 398-405. PMID: 21172893, DOI: 10.1200/jco.2010.29.5865.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBreast NeoplasmsDisease-Free SurvivalFemaleHumansImmunotoxinsKaplan-Meier EstimateMaytansineMiddle AgedReceptor, ErbB-2RNA, MessengerTime FactorsTrastuzumabTreatment OutcomeUnited StatesConceptsHER2-positive metastatic breast cancerMetastatic breast cancerPhase II studyTrastuzumab-DM1II studyAdverse eventsResponse rateBreast cancerHER2 levelsMedian progression-free survival timeSingle-arm phase II studyRobust single-agent activityProgression-free survival timeHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorHER2-directed therapiesMaximum-tolerated doseMost adverse eventsObjective response ratePhase II doseGrowth factor receptor 2Single-agent activityHER2-positive tumorsReverse transcriptase-polymerase chain reaction