2023
Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study
Schmid P, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Mejia J, Zhou X, Haiderali A, Nguyen A, Cortes J, Winer E. Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study. European Journal Of Cancer 2023, 195: 113393. PMID: 37976633, DOI: 10.1016/j.ejca.2023.113393.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerCombined positive scoreMetastatic triple-negative breast cancerPD-L1 combined positive scoreHealth-related qualityBreast cancerQLQ-C30 functional scalesTumor PD-L1 expressionGHS/QoLNausea/vomitingPD-L1 expressionStart of treatmentHRQoL resultsEligible patientsHRQoL analysisOverall survivalSystemic therapyClinical outcomesFunctional scalesPhysician's choicePatientsChemotherapyFirst onsetCountry guidelinesMedian TTD
2018
A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer
Schöffski P, Cresta S, Mayer IA, Wildiers H, Damian S, Gendreau S, Rooney I, Morrissey KM, Spoerke JM, Ng VW, Singel SM, Winer E. A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer. Breast Cancer Research 2018, 20: 109. PMID: 30185228, PMCID: PMC6125885, DOI: 10.1186/s13058-018-1015-x.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityPhase Ib studyMetastatic breast cancerAdverse eventsBreast cancerIb studyResultsSixty-nine patientsAntitumor activityManageable safety profileAdvanced breast cancerSerious adverse eventsPreliminary antitumor activityDrug-drug interactionsEvaluation of safetySecondary endpointsPartial responseComplete responseDose escalationRandomized studySafety profilePatientsBevacizumabTrastuzumabPictilisibLetrozole
2013
A Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer
Liu JF, Tolaney SM, Birrer M, Fleming GF, Buss MK, Dahlberg SE, Lee H, Whalen C, Tyburski K, Winer E, Ivy P, Matulonis UA. A Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer. European Journal Of Cancer 2013, 49: 2972-2978. PMID: 23810467, PMCID: PMC3956307, DOI: 10.1016/j.ejca.2013.05.020.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapsulesCarcinoma, Ovarian EpithelialDiarrheaDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleHumansMiddle AgedNauseaNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneReceptors, Vascular Endothelial Growth FactorTabletsTreatment OutcomeConceptsTriple-negative breast cancerOvarian cancer patientsOverall response rateCombination of cediranibCancer patientsBreast cancerDose levelsMetastatic triple-negative breast cancerEvaluable breast cancer patientsPARP inhibitorsClinical benefit rateGrade 3 fatigueGrade 3 hypertensionPhase 2 dosingVascular endothelial growth factor receptorResponse Evaluation CriteriaSolid Tumors 1.1Endothelial growth factor receptorPhase 1 trialBreast cancer patientsDose-escalation designHighest dose levelPolymerase inhibitor olaparibCA125 criteriaGrowth factor receptor
2007
Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study
Burstein HJ, Keshaviah A, Baron AD, Hart RD, Lambert‐Falls R, Marcom PK, Gelman R, Winer EP. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study. Cancer 2007, 110: 965-972. PMID: 17614302, DOI: 10.1002/cncr.22885.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlopeciaAnemiaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsConstipationDisease ProgressionDrug Administration ScheduleFatigueFemaleHumansKaplan-Meier EstimateMiddle AgedNauseaNeoplasm MetastasisPaclitaxelProspective StudiesReceptor, ErbB-2TrastuzumabTreatment OutcomeVinblastineVinorelbineConceptsMetastatic breast cancerBreast cancerTrastuzumab armEpisodes of cardiotoxicityFirst-line therapyDermatologic toxicitiesEvaluable patientsPrior chemotherapyVinorelbine therapyAdvanced diseaseChemotherapy regimenEligible patientsGastrointestinal toxicityPoor accrualTaxane chemotherapyTaxane therapyMore anemiaMedian timeTrastuzumab treatmentFluid retentionDisease progressionChemotherapy agentsTreatment decisionsVinorelbineSide effects