2015
TBCRC009: A Multicenter Phase II Clinical Trial of Platinum Monotherapy With Biomarker Assessment in Metastatic Triple-Negative Breast Cancer
Isakoff SJ, Mayer EL, He L, Traina TA, Carey LA, Krag KJ, Rugo HS, Liu MC, Stearns V, Come SE, Timms KM, Hartman AR, Borger DR, Finkelstein DM, Garber JE, Ryan PD, Winer EP, Goss PE, Ellisen LW. TBCRC009: A Multicenter Phase II Clinical Trial of Platinum Monotherapy With Biomarker Assessment in Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2015, 33: 1902-1909. PMID: 25847936, PMCID: PMC4451173, DOI: 10.1200/jco.2014.57.6660.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsBiomarkers, TumorBRCA1 ProteinBRCA2 ProteinCarboplatinCisplatinClass I Phosphatidylinositol 3-KinasesDrug Administration ScheduleFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticGenomic InstabilityHeterozygoteHumansLoss of HeterozygosityMiddle AgedMutationNeoplasm StagingPhosphatidylinositol 3-KinasesTreatment OutcomeTriple Negative Breast NeoplasmsConceptsMetastatic triple-negative breast cancerGermline BRCA1/2 mutationsPhase II clinical trialTriple-negative breast cancerBRCA1/2 mutationsResponse rateClinical trialsBreast cancerMulticenter phase II clinical trialEnd pointSingle-arm phase II clinical trialCoprimary end pointsExploratory end pointsObjective response ratePIK3CA mutation statusSingle-agent platinumLong-term respondersPlatinum-based chemotherapyIdentification of patientsBRCA1/2 mutation carriersGenomic instability signatureGene expression subtypesP73 gene expressionPlatinum monotherapyMutation carriers
2014
Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study
Liu JF, Barry WT, Birrer M, Lee JM, Buckanovich RJ, Fleming GF, Rimel B, Buss MK, Nattam S, Hurteau J, Luo W, Quy P, Whalen C, Obermayer L, Lee H, Winer EP, Kohn EC, Ivy SP, Matulonis UA. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study. The Lancet Oncology 2014, 15: 1207-1214. PMID: 25218906, PMCID: PMC4294183, DOI: 10.1016/s1470-2045(14)70391-2.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialCisplatinConfidence IntervalsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPhthalazinesPiperazinesQuinazolinesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsProgression-free survivalRecurrent platinum-sensitive ovarian cancerPlatinum-sensitive ovarian cancerPhase 2 studyOvarian cancerOlaparib monotherapyMedian progression-free survivalGermline BRCA statusPhase 2 dosePrimary peritoneal cancerRecurrent ovarian cancerPhase 2 trialPhase 3 trialSide effect profilePhase 1 trialUS academic medical centersPatient-reported outcomesEndometrioid ovarian cancerGermline BRCA1/2 mutationsAnti-angiogenic therapyAnti-angiogenic agentsCombination of olaparibAcademic medical centerNational Cancer InstituteVEGF receptor 1Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors
Balmaña J, Tung N, Isakoff S, Graña B, Ryan P, Saura C, Lowe E, Frewer P, Winer E, Baselga J, Garber J. Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors. Annals Of Oncology 2014, 25: 1656-1663. PMID: 24827126, DOI: 10.1093/annonc/mdu187.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsBRCA1/2 mutationsDay 1Overall objective response rateBID days 1Grade 3 neutropeniaObjective response ratePhase I trialTreatment of patientsGermline BRCA1/2 mutationsColony-stimulating factorWarrants further investigationAdvanced breastHematologic supportMeasurable diseaseOral olaparibAdverse eventsI trialTreatment cohortsLipase elevationCisplatin dosesFrequent gradePreliminary efficacyStandard treatment
2011
P2-19-02: Multidisciplinary Treatment of Pregnancy-Associated Breast Cancer.
Meisel J, Economy K, Zabicki-Calvillo K, Gelber S, Kereakoglow S, Winer E, Partridge A, Mayer E. P2-19-02: Multidisciplinary Treatment of Pregnancy-Associated Breast Cancer. Cancer Research 2011, 71: p2-19-02-p2-19-02. DOI: 10.1158/0008-5472.sabcs11-p2-19-02.Peer-Reviewed Original ResearchFetal outcomesUnderwent surgeryTreatment algorithmBirth weightHormone receptor-positive diseasePregnancy-Associated Breast CancerYoung breast cancer patientsSentinel lymph node biopsyAnthracycline/cyclophosphamideContemporary treatment algorithmsMedian birth weightReceptor-positive diseaseGrowth factor supportDose-dense scheduleLymph node biopsyStandard treatment algorithmBreast cancer patientsVentricular septal defectGermline BRCA1/2 mutationsTime of deliverySignificant adverse effectsMultidisciplinary academic centreApgar scorePreterm deliveryTaxane chemotherapy