2022
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. New England Journal Of Medicine 2022, 386: 942-950. PMID: 35263519, DOI: 10.1056/nejmoa2114663.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerSignificant overall survival benefitMedian overall survivalOverall survival benefitProgression-free survivalOverall survivalBreast cancerSurvival benefitHER2-negative advanced breast cancerKey secondary end pointProtocol-specified final analysisLonger progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Negative advanced breast cancerStratified log-rank testFirst-line ribociclibSecondary end pointsFirst-line therapyNew safety signalsPhase 3 trialGrowth factor receptor 2Kaplan-Meier methodLog-rank testFactor receptor 2Phase 1b Clinical Trial with Alpelisib plus Olaparib for Patients with Advanced Triple-Negative Breast CancerAlpelisib plus Olaparib for Triple-Negative Breast Cancer
Batalini F, Xiong N, Tayob N, Polak M, Eismann J, Cantley LC, Shapiro GI, Adalsteinsson V, Winer EP, Konstantinopoulos PA, D'Andrea A, Swisher EM, Matulonis UA, Wulf GM, Mayer EL. Phase 1b Clinical Trial with Alpelisib plus Olaparib for Patients with Advanced Triple-Negative Breast CancerAlpelisib plus Olaparib for Triple-Negative Breast Cancer. Clinical Cancer Research 2022, 28: 1493-1499. PMID: 35149538, PMCID: PMC9066379, DOI: 10.1158/1078-0432.ccr-21-3045.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerObjective response rateCirculating-free DNABreast cancerCommon treatment-related grade 3Treatment-related grade 3Longer progression-free survivalRecurrent triple-negative breast cancerHigh-grade serous ovarian cancerPARP inhibitionPhase 1b clinical trialPhase 2 dosePhase 1b trialSecondary end pointsProgression-free survivalRecurrent breast cancerGermline BRCA mutationsImportant prognostic informationSerous ovarian cancerBreast cancer cohortBRCA-mutant tumorsNon-BRCA carriersPI3K inhibitorsEligible patientsExpansion cohort
2020
Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer
Barroso-Sousa R, Keenan TE, Pernas S, Exman P, Jain E, Garrido-Castro AC, Hughes M, Bychkovsky B, Umeton R, Files JL, Lindeman NI, MacConaill LE, Hodi FS, Krop IE, Dillon D, Winer EP, Wagle N, Lin NU, Mittendorf EA, Van Allen EM, Tolaney SM. Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2020, 26: 2565-2572. PMID: 32019858, PMCID: PMC7269810, DOI: 10.1158/1078-0432.ccr-19-3507.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerHigh tumor mutational burdenProgression-free survivalTumor mutational burdenObjective response rateImmune checkpoint inhibitorsAnti-PD-1/L1 therapyTriple-negative breast cancerOverall survivalL1 therapyPD-L1Breast cancerMutational burdenLow objective response rateLonger progression-free survivalShorter progression-free survivalDana-Farber Cancer InstituteTumor genomic featuresShorter overall survivalMutations/megabaseCheckpoint inhibitorsVisceral metastasesL1 blockadePerformance statusPrior lines
2017
Phase II and Biomarker Study of Cabozantinib in Metastatic Triple‐Negative Breast Cancer Patients
Tolaney SM, Ziehr DR, Guo H, Ng MR, Barry WT, Higgins MJ, Isakoff SJ, Brock JE, Ivanova EV, Paweletz CP, Demeo MK, Ramaiya NH, Overmoyer BA, Jain RK, Winer EP, Duda DG. Phase II and Biomarker Study of Cabozantinib in Metastatic Triple‐Negative Breast Cancer Patients. The Oncologist 2017, 22: 25-32. PMID: 27789775, PMCID: PMC5313267, DOI: 10.1634/theoncologist.2016-0229.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnilidesBiomarkers, TumorDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisPlacenta Growth FactorProtein Kinase InhibitorsProto-Oncogene Proteins c-metPyridinesTriple Negative Breast NeoplasmsVascular Endothelial Growth Factor DVascular Endothelial Growth Factor Receptor-2ConceptsProgression-free survivalVascular endothelial growth factorBreast cancer patientsStable diseasePrimary endpointPartial responseCancer patientsBreast cancerMetastatic triple-negative breast cancer patientsMedian progression-free survivalSingle-arm phase IILonger progression-free survivalTriple-negative breast cancer patientsSoluble VEGF receptor 2Plasma placental growth factorTriple-negative breast cancerBiomarker studiesGrowth factorClinical benefit rateCytotoxic lymphocyte populationsGrade 4 toxicityObjective response ratePalmar-plantar erythrodysesthesiaSubset of patientsStromal cell-derived factor 1a
2013
Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515).
Lin N, Danso M, David A, Muscato J, Rayson D, Houck W, Ellis C, DeSilvio M, Garofalo A, Levin J, Winer E. Human epidermal growth factor receptor 2 (HER2) suppression with the addition of lapatinib to trastuzumab in HER2-positive metastatic breast cancer (HALT: LPT112515). Journal Of Clinical Oncology 2013, 31: tps664-tps664. DOI: 10.1200/jco.2013.31.15_suppl.tps664.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerBreast cancerOverall survivalMetastatic BCPFS eventsStage II/III breast cancerHigher pathologic complete response rateHER2-positive metastatic breast cancerMedian progression-free survivalPathologic complete response rateLonger progression-free survivalAssociated hazard ratiosClinical benefit rateDual HER2 blockadeStable brain metastasesComplete response rateSecond-line treatmentHormone receptor statusPhase III studyAddition of lapatinibLine of treatmentChemotherapy discontinuationEligible patientsHER2 blockade
2011
P2-09-07: Metabolic Response by FDG-PET in Patients (pts) Receiving Trastuzumab (T) and Lapatinib (L) for HER2+ Metastatic Breast Cancer (MBC): Correlative Analysis of TBCRC 003.
Yap J, Locascio T, Najita J, Mayer I, Hobday T, Falkson C, Dees E, Gelman R, Rimawi M, Nanda R, Berkowitz J, Franchetti Y, Wolff A, Winer E, Lin N, Van den Abbeele A. P2-09-07: Metabolic Response by FDG-PET in Patients (pts) Receiving Trastuzumab (T) and Lapatinib (L) for HER2+ Metastatic Breast Cancer (MBC): Correlative Analysis of TBCRC 003. Cancer Research 2011, 71: p2-09-07-p2-09-07. DOI: 10.1158/0008-5472.sabcs11-p2-09-07.Peer-Reviewed Original ResearchMedian progression-free survivalProgression-free survivalMetastatic breast cancerClinical benefitCohort 2Cohort 1FDG-PETWk 8Objective responsePrior linesClinical outcomesMetabolic responseTarget lesionsWk 1Longer progression-free survivalMaximum standardized uptake valuePhase II trialFDG-PET studiesStandardized uptake valueFDG-PET dataFDG-PET imagesEORTC criteriaHypermetabolic uptakeRECIST 1.0II trial