2023
Comprehensive genomic characterization of HER2-low and HER2-0 breast cancer
Tarantino P, Gupta H, Hughes M, Files J, Strauss S, Kirkner G, Feeney A, Li Y, Garrido-Castro A, Barroso-Sousa R, Bychkovsky B, DiLascio S, Sholl L, MacConaill L, Lindeman N, Johnson B, Meyerson M, Jeselsohn R, Qiu X, Li R, Long H, Winer E, Dillon D, Curigliano G, Cherniack A, Tolaney S, Lin N. Comprehensive genomic characterization of HER2-low and HER2-0 breast cancer. Nature Communications 2023, 14: 7496. PMID: 37980405, PMCID: PMC10657399, DOI: 10.1038/s41467-023-43324-w.Peer-Reviewed Original ResearchConceptsHER2-low tumorsBreast cancerHER2-negative metastatic breast cancerMetastatic breast cancerTumor mutational burdenHigh rateComprehensive genomic characterizationHER2 0Mutational burdenBreast tumorsTumorsHER2Genomic alterationsNext-generation sequencingSignificant differencesGenomic findingsCancerGenomic landscapeMolecular underpinningsHemideletionGenomic characterizationHigher numberPatientsCopy counts
2021
Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer
Lynce F, Williams JT, Regan MM, Bunnell CA, Freedman RA, Tolaney SM, Chen WY, Mayer EL, Partridge AH, Winer EP, Overmoyer B. Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer. Cancer Chemotherapy And Pharmacology 2021, 87: 673-679. PMID: 33585999, DOI: 10.1007/s00280-021-04245-x.Peer-Reviewed Original ResearchConceptsHER2-negative metastatic breast cancerMetastatic breast cancerBreast cancerWeekly paclitaxelAdvanced diseaseHormone receptor-positive diseaseTriple-negative breast cancerGrade 4/5 toxicitiesMost frequent toxicitiesPhase 2 doseWeekly paclitaxel 80Receptor-positive diseaseDose-escalation designJAK1/2 inhibitor ruxolitinibCombination of ruxolitinibBreast cancer cellsOral ruxolitinibPaclitaxel 80PurposePreclinical studiesChemotherapy regimensFrequent toxicitiesProtocol therapyMethodsEligible patientsThirteen patientsVisceral disease
2019
A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma
Mayer EL, DeMichele A, Rugo HS, Miller K, Waks AG, Come SE, Mulvey T, Jeselsohn R, Overmoyer B, Guo H, Barry WT, Bartlett C, Koehler M, Winer EP, Burstein HJ. A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma. Annals Of Oncology 2019, 30: 1514-1520. PMID: 31250880, DOI: 10.1093/annonc/mdz198.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFeasibility StudiesFemaleFulvestrantHumansMiddle AgedNeoplasm InvasivenessNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneConceptsEarly breast cancerEndocrine therapyAdjuvant palbociclibBreast cancerHormone receptor-positive/HER2-negative metastatic breast cancerHER2-negative metastatic breast cancerPhase II feasibility studyProlong progression-free survivalRandomized phase III trialAdjuvant endocrine therapyPrimary end pointStage III diseasePhase II trialPhase III trialsProgression-free survivalMetastatic breast cancerYears of therapyStart of treatmentInvasive breast carcinomaEligible patientsFebrile neutropeniaPrior chemotherapyWeeks on/1II trialCumulative incidenceNimbus: A phase II study of nivolumab plus ipilimumab in metastatic hypermutated HER2-negative breast cancer.
Barroso-Sousa R, Trippa L, Lange P, Andrews C, McArthur H, Haley B, Rugo H, Emens L, Winer E, Mittendorf E, Tolaney S. Nimbus: A phase II study of nivolumab plus ipilimumab in metastatic hypermutated HER2-negative breast cancer. Journal Of Clinical Oncology 2019, 37: tps1115-tps1115. DOI: 10.1200/jco.2019.37.15_suppl.tps1115.Peer-Reviewed Original ResearchMetastatic breast cancerTumor mutational burdenHER2-negative breast cancerBreast cancerResponse rateObjective responseTrue response rateMetastatic HER2-negative breast cancerHER2-negative metastatic breast cancerFurther studiesCombination of nivolumabEfficacy of nivolumabPhase 2 studyPhase II studyProgression-free survivalOverall response rateMut/MbMutations/megabaseCancer gene panelRECIST 1.1II studyOverall survivalPrior linesPeripheral bloodDisease progression
2011
PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer.
Olson E, Flores L, Najita J, Curley C, Jeong J, Murray K, Savoie J, Winer E, Krop I. PD05-07: Prospective Validation and Characterization of HER2 Positive Circulating Tumor Cells in Patients with HER2 Negative Metastatic Breast Cancer. Cancer Research 2011, 71: pd05-07-pd05-07. DOI: 10.1158/0008-5472.sabcs11-pd05-07.Peer-Reviewed Original ResearchHER2-positive CTCsMetastatic breast cancerHER2-negative metastatic breast cancerNegative metastatic breast cancerHER2-negative CTCsER-positive diseasePositive CTCsBreast cancerDetectable CTCsLobular histologyPositive diseaseNegative CTCsHER2 amplificationProspective validationHER2-Positive Circulating Tumor CellsHER2-negative breast cancerCEP17 ratioTumor cellsInitial screeningMajority of ptsNegative breast cancerHER2/CEP17 ratioCirculating Tumor CellsDuctal histologyBaseline characteristics
2007
Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions
Lin NU, Parker LM, Come SE, Burstein HJ, Haldoupis M, Ryabin N, Gelman R, Winer EP, Shulman LN. Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions. Investigational New Drugs 2007, 25: 369-375. PMID: 17345004, DOI: 10.1007/s10637-007-9034-y.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerHypersensitivity reactionsEfficacy of CTBreast cancerPrior linesPatient populationGrade 3HER2-negative metastatic breast cancerSmall studyHER2-negative breast cancerTrue drug allergyPhase II studySecond-line chemotherapyPercent of womenNovel conjugatesAdjuvant settingConjugated paclitaxelEighteen womenIntravenous CTMetastatic treatmentPrior chemotherapyRoutine premedicationDrug allergyII studyObjective response