2024
Outcomes with trastuzumab deruxtecan (T-DXd) by HER2 status and line of treatment in a large real-world database of patients with metastatic breast cancer.
Tarantino P, Lee D, Foldi J, Soulos P, Gross C, Grinda T, Winer E, Lin N, Krop I, Tolaney S, Lustberg M, Sammons S. Outcomes with trastuzumab deruxtecan (T-DXd) by HER2 status and line of treatment in a large real-world database of patients with metastatic breast cancer. Journal Of Clinical Oncology 2024, 42: 1077-1077. DOI: 10.1200/jco.2024.42.16_suppl.1077.Peer-Reviewed Original ResearchReal-world progression-free survivalLines of therapyMetastatic breast cancerMedian real-world progression-free survivalT-DXdHER2+Overall survivalHER2-lowHER2- patientsBreast cancerHER2- metastatic breast cancerTreat metastatic breast cancerProgression-free survivalKaplan-Meier methodLines of treatmentDatabase of patientsRetrospective observational studyClinical trial settingHER2 casesIHC 0Trastuzumab deruxtecanHR statusHER2 statusTriple-negativeMedian age
2023
Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases
Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases. JAMA Oncology 2023, 9: 197-205. PMID: 36454580, PMCID: PMC9716438, DOI: 10.1001/jamaoncol.2022.5610.Peer-Reviewed Original ResearchConceptsErbB2-positive metastatic breast cancerMetastatic breast cancerPlacebo-combination groupPositive metastatic breast cancerNew brain lesionsBrain metastasesOverall survivalSubgroup analysisBrain lesionsBreast cancerIntracranial progression-free survivalPlacebo-controlled clinical trialIntracranial objective response rateStable brain metastasesMedian overall survivalObjective response rateProgression-free survivalExploratory subgroup analysisGreater clinical benefitCNS-PFSHER2CLIMB trialIntracranial outcomesFirst progressionMedian ageClinical benefit
2021
Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial)
Ruddy KJ, Zheng Y, Tayob N, Hu J, Dang CT, Yardley DA, Isakoff SJ, Valero VV, Faggen MG, Mulvey TM, Bose R, Sella T, Weckstein DJ, Wolff AC, Reeder-Hayes KE, Rugo HS, Ramaswamy B, Zuckerman DS, Hart LL, Gadi VK, Constantine M, Cheng KL, Briccetti FM, Schneider BP, Merrill Garrett A, Kelly Marcom P, Albain KS, DeFusco PA, Tung NM, Ardman BM, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu MC, Rosenberg S, DeMeo MK, Burstein HJ, Winer EP, Krop IE, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial). Breast Cancer Research And Treatment 2021, 189: 103-110. PMID: 34120223, DOI: 10.1007/s10549-021-06267-8.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaEarly-stage breast cancerRisk of infertilityAdo-trastuzumab emtansineT-DM1Gonadotropin-releasing hormone agonistAdjuvant T-DM1T-DM1 3.6Amenorrhea ratesPermanent menopauseStandard HER2Chemotherapy regimensPrimary endpointProtocol therapyMedian ageOvarian toxicityPremature menopauseHormone agonistBreast cancerMenstrual dataMonthsAmenorrheaEmtansineMenopauseTrastuzumabSurvival in male breast cancer (MaBC) over the past three decades.
Leone J, Freedman R, Leone J, Hassett M, Tolaney S, Vallejo C, Leone B, Winer E, Lin N. Survival in male breast cancer (MaBC) over the past three decades. Journal Of Clinical Oncology 2021, 39: 569-569. DOI: 10.1200/jco.2021.39.15_suppl.569.Peer-Reviewed Original ResearchBreast cancer-specific survivalOverall survivalBreast cancerCox modelWorse breast cancer-specific survivalHormone receptor-negative statusGrade 3 diseaseCancer-specific survivalEnd Results registryReceptor-negative statusYear of diagnosisMale breast cancerMultivariate Cox modelDecade of diagnosisPeriod of diagnosisBreast cancer mortalityProportional hazards regressionLog-rank testCause of deathPatient characteristicsMedian ageHazards regressionCancer mortalityKaplan-MeierBlack raceImpact of Cancer History on Outcomes Among Hospitalized Patients with COVID-19
Klein IA, Rosenberg SM, Reynolds KL, Zubiri L, Rosovsky R, Piper-Vallillo A, Gao X, Boland G, Bardia A, Gaither R, Freeman H, Kirkner GJ, Rhee C, Klompas M, Baker MA, Wadleigh M, Winer EP, Kotton CN, Partridge AH. Impact of Cancer History on Outcomes Among Hospitalized Patients with COVID-19. The Oncologist 2021, 26: 685-693. PMID: 33856099, PMCID: PMC8251362, DOI: 10.1002/onco.13794.Peer-Reviewed Original ResearchConceptsHistory of cancerIndependent risk factorDeath/hospiceSevere COVID-19Survivors of cancerHospitalized patientsCancer historyActive cancerRisk factorsCurrent cancer diagnosisCancer diagnosisCOVID-19Laboratory-confirmed COVID-19Intensive care unit admissionCare unit admissionOdds of intubationCancer-directed therapySystemic cancer therapyStandard anticancer therapiesRecent cancer treatmentUnit admissionHospice admissionMedian ageMedian timeMultivariable analysisPhysical Activity, Weight, and Outcomes in Patients Receiving Chemotherapy for Metastatic Breast Cancer (C40502/Alliance)
Ligibel JA, Huebner L, Rugo HS, Burstein HJ, Toppmeyer DL, Anders CK, Ma C, Barry WT, Suman V, Carey LA, Partridge AH, Hudis CA, Winer EP. Physical Activity, Weight, and Outcomes in Patients Receiving Chemotherapy for Metastatic Breast Cancer (C40502/Alliance). JNCI Cancer Spectrum 2021, 5: pkab025-. PMID: 33981951, PMCID: PMC8103727, DOI: 10.1093/jncics/pkab025.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBody HeightBody Mass IndexBody WeightBreast NeoplasmsEpothilonesExerciseFemaleHumansMiddle AgedObesityPaclitaxelProgression-Free SurvivalProportional Hazards ModelsTreatment OutcomeYoung AdultConceptsProgression-free survivalMetastatic breast cancerBody mass indexOverall survivalPhysical activityBreast cancerMass indexMET hoursFirst-line taxane-based chemotherapyHormone receptor-positive cancersBaseline body mass indexFirst-line chemotherapyTaxane-based chemotherapyReceptor-positive cancersRecreational physical activityRates of obesityMetastatic diseaseCox modelingMedian ageOverall mortalityRandomized trialsTask hoursMetabolic equivalentsPatientsCancerTumor subtypes and survival in male breast cancer
Leone J, Freedman RA, Lin NU, Tolaney SM, Vallejo CT, Leone BA, Winer EP, Leone JP. Tumor subtypes and survival in male breast cancer. Breast Cancer Research And Treatment 2021, 188: 695-702. PMID: 33770314, DOI: 10.1007/s10549-021-06182-y.Peer-Reviewed Original ResearchConceptsBreast cancer-specific survivalOverall survivalTumor subtypesBreast cancerHormone receptorsWorse breast cancer-specific survivalMultivariate Cox proportional hazards analysisCox proportional hazards analysisPurposeMale breast cancerTumor subtype distributionCancer-specific survivalProportional hazards analysisInvasive breast cancerMale breast cancerAggressive tumor biologyCox hazard ratiosPopulation-based informationTN diseaseAdvanced diseaseHazard ratioHR-/HER2Inferior survivalMedian agePatient characteristicsPrognostic factorsClinical Efficacy and Molecular Response Correlates of the WEE1 Inhibitor Adavosertib Combined with Cisplatin in Patients with Metastatic Triple-Negative Breast Cancer
Keenan TE, Li T, Vallius T, Guerriero JL, Tayob N, Kochupurakkal B, Davis J, Pastorello R, Tahara RK, Anderson L, Conway J, He MX, Shannon E, Godin RE, Sorger PK, D'Andrea A, Overmoyer B, Winer EP, Mittendorf EA, Van Allen EM, Shapiro GI, Tolaney SM. Clinical Efficacy and Molecular Response Correlates of the WEE1 Inhibitor Adavosertib Combined with Cisplatin in Patients with Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2021, 27: 983-991. PMID: 33257427, PMCID: PMC7887044, DOI: 10.1158/1078-0432.ccr-20-3089.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerObjective response rateTriple-negative breast cancerWEE1 inhibitor adavosertibPrior linesClinical benefitBreast cancerMedian progression-free survivalTreatment-related grade 3One-sided type I errorImmune-infiltrated tumorsPhase II studyProgression-free survivalT cell infiltrationImmune gene expressionPrior chemotherapyStable diseaseProtocol therapyII studyPartial responseAdverse eventsMedian ageClinical efficacyGrade 3Tumor biopsies
2020
Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer
Sella T, Gelber SI, Poorvu PD, Kim HJ, Dominici L, Guzman-Arocho YD, Collins L, Ruddy KJ, Tamimi RM, Peppercorn JM, Schapira L, Borges VF, Come SE, Warner E, Snow C, Jakubowski DM, Russell CA, Winer EP, Rosenberg SM, Partridge AH. Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer. Breast Cancer Research And Treatment 2020, 186: 157-165. PMID: 33150547, DOI: 10.1007/s10549-020-05989-5.Peer-Reviewed Original ResearchConceptsRecurrence Score resultsNeoadjuvant chemotherapyPathological complete responseBreast cancerBreast Cancer StudyYoung womenEstrogen receptor-positive early breast cancerReceptor-positive early breast cancerYoung Women's Breast Cancer StudyHER2-negative breast cancerScore resultsEarly breast cancerLogistic regression modelingAdjuvant chemotherapyNeoadjuvant therapyProspective cohortComplete responseMedian ageMultivariable analysisRecurrence scoreVs. 5Clinical careTumor specimensStage IPatientsEfficacy of neoadjuvant chemotherapy (NAC) in male breast cancer (MaBC) compared with female breast cancer (FBC): A National Cancer Database (NCDB) study.
Leone J, Freedman R, Hassett M, Leone J, Tolaney S, Vallejo C, Leone B, Winer E, Lin N. Efficacy of neoadjuvant chemotherapy (NAC) in male breast cancer (MaBC) compared with female breast cancer (FBC): A National Cancer Database (NCDB) study. Journal Of Clinical Oncology 2020, 38: 587-587. DOI: 10.1200/jco.2020.38.15_suppl.587.Peer-Reviewed Original ResearchFemale breast cancerPathologic complete responseNeoadjuvant chemotherapyOverall survivalClinical responseTumor subtypesBreast cancerWorse OSExact testHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusEfficacy of NACInitiation of NACNational Cancer Database studyComplete clinical responseHormone receptor statusMale breast cancerLog-rank testFisher's exact testHR-/HER2Complete responseMedian ageReceptor statusMedian timeClinical stageAvoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study
Vaz-Luis I, Barroso-Sousa R, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, O'Neil K, Partridge A, Burstein H, Waks AG, Trippa L, Tolaney SM, Hassett M, Winer EP, Lin NU. Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study. Journal Of Clinical Oncology 2020, 38: 2390-2397. PMID: 32330102, PMCID: PMC7367545, DOI: 10.1200/jco.19.02484.Peer-Reviewed Original ResearchConceptsDose-dense paclitaxelPeg-filgrastimFebrile neutropeniaDay 1Adjuvant breast cancer chemotherapyCycle 1 day 1Patient experienced febrile neutropeniaCycles of paclitaxelDose-dense doxorubicinExperienced febrile neutropeniaPrimary end pointSingle-arm studyBreast cancer chemotherapyYears of ageDose delaysDoxorubicin-cyclophosphamidePaclitaxel cyclesPaclitaxel regimenPatients 18Investigator's discretionMedian ageTreatment delayProspective studyPrespecified algorithmBreast cancer
2019
Avoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study.
Barroso-Sousa R, Luis I, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone J, Constantine M, Faggen M, Briccetti F, Block C, Partridge A, Burstein H, Waks A, Trippa L, Tolaney S, Hassett M, Winer E, Lin N. Avoiding peg-filgrastim (Peg-F) prophylaxis during the paclitaxel (T) portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-T regimen: A prospective study. Journal Of Clinical Oncology 2019, 37: 517-517. DOI: 10.1200/jco.2019.37.15_suppl.517.Peer-Reviewed Original ResearchAbsolute neutrophil countFebrile neutropeniaDd ACGrowth factorAdjuvant breast cancer chemotherapyCycle 1 day 1Dose-dense doxorubicinSingle-arm studyBreast cancer chemotherapyPre-specified algorithmT regimenHematologic toxicityProtocol therapySecondary endpointsPrimary endpointDose modificationInvestigator's discretionMedian ageNeutrophil countProspective studyTreatment delayDose reductionCommon reasonRegimenDay 1Randomized phase II study of eribulin mesylate (E) with or without pembrolizumab (P) for hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Tolaney S, Barroso-Sousa R, Keenan T, Trippa L, Hu J, Luis I, Wulf G, Spring L, Sinclair N, Andrews C, Pittenger J, Richardson E, Dillon D, Lin N, Overmoyer B, Partridge A, VanAllen E, Mittendorf E, Winer E, Krop I. Randomized phase II study of eribulin mesylate (E) with or without pembrolizumab (P) for hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2019, 37: 1004-1004. DOI: 10.1200/jco.2019.37.15_suppl.1004.Peer-Reviewed Original ResearchProgression-free survivalObjective response rateNeutrophil-lymphocyte ratioTumor-infiltrating lymphocytesTumor mutation burdenOverall survivalPrior linesMedian progression-free survivalCheckpoint inhibitor monotherapyMedian prior linesKey secondary endpointLines of chemotherapyPD-L1 statusTime of progressionChemotherapy 1Eligible patientsHormonal therapyPrimary endpointProtocol therapySecondary endpointsInhibitor monotherapyArm BMedian ageArm ATherapy 2
2018
Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study
Li D, McCall LM, Hahn OM, Hudis CA, Cohen HJ, Muss HB, Jatoi A, Lafky JM, Ballman KV, Winer EP, Tripathy D, Schneider B, Barry W, Dickler MN, Hurria A. Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Research And Treatment 2018, 171: 325-334. PMID: 29789969, PMCID: PMC6076849, DOI: 10.1007/s10549-018-4828-5.Peer-Reviewed Original ResearchConceptsHormone receptor-positive advanced breast cancerAdvanced breast cancerIncidence of gradeAdverse eventsBreast cancerPhysical functionProgression-free survival benefitMultivariable logistic regression modelAddition of bevacizumabPhase III trialsPhysical function measuresAdverse event dataFunctional Assessment MeasureIncidence of toxicityFlight of stairsLogistic regression modelsHemorrhagic eventsIII trialsSurvival benefitMedian ageThrombosis eventsRisk factorsUnivariate analysisAssessment measuresBevacizumabCharacterization of male breast cancer: results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program
Cardoso F, Bartlett J, Slaets L, van Deurzen C, van Leeuwen-Stok E, Porter P, Linderholm B, Hedenfalk I, Schröder C, Martens J, Bayani J, van Asperen C, Murray M, Hudis C, Middleton L, Vermeij J, Punie K, Fraser J, Nowaczyk M, Rubio I, Aebi S, Kelly C, Ruddy K, Winer E, Nilsson C, Dal Lago L, Korde L, Benstead K, Bogler O, Goulioti T, Peric A, Litière S, Aalders K, Poncet C, Tryfonidis K, Giordano S. Characterization of male breast cancer: results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program. Annals Of Oncology 2018, 29: 405-417. PMID: 29092024, PMCID: PMC5834077, DOI: 10.1093/annonc/mdx651.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalMale breast cancerAdjuvant endocrine therapyBreast cancerEndocrine therapySentinel lymph node biopsyLymph node biopsyBreast cancer programFemale breast cancerDuctal invasive carcinomaBC mortalityIHC subtypesIHC surrogatesAdjuvant radiotherapyM1 patientsMetastatic diseaseMedian ageCentral pathologyM0 tumorsM0 casesProgesterone receptorCancer programsInvasive carcinomaKi67 expressionAndrogen receptor
2017
Evaluating the addition of bevacizumab (Bev) to endocrine therapy as first-line treatment for hormone-receptor positive (HR+)/HER2-negative advanced breast cancer (ABC): Pooled-analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials.
Martin M, Loibl S, Hyslop T, de la Haba-Rodriguez J, Aktas B, Cirrincione C, Carrasco E, Mehta K, Barry W, Morales S, Carey L, Garcia Saenz J, Partridge A, Martinez N, Hahn O, Winer E, Guerrero A, Hudis C, Casas M, Dickler M. Evaluating the addition of bevacizumab (Bev) to endocrine therapy as first-line treatment for hormone-receptor positive (HR+)/HER2-negative advanced breast cancer (ABC): Pooled-analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials. Journal Of Clinical Oncology 2017, 35: 1012-1012. DOI: 10.1200/jco.2017.35.15_suppl.1012.Peer-Reviewed Original ResearchProgression-free survivalAdvanced breast cancerRandomized trialsMedian progression-free survivalNegative advanced breast cancerBreast Cancer Research FoundationAddition of BevMultivariable Cox modelAddition of bevacizumabFirst-line treatmentCancer Research FoundationCardiovascular eventsPgR statusSecondary endpointsLiver eventsRecurrent diseaseMedian ageMultivariable analysisTreatment armsPatient populationBreast cancerGrade 3Prolonged benefitCox modelStudy-level differencesA mouse-human phase I co-clinical trial of taselisib in combination with TDM1 in advanced HER2-positive breast cancer (MBC).
Metzger Filho O, Goel S, Barry W, Hamilton E, Tolaney S, Yardley D, Rees R, Demeo M, Mills C, Hafner M, Winer E, Zhao J, Krop I. A mouse-human phase I co-clinical trial of taselisib in combination with TDM1 in advanced HER2-positive breast cancer (MBC). Journal Of Clinical Oncology 2017, 35: 1030-1030. DOI: 10.1200/jco.2017.35.15_suppl.1030.Peer-Reviewed Original ResearchPhase Ib studyT-DM1Co-clinical trialsIb studyAdvanced HER2-positive breast cancerT-DM1-resistant cellsHER2-positive breast cancerPR/CRAcceptable safety profileAnti-HER2 therapyPI3K blockadePre-clinical experimentsConfirmed responsesMedian PFSPJP prophylaxisMedian durationMedian agePIK3CA H1047RPIK3CA statusSafety profilePneumocystis pneumoniaHER2 expressionClinical resultsMammary carcinomaBreast cancer
2016
The Metastatic Breast Cancer Project: A national direct-to-patient initiative to accelerate genomics research.
Wagle N, Painter C, Krevalin M, Oh C, Anderka K, Larkin K, Lennon N, Dillon D, Frank E, Winer E, Lander E, Golub T. The Metastatic Breast Cancer Project: A national direct-to-patient initiative to accelerate genomics research. Journal Of Clinical Oncology 2016, 34: lba1519-lba1519. DOI: 10.1200/jco.2016.34.18_suppl.lba1519.Peer-Reviewed Original ResearchMetastatic breast cancerBreast Cancer ProjectMedical recordsMedian timeBreast cancerDe novo metastatic breast cancerMedical providersCancer ProjectNovo metastatic breast cancerMedian ageInitial diagnosisTumor biopsiesMost tumorsSaliva kitsClinical informationNationwide studyExtraordinary responsePatient approachCommunity settingsTumorsPatient initiativeSaliva samplesTherapyGermline DNACancerRandomized trial of a physical activity intervention in women with metastatic breast cancer
Ligibel JA, Giobbie-Hurder A, Shockro L, Campbell N, Partridge AH, Tolaney SM, Lin NU, Winer EP. Randomized trial of a physical activity intervention in women with metastatic breast cancer. Cancer 2016, 122: 1169-1177. PMID: 26872302, DOI: 10.1002/cncr.29899.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBreast NeoplasmsChemotherapy, AdjuvantChi-Square DistributionCombined Modality TherapyDisease-Free SurvivalExercise TherapyFemaleFollow-Up StudiesHumansMastectomy, SegmentalMiddle AgedNeoplasm InvasivenessNeoplasm StagingPhysical FitnessQuality of LifeRadiotherapy, AdjuvantReference ValuesSurvival AnalysisTreatment OutcomeUnited StatesConceptsMetastatic breast cancerEarly-stage breast cancerExercise interventionBreast cancerPhysical functioningLife Questionnaire-Core 30 questionnaireModerate-intensity aerobic exercisePhysical Activity Recall interviewModerate-intensity exercise interventionAdvanced breast cancerPhysical activity interventionsTime of enrollmentWait-list control groupQuality of lifeMetastatic diseaseCancer QualityMedian ageIntervention armMedian timeActivity interventionsAerobic exerciseWeekly exerciseTreadmill testFunctional capacityNonsignificant increase
2015
SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast Cancer
Gonzalez-Angulo AM, Krop I, Akcakanat A, Chen H, Liu S, Li Y, Culotta KS, Tarco E, Piha-Paul S, Moulder-Thompson S, Velez-Bravo V, Sahin AA, Doyle LA, Do KA, Winer EP, Mills GB, Kurzrock R, Meric-Bernstam F. SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast Cancer. Journal Of The National Cancer Institute 2015, 107: dju493. PMID: 25688104, PMCID: PMC4342675, DOI: 10.1093/jnci/dju493.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDrug Administration ScheduleDrug EruptionsFatigueFemaleHeterocyclic Compounds, 3-RingHumansHyperglycemiaMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNeutropeniaPaclitaxelSeverity of Illness IndexTreatment OutcomeConceptsDose escalationDay 1Day 2Higher adverse eventsPhase Ib studyWeeks of therapyAdvanced solid tumorsCTCAE grade 3Metastatic breast cancerPrevious phase IPreliminary antitumor activityDose expansionStable diseaseObjective responseUnacceptable toxicityAdverse eventsMedian ageWeekly dosesClinical benefitPharmacodynamic markersSystemic exposureExcessive toxicityTumor responseGrade 3Median number