2024
Helping ourselves, helping others: the Young Women’s Breast Cancer Study (YWS) – a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger
Rosenberg S, Zheng Y, Ruddy K, Poorvu P, Snow C, Kirkner G, Meyer M, Tamimi R, Schapira L, Peppercorn J, Come S, Borges V, Warner E, Gelber S, Collins L, Winer E, Partridge A. Helping ourselves, helping others: the Young Women’s Breast Cancer Study (YWS) – a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger. BMJ Open 2024, 14: e081157. PMID: 38951008, PMCID: PMC11218027, DOI: 10.1136/bmjopen-2023-081157.Peer-Reviewed Original ResearchConceptsYoung Women's Breast Cancer StudyMultisite prospective cohort studyBreast Cancer StudyProspective cohort studyStage 0-IV breast cancerBreast cancerCohort studyOlder womenDied of breast cancerFear of recurrencePatient-reported outcome dataYoung womenCancer studiesClinical data abstractionPost-traumatic stressQuality of lifeImprove careFollow-upPsychosocial outcomesYoung survivorsCommunity sitesBiospecimen collectionUnderstudied populationData abstractionOutcome dataEndocrine-Sensitive Disease Rate in Postmenopausal Patients With Estrogen Receptor–Rich/ERBB2-Negative Breast Cancer Receiving Neoadjuvant Anastrozole, Fulvestrant, or Their Combination
X. C, Suman V, Sanati S, Vij K, Anurag M, Leitch A, Unzeitig G, Hoog J, Fernandez-Martinez A, Fan C, Gibbs R, Watson M, Dockter T, Hahn O, Guenther J, Caudle A, Crouch E, Tiersten A, Mita M, Razaq W, Hieken T, Wang Y, Rimawi M, Weiss A, Winer E, Hunt K, Perou C, Ellis M, Partridge A, Carey L. Endocrine-Sensitive Disease Rate in Postmenopausal Patients With Estrogen Receptor–Rich/ERBB2-Negative Breast Cancer Receiving Neoadjuvant Anastrozole, Fulvestrant, or Their Combination. JAMA Oncology 2024, 10: 362-371. PMID: 38236590, PMCID: PMC10797521, DOI: 10.1001/jamaoncol.2023.6038.Peer-Reviewed Original ResearchConceptsNeoadjuvant endocrine therapyBreast cancerWeek 4Neoadjuvant chemotherapyPostmenopausal womenPAM50 subtypesNonluminal tumorsClinical stage II to IIIRate of pathological complete responseClinical trialsHER2)-negative breast cancerPhase 3 randomized clinical trialLuminal B tumorsPathological complete responseLuminal A tumorsEarly-stage diseaseRandomized clinical trialsStage II to IIIAnastrozole armNeoadjuvant anastrozoleTumor Ki67Postmenopausal patientsB tumorsComplete responseA tumors
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 countsImmunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials
Rediti M, Fernandez-Martinez A, Venet D, Rothé F, Hoadley K, Parker J, Singh B, Campbell J, Ballman K, Hillman D, Winer E, El-Abed S, Piccart M, Di Cosimo S, Symmans W, Krop I, Salgado R, Loi S, Pusztai L, Perou C, Carey L, Sotiriou C. Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials. Nature Communications 2023, 14: 7053. PMID: 37923752, PMCID: PMC10624889, DOI: 10.1038/s41467-023-42635-2.Peer-Reviewed Original ResearchConceptsEvent-free survivalHER2-positive breast cancerPathological complete responseCALGB 40601Breast cancerBreast pathological complete responseStromal tumor-infiltrating lymphocytesHormone receptor statusPhase III trialsClinical nodal statusIndependent prognostic factorTumor-infiltrating lymphocytesIdentification of patientsBreast cancer prognosisT cell receptorNeoadjuvant paclitaxelNeoadjuvant therapyIII trialsNodal statusComplete responsePrognostic factorsPrognostic scoreReceptor statusClinicopathological featuresResidual diseaseCorrelation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial)
Hennessy M, Leal J, Huang C, Solnes L, Denbow R, Abramson V, Carey L, Liu M, Rimawi M, Specht J, Storniolo A, Valero V, Vaklavas C, Winer E, Krop I, Wolff A, Cimino-Mathews A, Wahl R, Stearns V, Connolly R. Correlation of SUV on Early Interim PET with Recurrence-Free Survival and Overall Survival in Primary Operable HER2-Positive Breast Cancer (the TBCRC026 Trial). Journal Of Nuclear Medicine 2023, 64: jnumed.123.265853. PMID: 37652539, DOI: 10.2967/jnumed.123.265853.Peer-Reviewed Original ResearchConceptsF-FDG PET/CTHER2-positive breast cancerRecurrence-free survivalPET/CTPathologic complete responseOverall survivalBreast cancerOperable HER2-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Growth factor receptor 2Kaplan-Meier methodStatistical significanceLean body massFactor receptor 2Imaging-based biomarkersCorrelation of SUVHER2 therapyNeoadjuvant trastuzumabNeoadjuvant therapyAdjuvant therapyComplete responsePhysician's discretionOS outcomesCox regressionCirculating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆
Parsons H, Blewett T, Chu X, Sridhar S, Santos K, Xiong K, Abramson V, Patel A, Cheng J, Brufsky A, Rhoades J, Force J, Liu R, Traina T, Carey L, Rimawi M, Miller K, Stearns V, Specht J, Falkson C, Burstein H, Wolff A, Winer E, Tayob N, Krop I, Makrigiorgos G, Golub T, Mayer E, Adalsteinsson V. Circulating tumor DNA association with residual cancer burden after neoadjuvant chemotherapy in triple-negative breast cancer in TBCRC 030 ☆. Annals Of Oncology 2023, 34: 899-906. PMID: 37597579, PMCID: PMC10898256, DOI: 10.1016/j.annonc.2023.08.004.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerResidual cancer burdenNeoadjuvant chemotherapyCancer burdenBreast cancerWeek 3Additional neoadjuvant chemotherapyPlasma samplesCase-control analysisCtDNA clearanceCtDNA positivityNeoadjuvant paclitaxelDisease recurrenceProspective studyWeek 12RCB 0CtDNA assaysPatientsSufficient tissueChemotherapyTumor fractionTumor DNARCB-3RespondersAdditional studiesImpact of BMI in Patients With Early Hormone Receptor–Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial
Pfeiler G, Hlauschek D, Mayer E, Deutschmann C, Kacerovsky-Strobl S, Martin M, Meisel J, Zdenkowski N, Loibl S, Balic M, Park H, Prat A, Isaacs C, Bajetta E, Balko J, Bellet-Ezquerra M, Bliss J, Burstein H, Cardoso F, Fohler H, Foukakis T, Gelmon K, Goetz M, Haddad T, Iwata H, Jassem J, Lee S, Linderholm B, Los M, Mamounas E, Miller K, Morris P, Munzone E, Gal-Yam E, Ring A, Shepherd L, Singer C, Thomssen C, Tseng L, Valagussa P, Winer E, Wolff A, Zoppoli G, Machacek-Link J, Schurmans C, Huang X, Gauthier E, Fesl C, Dueck A, DeMichele A, Gnant M, Cameron D, El-Abed S, Rugo H, Steger G, Traina T, Werutsky G, Wolmark N. Impact of BMI in Patients With Early Hormone Receptor–Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial. Journal Of Clinical Oncology 2023, 41: 5118-5130. PMID: 37556775, DOI: 10.1200/jco.23.00126.Peer-Reviewed Original ResearchConceptsImpact of BMIPALLAS trialBMI categoriesHigher BMIEarly hormone receptor-positive breast cancerHormone receptor-positive breast cancerReceptor-positive breast cancerAddition of palbociclibEfficacy of palbociclibEarly treatment discontinuationRelative dose intensityTreatment discontinuation ratesDisease-free survivalSide effect profileMultivariable logistic regressionBreast cancer riskSignificant decreaseNeutropenia ratesPalbociclib armEndocrine therapyTreatment discontinuationDiscontinuation ratesDose intensityEarly discontinuationNormal weightEstimating mortality in women with triple-negative breast cancer: The ‘ESTIMATE triple-negative’ tool
Leone J, Graham N, Leone J, Tolaney S, Leone B, Freedman R, Hassett M, Vallejo C, Winer E, Lin N, Tayob N. Estimating mortality in women with triple-negative breast cancer: The ‘ESTIMATE triple-negative’ tool. European Journal Of Cancer 2023, 189: 112930. PMID: 37356327, DOI: 10.1016/j.ejca.2023.05.018.Peer-Reviewed Original ResearchMeSH KeywordsBreastBreast NeoplasmsFemaleHumansNeoplasm StagingPrognosisSEER ProgramTriple Negative Breast NeoplasmsConceptsBreast cancer-specific mortalityTriple-negative breast cancerRisk of BCSMTumor characteristicsBreast cancerCumulative riskNon-metastatic triple-negative breast cancerMost tumor characteristicsCancer-specific mortalityRisk of deathPopulation-based riskHigh-grade triple-negative breast cancerCause mortalityMost patientsPathologic variablesInitial diagnosisHigh riskNew diagnosisPatientsMortalityDiagnosisYear 0RiskCancerWomenAssessment of the HER2DX Assay in Patients With ERBB2-Positive Breast Cancer Treated With Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab
Waks A, Ogayo E, Paré L, Marín-Aguilera M, Brasó-Maristany F, Galván P, Castillo O, Martínez-Sáez O, Vivancos A, Villagrasa P, Villacampa G, Tarantino P, Desai N, Guerriero J, Metzger O, Tung N, Krop I, Parker J, Perou C, Prat A, Winer E, Tolaney S, Mittendorf E. Assessment of the HER2DX Assay in Patients With ERBB2-Positive Breast Cancer Treated With Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab. JAMA Oncology 2023, 9: 835-840. PMID: 37103927, PMCID: PMC10141272, DOI: 10.1001/jamaoncol.2023.0181.Peer-Reviewed Original ResearchConceptsPathologic complete responseNeoadjuvant therapyPCR scoresNeoadjuvant paclitaxelBreast cancerPrognostic studiesRisk scoreLikelihood of pCRPretreatment tumor biopsy samplesErbB2-positive breast cancerBaseline tumor samplesLimited clinical featuresFavorable survival outcomesHormone receptor statusPositive breast cancerPrognostic risk scoreTumor biopsy samplesPaclitaxel weeklyComplete responsePCR rateReceptor statusClinical featuresMean ageSurvival outcomesRecurrence eventsImpact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial.
Weiss A, Li T, Desai N, Tung N, Poorvu P, Partridge A, Nakhlis F, Dominici L, Sinclair N, Spring L, Faggen M, Constantine M, Krop I, DeMeo M, Wrabel E, Alberti J, Chikarmane S, Tayob N, King T, Tolaney S, Winer E, Mittendorf E, Waks A. Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial. Journal Of The American College Of Surgeons 2023, 237: 247-256. PMID: 37194964, DOI: 10.1097/xcs.0000000000000761.Peer-Reviewed Original ResearchConceptsBreast conservation therapyTrastuzumab/pertuzumabBreast cancerTumor downsizingSystemic therapyBCT ratesSingle-arm prospective clinical trialBreast pathologic complete responseSingle-arm prospective trialBreast cancer warrants further investigationBCT-eligible patientsBreast size ratioCancer warrants further investigationEarly-stage HER2Neoadjuvant systemic therapyPathologic complete responseProspective clinical trialsWarrants further investigationBCT eligibilityMulticentric tumorsNeoadjuvant regimensProspective trialComplete responseLocal therapyConservation therapyNodal positivity and systemic therapy among patients with clinical T1–T2N0 human epidermal growth factor receptor‐positive breast cancer: Results from two international cohorts
Weiss A, Martínez‐Sáez O, Waks A, Laws A, McGrath M, Tarantino P, Portnow L, Winer E, Rey M, Tapia M, Prat A, Partridge A, Tolaney S, Cejalvo J, Mittendorf E, King T. Nodal positivity and systemic therapy among patients with clinical T1–T2N0 human epidermal growth factor receptor‐positive breast cancer: Results from two international cohorts. Cancer 2023, 129: 1836-1845. PMID: 36951169, DOI: 10.1002/cncr.34750.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerNeoadjuvant chemotherapyUpfront surgeryNodal positivityBreast cancerTumor sizeALND ratesCT1c tumorsTreatment strategiesSmall human epidermal growth factor receptor 2Lymph node dissection ratesReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Clinical T1-T2Lymph node positiveHER2-positive patientsGrowth factor receptor 2Optimal treatment strategyFactor receptor 2Nodal statusSystemic therapyNode positiveAxillary imagingPositive tumorsAdjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial
Tolaney S, Tarantino P, Graham N, Tayob N, Parè L, Villacampa G, Dang C, Yardley D, Moy B, Marcom P, Albain K, Rugo H, Ellis M, Shapira I, Wolff A, Carey L, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo J, Weiss J, Wagle N, Partridge A, Waks A, Hudis C, Krop I, Burstein H, Prat A, Winer E. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. The Lancet Oncology 2023, 24: 273-285. PMID: 36858723, DOI: 10.1016/s1470-2045(23)00051-7.Peer-Reviewed Original ResearchMeSH KeywordsBreastBreast NeoplasmsFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalPaclitaxelTrastuzumabConceptsHER2-positive breast cancerInvasive disease-free survivalDisease-free survivalRecurrence-free intervalAdjuvant paclitaxelBreast cancerEastern Cooperative Oncology Group performance statusInvasive disease-free survival eventsDisease-free survival eventsHormone receptor-positive diseaseNew contralateral breast cancerBreast cancer-specific survivalProtocol-defined treatmentCancer-specific survivalReceptor-positive diseasePhase 2 studyContralateral breast cancerLong-term outcomesAPT trialCause deathEligible patientsIntravenous paclitaxelTrastuzumab weeklyDistant recurrenceIpsilateral recurrenceTucatinib 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
2022
Survival in male breast cancer over the past 3 decades
Leone J, Freedman R, Leone J, Tolaney S, Vallejo C, Leone B, Winer E, Lin N, Hassett M. Survival in male breast cancer over the past 3 decades. Journal Of The National Cancer Institute 2022, 115: 421-428. PMID: 36583555, PMCID: PMC10086618, DOI: 10.1093/jnci/djac241.Peer-Reviewed Original ResearchMeSH KeywordsBreastBreast NeoplasmsBreast Neoplasms, MaleFemaleHumansMaleProportional Hazards ModelsRegistriesConceptsBreast cancer-specific survivalMale breast cancerOverall survivalBreast cancerMultivariable Cox regressionCancer-specific survivalEnd Results registryYear of diagnosisBreast cancer mortalityStage of diseaseLog-rank testCox regressionCancer mortalityKaplan-MeierIndependent associationCox modelSignificant improvementSignificant associationCancerLife expectancyDiagnosisSurvivalSignificant differencesPatientsMenAdjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials
Pagani O, Walley B, Fleming G, Colleoni M, Láng I, Gomez H, Tondini C, Burstein H, Goetz M, Ciruelos E, Stearns V, Bonnefoi H, Martino S, Geyer C, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer E, Ruepp B, Loi S, Coates A, Gelber R, Goldhirsch A, Regan M, Francis P, Group F. Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. Journal Of Clinical Oncology 2022, 41: 1376-1382. PMID: 36521078, PMCID: PMC10419413, DOI: 10.1200/jco.22.01064.Peer-Reviewed Original ResearchConceptsDistant recurrence-free intervalOvarian function suppressionDisease-free survivalPrimary end pointOverall survivalAdjuvant exemestaneEnd pointBreast cancerReceptor-positive early breast cancerHuman epidermal growth factor receptorClinical trial updateYears of exemestaneOverall survival benefitHigh-risk patientsPremenopausal breast cancerRecurrence-free intervalEarly breast cancerGrade 3 tumorsRisk of recurrenceEpidermal growth factor receptorGrowth factor receptorSOFT trialTreat populationOvarian suppressionPremenopausal womenAdjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT
Francis P, Fleming G, Láng I, Ciruelos E, Bonnefoi H, Bellet M, Bernardo A, Climent M, Martino S, Bermejo B, Burstein H, Davidson N, Geyer C, Walley B, Ingle J, Coleman R, Müller B, Le Du F, Loibl S, Winer E, Ruepp B, Loi S, Colleoni M, Coates A, Gelber R, Goldhirsch A, Regan M, Group F. Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. Journal Of Clinical Oncology 2022, 41: 1370-1375. PMID: 36493334, PMCID: PMC10419521, DOI: 10.1200/jco.22.01065.Peer-Reviewed Original ResearchConceptsOvarian function suppressionDisease-free survivalAdjuvant endocrine therapyPrimary end pointOverall survivalAdjuvant tamoxifenEndocrine therapyEnd pointBreast cancerHuman epidermal growth factor receptor-2-negative tumoursTamoxifen plus ovarian function suppressionHormone receptor-positive breast cancerReceptor-positive breast cancerClinical trial updateOvarian Function TrialPremenopausal breast cancerHigher baseline riskPrior chemotherapyPremenopausal womenTrial updateClinical trialsBaseline riskMultiple end pointsTamoxifenExemestaneThe oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer
Bardia A, Mayer I, Winer E, Linden H, Ma C, Parker B, Bellet M, Arteaga C, Cheeti S, Gates M, Chang C, Fredrickson J, Spoerke J, Moore H, Giltnane J, Friedman L, Chow Maneval E, Chan I, Jhaveri K. The oral selective estrogen receptor degrader GDC-0810 (ARN-810) in postmenopausal women with hormone receptor-positive HER2-negative (HR + /HER2 −) advanced/metastatic breast cancer. Breast Cancer Research And Treatment 2022, 197: 319-331. PMID: 36401732, PMCID: PMC9823088, DOI: 10.1007/s10549-022-06797-9.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerSelective estrogen receptor degraderDose escalationESR1 mutationsPostmenopausal womenBreast cancerEstrogen receptorCombination treatmentNon-complete response/non-progressive diseaseAdvanced/Metastatic Breast CancerOral selective estrogen receptor degraderPreliminary anti-tumor activityESR1 mutation statusPhase 2 dosePlasma ctDNA samplesCommon adverse eventsNon-progressive diseaseDose-limiting toxicityHormone-releasing hormoneSelective estrogen receptorAnti-tumor activityStable diseaseAdverse eventsPartial responseProgressive diseaseSurrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
Conforti F, Pala L, Bagnardi V, De Pas T, Colleoni M, Buyse M, Hortobagyi G, Gianni L, Winer E, Loibl S, Cortes J, Piccart M, Wolff AC, Viale G, Gelber RD. Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer. JAMA Oncology 2022, 8: 1668-1675. PMID: 36201176, DOI: 10.1001/jamaoncol.2022.3755.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersBreast NeoplasmsDisease-Free SurvivalDrug ApprovalFemaleHumansNeoadjuvant TherapyConceptsSurrogate end pointsPathologic complete responseEarly breast cancerBreast cancerEnd pointComplete responseClinical outcomesClinical benefitEvent-free survival dataLong-term patient outcomesReliable surrogate end pointsTrial levelPatient clinical benefitPatients' clinical outcomesAccelerated approval processNeoadjuvant RCTNeoadjuvant therapyPatient survivalClinical trialsDrug regulatory policyEffective therapyPathological responsePatient outcomesPatient levelDrug effectsPhase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer
Waks AG, Keenan TE, Li T, Tayob N, Wulf GM, Richardson ET, Attaya V, Anderson L, Mittendorf EA, Overmoyer B, Winer EP, Krop IE, Agudo J, Van Allen EM, Tolaney SM. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. Journal For ImmunoTherapy Of Cancer 2022, 10: e005119. PMID: 36252998, PMCID: PMC9577940, DOI: 10.1136/jitc-2022-005119.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalMetastatic breast cancerAdverse eventsBreast cancerT-DM1Immune biomarkersTrastuzumab emtansineHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerGrade 3 adverse eventsMedian progression-free survivalTreatment-related adverse eventsHuman epidermal growth factor receptor 2Cell death ligand 1HER2-positive breast cancerEpidermal growth factor receptor 2Dose-finding cohortPhase 2 dosePhase Ib studyPhase Ib trialAnti-HER2 therapyDose-limiting toxicityGrowth factor receptor 2Immune checkpoint blockadeClinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer.
Tsuji J, Li T, Grinshpun A, Coorens T, Russo D, Anderson L, Rees R, Nardone A, Patterson C, Lennon NJ, Cibulskis C, Leshchiner I, Tayob N, Tolaney SM, Tung N, McDonnell DP, Krop IE, Winer EP, Stewart C, Getz G, Jeselsohn R. Clinical Efficacy and Whole-Exome Sequencing of Liquid Biopsies in a Phase IB/II Study of Bazedoxifene and Palbociclib in Advanced Hormone Receptor-Positive Breast Cancer. Clinical Cancer Research 2022, 28: 5066-5078. PMID: 36215125, PMCID: PMC9722539, DOI: 10.1158/1078-0432.ccr-22-2305.Peer-Reviewed Original ResearchConceptsProgression-free survivalPhase Ib/II studyCombination of palbociclibBreast cancerWhole-exome sequencingESR1 mutationsII studyClinical efficacySafety profileHormone receptor-positive/HER2-negative advanced breast cancerAdvanced hormone receptor-positive breast cancerHER2-negative advanced breast cancerHormone receptor-positive breast cancerThird-generation selective estrogen receptor modulatorMedian progression-free survivalEndocrine-resistant breast cancerReceptor-positive breast cancerShorter progression-free survivalSelective estrogen receptor modulatorsClinical benefit rateAcceptable safety profileAdvanced breast cancerEstrogen receptor modulatorsSelective ER degraderDNA whole-exome sequencing