2025
Immune Subtyping Identifies Patients With Hormone Receptor–Positive Early-Stage Breast Cancer Who Respond to Neoadjuvant Immunotherapy (IO): Results From Five IO Arms of the I-SPY2 Trial
Wolf D, Yau C, Campbell M, Glas A, Barcaru A, Mittempergher L, Kuilman M, Brown-Swigart L, Hirst G, Basu A, Magbanua M, Sayaman R, Huppert L, Delson A, Investigators I, Symmans W, Borowsky A, Pohlmann P, Rugo H, Clark A, Yee D, DeMichele A, Perlmutter J, Petricoin E, Chien J, Stringer-Reasor E, Shatsky R, Liu M, Han H, Soliman H, Isaacs C, Nanda R, Hylton N, Pusztai L, Esserman L, van ‘t Veer L, Mukhtar R, Melisko M, Wallace A, Yeung K, Albain K, Robinson P, Lo S, Olopade F, Potter D, Beckwith H, Blaes A, Boughey J, Haddad T, Elias A, Isaacs C, Mitri Z, Kemmer K, Lu J, Lang J, Thomas A, Trivedi M, Hershman D, Meisel J, Kalinsky K, Vaklavas C, Williams N, Ellis E, Sanford A, Sanft T, Viscusi R, Arora M, Falkson C, Northfelt D, Murthy R, Haley B, Yung R, Mayer I, Khan Q, Edmiston K. Immune Subtyping Identifies Patients With Hormone Receptor–Positive Early-Stage Breast Cancer Who Respond to Neoadjuvant Immunotherapy (IO): Results From Five IO Arms of the I-SPY2 Trial. JCO Precision Oncology 2025, 9: e2400776. PMID: 40526879, PMCID: PMC12184982, DOI: 10.1200/po-24-00776.Peer-Reviewed Original ResearchConceptsPCR ratePredicting pathologic complete responseTriple-negative breast cancerNeoadjuvant immunotherapyTumor gradeHormone receptor-positive early-stage breast cancerHuman epidermal growth factor receptor 2-negativeBreast cancerEarly-stage triple-negative breast cancerImmune-related adverse eventsControl armEarly-stage breast cancerMammaPrint-high riskHormone receptor-positivePathological complete responseResponse to IOI-SPY2 trialStandard of careER-lowComplete responseNeoadjuvant therapyReceptor-positiveHER2+I-SPY2Adverse eventsMHC class I expression and outcomes in breast cancer in the real-world clinico-genomic data and the FinXX trial.
Liu Y, Deshmukh S, Ma Y, Carter J, Wu S, Xiu J, Norton N, Ruddy K, Ruddy K, Perez E, Gandhi S, Barreto Coelho P, Lustberg M, Goetz M, Joensuu H, Sledge G, Thompson E, Chumsri S. MHC class I expression and outcomes in breast cancer in the real-world clinico-genomic data and the FinXX trial. Journal Of Clinical Oncology 2025, 43: 570-570. DOI: 10.1200/jco.2025.43.16_suppl.570.Peer-Reviewed Original ResearchTriple-negative BCMHC-I expressionCD8+ T cellsHER2+Overall survivalI expressionBC subtypesBreast cancerMHC-IT cellsHLA-CAssociated with higher immune infiltrationDownregulation of MHC-I expressionFrequency of PD-L1 positivityHLA-AHLA-BT cell inflamed scoreExpression of HLA-AInfiltration of B cellsMHC class I expressionSubtypes of breast cancerMechanisms of immune evasionReal-world overall survivalHormone receptor-positivePD-L1 positivityCirculating tumor DNA and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer: An updated analysis of the CHiRP study.
Yoo T, Heiling H, Santos K, Lipsyc-Sharf M, De Bruin E, Patel A, Kirkner G, Hughes M, Partridge A, Krop I, Howarth K, Winer E, Tolaney S, Tayob N, Lin N, Parsons H. Circulating tumor DNA and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer: An updated analysis of the CHiRP study. Journal Of Clinical Oncology 2025, 43: 3055-3055. DOI: 10.1200/jco.2025.43.16_suppl.3055.Peer-Reviewed Original ResearchHR+/HER2- breast cancerNegative predictive valueAdjuvant settingBreast cancerFollow-upCtDNA testingDistant recurrenceClinical outcomesPlasma samplesHER2-negative breast cancerEarly-stage breast cancerRoutine surveillance imagingHormone receptor-positiveStage III diseaseYrs of follow-upMedian Follow-UpCirculating tumor DNALack of clinical recurrenceRisk of recurrenceFollow-up periodFollow-up visitMedian lead timeImpact clinical outcomesGuideline-concordant careCtDNA-negativePhase I/Ib study of inavolisib (INAVO) alone and in combination with endocrine therapy ± palbociclib (PALBO) in patients (pts) with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced/metastatic breast cancer (HR+, HER2– LA/mBC): Analysis of hyperglycemia (HG) in prediabetic/obese pts.
Oliveira M, Accordino M, Cervantes A, Gambardella V, Hamilton E, Italiano A, Jhaveri K, Juric D, Kalinsky K, Krop I, Saura C, Schmid P, Turner N, Varga A, Jin Y, Lim S, Royer-Joo S, Shankar N, Schutzman J, Bedard P. Phase I/Ib study of inavolisib (INAVO) alone and in combination with endocrine therapy ± palbociclib (PALBO) in patients (pts) with PIK3CA-mutated, hormone receptor–positive, HER2-negative locally advanced/metastatic breast cancer (HR+, HER2– LA/mBC): Analysis of hyperglycemia (HG) in prediabetic/obese pts. Journal Of Clinical Oncology 2025, 43: 1004-1004. DOI: 10.1200/jco.2025.43.16_suppl.1004.Peer-Reviewed Original ResearchPhase I/IB StudyAdverse eventsPI3K inhibitorsDose interruptionStarting doseLocally advanced/metastatic breast cancerMedian time to onsetRisk factorsMedian time to improvementMedian starting doseHormone receptor-positiveAdvanced/Metastatic Breast CancerEffects of PI3K inhibitorsTime to improvementOn-target side effectsClinical cut-offTime to onsetBaseline risk factorsYears of ageCut-offDose intensityLaboratory glucose valuesReceptor-positiveAdvanced BCPIK3CA mutationsLong-term outcomes of patients with HER2-positive invasive lobular carcinoma in the ALTTO trial (BIG 2-06/NCCTG N063D [Alliance]).
Nader Marta G, Ameye L, Viale G, Martins-Branco D, Paesmans M, Aftimos P, Desmedt C, Choudhury A, Wolff A, Krop I, Piccart-Gebhart M, de Azambuja E. Long-term outcomes of patients with HER2-positive invasive lobular carcinoma in the ALTTO trial (BIG 2-06/NCCTG N063D [Alliance]). Journal Of Clinical Oncology 2025, 43: 542-542. DOI: 10.1200/jco.2025.43.16_suppl.542.Peer-Reviewed Original ResearchTime to distant recurrenceInvasive lobular carcinomaNo special typeDisease-free survivalCentral nervous system recurrenceCentral pathology reviewTrastuzumab-containing armsCentral nervous systemOutcomes of patientsLong-term outcomesOverall survivalHistological subtypesALTTO trialPathology reviewLobular carcinomaBreast cancerHistological subtype of breast cancerLong-term outcomes of patientsIncidence of CNS metastasesRandomized phase III trialSubtypes of breast cancerProportion of invasive lobular carcinomasLocal pathologyHormone receptor-positivePattern of relapseClinicogenomic characterization of inflammatory breast cancer.
Priedigkeit N, Harrison B, Shue R, Hughes M, Li Y, Lebrón-Torres A, Kirkner G, Spurr L, Remolano M, Strauss S, Files J, Feeney A, Grant L, Mohammed-Abreu A, Garrido-Castro A, Barroso Sousa R, Bychkovsky B, Nakhlis F, Bellon J, King T, Winer E, Lindeman N, Johnson B, Sholl L, Dillon D, Overmoyer B, Tolaney S, Cherniack A, Lin N, Lynce F. Clinicogenomic characterization of inflammatory breast cancer. Clinical Cancer Research 2025, of1-of12. PMID: 40378057, DOI: 10.1158/1078-0432.ccr-24-2081.Peer-Reviewed Original ResearchInflammatory breast cancerTumor mutational burdenNon-IBC casesNon-IBCCopy number variantsSingle nucleotide variantsSomatic alterationsPoor outcomeMetastatic inflammatory breast cancerAssociated with poor outcomesFrequent somatic alterationsHER2+ diseaseHormone receptor-positiveNotch pathway alterationsCohort of patientsClinically distinct formsIBC pathogenesisMultivariate logistic regressionReceptor-positiveHER2+TP53 mutationsRB1 alterationsAggressive diseaseMutational burdenSurvival outcomes325P Net treatment benefit (NTB) from either endocrine therapy plus palbociclib (ET/P) or capecitabine (C) in GEICAM/2013-02_PEARL, a phase III trial in hormone receptor-positive, HER2-negative metastatic breast cancer
Bermejo B, Salvaggio S, Saenz J, Ciani O, Saad E, Carrasco E, Chiem J, Casas M, Gil M, Borrego M, Ciruelos E, Munoz M, Vila M, Torres A, Kahan Z, Csoszi T, Gauthier E, Zielinski C, Buyse M, Jimenez M. 325P Net treatment benefit (NTB) from either endocrine therapy plus palbociclib (ET/P) or capecitabine (C) in GEICAM/2013-02_PEARL, a phase III trial in hormone receptor-positive, HER2-negative metastatic breast cancer. ESMO Open 2025, 10: 104897. DOI: 10.1016/j.esmoop.2025.104897.Peer-Reviewed Original Research
2024
Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial
Abdou Y, Barlow W, Gralow J, Meric-Bernstam F, Albain K, Hayes D, Lin N, Perez E, Goldstein L, Chia S, Dhesy-Thind S, Rastogi P, Alba E, Delaloge S, Schott A, Shak S, Sharma P, Lew D, Miao J, Unger J, Tripathy D, Hortobagyi G, Pusztai L, Kalinsky K. Race and clinical outcomes in hormone receptor-positive, HER2-negative, node-positive breast cancer in the randomized RxPONDER trial. Journal Of The National Cancer Institute 2024, 117: 889-897. PMID: 39656951, PMCID: PMC12058262, DOI: 10.1093/jnci/djae314.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveRecurrence scoreRxPONDER trialClinical outcomesReceptor-positiveBreast cancerHER2-negative breast cancerNode-positive breast cancerDisease-free survivalMultivariate Cox modelBreast cancer outcomesBody mass indexHER2-negativePositive nodesTumor sizeSurvival outcomesClinicopathological characteristicsClinical characteristicsMass indexSelf-reported race/ethnicityCancer outcomesSecondary outcomesNHB womenTreatment efficacyDevelopment and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor–Positive, Node-Positive Breast Cancer
Pusztai L, Hoag J, Albain K, Barlow W, Stemmer S, Meisner A, Hortobagyi G, Shak S, Rae J, Baehner R, Sharma P, Kalinsky K. Development and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor–Positive, Node-Positive Breast Cancer. Journal Of Clinical Oncology 2024, 43: 919-928. PMID: 39621968, PMCID: PMC11885031, DOI: 10.1200/jco-24-01507.Peer-Reviewed Original ResearchChemoendocrine therapyRecurrence scorePostmenopausal womenClinicopathological factorsClinicopathological modelOncotype DX Breast Recurrence ScoreLymph node-positive breast cancerInvasive disease-free survivalNode-positive breast cancerHormone receptor-positiveNode-positive diseaseDisease-free survivalCox proportional hazards regression modelsIndividual recurrence riskProportional hazards regression modelsRisk estimatesHealth Service RegistryEstimation of prognosisHazards regression modelsPremenopausal patientsEndocrine therapyReceptor-positiveChemotherapy benefitMenopausal statusPatient-level dataTrends in breast cancer–specific death by clinical stage at diagnoses between 2000 and 2017
Marczyk M, Kahn A, Silber A, Rosenblit M, Digiovanna M, Lustberg M, Pusztai L. Trends in breast cancer–specific death by clinical stage at diagnoses between 2000 and 2017. Journal Of The National Cancer Institute 2024, 117: 287-295. PMID: 39348186, DOI: 10.1093/jnci/djae241.Peer-Reviewed Original ResearchBreast cancer-specific deathCancer-specific deathBreast cancerStage IAll-Cause MortalityTemporal trendsStage I/II breast cancerHormone receptor-positiveNode-negative cancersPrimary tumor typeStage I/II diseaseMetastatic breast cancerStage II cancerBilateral cancerIV cancerFemale sexIV diseaseReceptor-positiveExcellent prognosisII cancerClinical stageTumor typesTreated patientsStage IIICancerPhase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer
Jhaveri K, Accordino M, Bedard P, Cervantes A, Gambardella V, Hamilton E, Italiano A, Kalinsky K, Krop I, Oliveira M, Schmid P, Saura C, Turner N, Varga A, Cheeti S, Hilz S, Hutchinson K, Jin Y, Royer-Joo S, Peters U, Shankar N, Schutzman J, Juric D. Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3947-3956. PMID: 39236276, PMCID: PMC11575912, DOI: 10.1200/jco.24.00110.Peer-Reviewed Original ResearchTreatment-related adverse eventsDrug-drug interactionsPreliminary antitumor activityEndocrine therapyStudy treatmentHuman epidermal growth factor receptor 2-negativeBreast cancerTreatment-related adverse event ratesLack of drug-drug interactionsConfirmed objective response rateLocally advanced/metastatic breast cancerCirculating tumor DNA analysisEffect of study treatmentPK drug-drug interactionsAntitumor activityObjective response ratePhase I/IB StudyHormone receptor-positiveProgression-free survivalAdvanced/Metastatic Breast CancerTumor DNA analysisBiomarkers of responseMetastatic breast cancerYears of ageReceptor-positivePhase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer
Chavez-MacGregor M, Miao J, Pusztai L, Goetz M, Rastogi P, Ganz P, Mamounas E, Paik S, Bandos H, Razaq W, O'Dea A, Kaklamani V, Silber A, Flaum L, Andreopoulou E, Wendt A, Carney J, Sharma P, Gralow J, Lew D, Barlow W, Hortobagyi G. Phase III Randomized, Placebo-Controlled Trial of Endocrine Therapy ± 1 Year of Everolimus in Patients With High-Risk, Hormone Receptor–Positive, Early-Stage Breast Cancer. Journal Of Clinical Oncology 2024, 42: 3012-3021. PMID: 38833643, PMCID: PMC11565489, DOI: 10.1200/jco.23.02344.Peer-Reviewed Original ResearchInvasive disease-free survivalHormone receptor-positiveEndocrine therapyOverall survivalBreast cancerHazard ratioReceptor-positiveHigh riskSubset analysisHormone receptor-positive metastatic breast cancerRisk groupsHormone receptor-positive BCEarly-stage breast cancerStratified log-rank testProgression-free survivalEfficacy of everolimusDisease-free survivalMetastatic breast cancerPlacebo-controlled trialSecondary end pointsLog-rank testHighest grade 3Treatment completion ratesPhase IIIEverolimus armDevelopment and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer.
Pusztai L, Hoag J, Albain K, Barlow W, Stemmer S, Meisner A, Hortobagyi G, Shak S, Hayes D, Rae J, Baehner F, Sharma P, Kalinsky K. Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer. Journal Of Clinical Oncology 2024, 42: 508-508. DOI: 10.1200/jco.2024.42.16_suppl.508.Peer-Reviewed Original ResearchChemoendocrine therapyRecurrence scoreClinicopathological factorsBreast cancerPostmenopausal patientsNode-negative breast cancerNode-positive breast cancerHormone receptor-positiveNode-positive diseaseHR+/HER2- breast cancerRisk estimatesHigh-risk patientsEstimating 5-year riskEstimation of recurrence riskLikelihood ratioPremenopausal patientsHER2-negativeReceptor-positiveChemotherapy benefitEndocrine therapyMenopausal statusRisk patientsInvasive diseasePrognostic informationPostmenopausal modelETHAN: A phase II study comparing different endocrine therapies for male breast cancer.
Leone J, Ruddy K, Rashid N, Giordano S, Gupta G, Hilsenbeck S, Gucalp A, Walsh E, Sukumar J, Makhlin I, Ortiz-Perez T, Spanheimer P, Calhoun B, Wolff A, Krop I, Thompson A. ETHAN: A phase II study comparing different endocrine therapies for male breast cancer. Journal Of Clinical Oncology 2024, 42: tps632-tps632. DOI: 10.1200/jco.2024.42.16_suppl.tps632.Peer-Reviewed Original ResearchResidual cancer burdenMale breast cancerPreoperative endocrine prognostic indexTranslational Breast Cancer Research ConsortiumBreast cancerEndocrine therapyKi-67Patient-reported outcomesNeoadjuvant phaseArm BAromatase inhibitorsHuman epidermal growth factor receptor 2 (HER2)-negative breast cancerOutcome of endocrine therapyResidual cancer burden indexWindow phaseCyclin-dependent kinase 4/6Ki-67 reductionHormone receptor-positivePhase II studyInflammatory breast cancerLack of clinical trialsPhase II trialHR+/HER2- breast cancerAnti-cancer therapyStandard of care188P A health-related quality-of-life (HRQoL) analysis from DESTINY-Breast04: Trastuzumab deruxtecan (T-DXd) vs capecitabine (CAP) in patients (Pts) with hormone receptor-positive (HR+), HER2-low metastatic breast cancer (mBC)
Ueno N, Cottone F, Dunton K, Cardoso F, Yamashita T, Losada M, Niikura N, Zagouri F, Sohn J, Gombos A, Im S, Pierga J, Krop I, Hashimoto Y, Kim J, Gori S, Jacot W, Bauer R, Aguilar C, Modi S. 188P A health-related quality-of-life (HRQoL) analysis from DESTINY-Breast04: Trastuzumab deruxtecan (T-DXd) vs capecitabine (CAP) in patients (Pts) with hormone receptor-positive (HR+), HER2-low metastatic breast cancer (mBC). ESMO Open 2024, 9: 103210. DOI: 10.1016/j.esmoop.2024.103210.Peer-Reviewed Original Research
2022
Contemporary Use of Hormonal Therapy in Endometrial Cancer: a Literature Review
Kailasam A, Langstraat C. Contemporary Use of Hormonal Therapy in Endometrial Cancer: a Literature Review. Current Treatment Options In Oncology 2022, 23: 1818-1828. PMID: 36417148, DOI: 10.1007/s11864-022-01031-6.Peer-Reviewed Original ResearchConceptsHormone receptor-positiveRecurrent endometrial cancerLow-grade diseaseHormone therapyEndometrial cancerReceptor-positiveSurgical candidatesTreatment optionsGonadotropin-releasing hormone agonistHormone treatmentLevonorgestrel intrauterine deviceSecond-line treatmentHormonal treatment optionsEstrogen receptor modulatorsAnti-estrogen treatmentEndometrial cancer treatmentLow performance statusStandard of careOral progesteroneUpfront settingMetastatic diseaseIntrauterine deviceProgesterone receptorPerformance statusHormone agonist
2020
Clinical efficacy and molecular effects of lenvatinib (Len) and letrozole (Let) in hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Lim J, Wong A, Ow S, Ngoi N, Ang Y, Chan G, Eng L, Chong W, Choo J, Lee M, Tan H, Jan Y, Tan K, Sundar R, Tan D, Soo R, Chee C, Yong W, Goh B, Lee S. Clinical efficacy and molecular effects of lenvatinib (Len) and letrozole (Let) in hormone receptor-positive (HR+) metastatic breast cancer (MBC). Journal Of Clinical Oncology 2020, 38: 1019-1019. DOI: 10.1200/jco.2020.38.15_suppl.1019.Peer-Reviewed Original ResearchDisease control rateObjective response rateMetastatic breast cancerEffect of lenvatinibDose escalationEndocrine therapyEfficacy dataRecommended phase 2 doseAll-grade toxicitiesPhase 2 doseDose-escalation phaseHormone receptor-positiveDuration of responsePhase Ib/II studyTumor molecular profilingSerial tumor biopsiesAnti-tumor activityMolecular effectsMedian DORPrior CTPALB2 mutationsProgression-FreeExpansion cohortMBC patientsReceptor-positive
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