2021
Molecular correlates of response to eribulin and pembrolizumab in hormone receptor-positive metastatic breast cancer
Keenan TE, Guerriero JL, Barroso-Sousa R, Li T, O’Meara T, Giobbie-Hurder A, Tayob N, Hu J, Severgnini M, Agudo J, Vaz-Luis I, Anderson L, Attaya V, Park J, Conway J, He MX, Reardon B, Shannon E, Wulf G, Spring LM, Jeselsohn R, Krop I, Lin NU, Partridge A, Winer EP, Mittendorf EA, Liu D, Van Allen EM, Tolaney SM. Molecular correlates of response to eribulin and pembrolizumab in hormone receptor-positive metastatic breast cancer. Nature Communications 2021, 12: 5563. PMID: 34548479, PMCID: PMC8455578, DOI: 10.1038/s41467-021-25769-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntigen PresentationAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBreast NeoplasmsCytokinesDrug Resistance, NeoplasmEstrogensFemaleFuransGene Expression ProfilingGenetic HeterogeneityGenome, HumanGenomicsHumansImmune Checkpoint InhibitorsKetonesLymphocytes, Tumor-InfiltratingMaleMiddle AgedMutationNeoplasm MetastasisReceptors, EstrogenReceptors, ProgesteroneSignal TransductionSurvival RateTreatment OutcomeConceptsImmune checkpoint inhibitorsBreast cancerHormone receptor-positive metastatic breast cancerHormone receptor-positive breast cancerFinal overall survival resultsRandomized phase 2 trialReceptor-positive breast cancerMinimal therapeutic effectPhase 2 trialMetastatic breast cancerOverall survival resultsPre-treatment tumorsCheckpoint inhibitorsCytokine changesICI responseCombination therapyImmune infiltrationImmunoregulatory cytokinesSurvival resultsAntigen presentationTherapeutic effectTherapeutic validationCancerMolecular correlatesTumor heterogeneity
2020
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer
Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.Peer-Reviewed Original ResearchConceptsProgression-free survivalHormone receptor-positive breast cancerReceptor-positive breast cancerPhase II trialEndocrine therapyBreast cancerII trialAR mRNACohort 1Higher AR mRNA levelsLower ESR1 mRNA levelsET-naïve patientsGrade adverse eventsPrior endocrine therapyMetastatic breast cancerAndrogen receptor inhibitorMRNA levelsAR mRNA levelsESR1 mRNA levelsEnzalutamide armITT populationTreat populationAdvanced diseasePrimary endpointAdverse eventsPhase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer
Garrido-Castro AC, Saura C, Barroso-Sousa R, Guo H, Ciruelos E, Bermejo B, Gavilá J, Serra V, Prat A, Paré L, Céliz P, Villagrasa P, Li Y, Savoie J, Xu Z, Arteaga CL, Krop IE, Solit DB, Mills GB, Cantley LC, Winer EP, Lin NU, Rodon J. Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer. Breast Cancer Research 2020, 22: 120. PMID: 33138866, PMCID: PMC7607628, DOI: 10.1186/s13058-020-01354-y.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsClass I Phosphatidylinositol 3-KinasesDisease ProgressionFemaleHigh-Throughput Nucleotide SequencingHumansMiddle AgedMorpholinesNeoplasm MetastasisPatient SafetyProtein Kinase InhibitorsProteomicsResponse Evaluation Criteria in Solid TumorsSurvival RateTreatment OutcomeTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerProgression-free survivalPan-class I PI3K inhibitorMetastatic triple-negative breast cancerStable diseasePhase 2 studyBreast cancerOverall survivalPI3K inhibitorsPI3K pathwayPartial responseComplete responseClinical benefitSingle-arm phase 2 studyTriple-negative metastatic breast cancerMedian progression-free survivalK inhibitorsClinical benefit rateEfficacy of buparlisibK pathwayFrequent adverse eventsMedian overall survivalPercent of patientsMetastatic breast cancerSubset of patientsClinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab
Magbanua MJM, Savenkov O, Asmus EJ, Ballman KV, Scott JH, Park JW, Dickler M, Partridge A, Carey LA, Winer EP, Rugo HS. Clinical Significance of Circulating Tumor Cells in Hormone Receptor–positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab. Clinical Cancer Research 2020, 26: 4911-4920. PMID: 32586939, PMCID: PMC7501177, DOI: 10.1158/1078-0432.ccr-20-1329.Peer-Reviewed Original ResearchConceptsProgression-free survivalCTC-positive patientsHormone receptor-positive metastatic breast cancer patientsMetastatic breast cancer patientsAddition of bevacizumabBreast cancer patientsOverall survivalCancer patientsPredictive valueMean survival time analysisMedian progression-free survivalWorse progression-free survivalAssociation of CTCsCTC-negative patientsFirst-line settingRisk of progressionCox regression modelPotential predictive valueML of bloodAdditional time pointsCirculating Tumor CellsLetrozole armOS benefitPFS benefitMultivariable analysisTumor 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 linesSensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer
Parsons HA, Rhoades J, Reed SC, Gydush G, Ram P, Exman P, Xiong K, Lo CC, Li T, Fleharty M, Kirkner GJ, Rotem D, Cohen O, Yu F, Fitarelli-Kiehl M, Leong KW, Hughes ME, Rosenberg SM, Collins LC, Miller KD, Blumenstiel B, Trippa L, Cibulskis C, Neuberg DS, DeFelice M, Freeman SS, Lennon NJ, Wagle N, Ha G, Stover DG, Choudhury AD, Getz G, Winer EP, Meyerson M, Lin NU, Krop I, Love JC, Makrigiorgos GM, Partridge AH, Mayer EL, Golub TR, Adalsteinsson VA. Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer. Clinical Cancer Research 2020, 26: 2556-2564. PMID: 32170028, PMCID: PMC7654718, DOI: 10.1158/1078-0432.ccr-19-3005.Peer-Reviewed Original ResearchConceptsMinimal residual diseaseMetastatic breast cancerDigital droplet PCRBreast cancerTumor mutationsResidual diseaseMRD detectionEarly-stage breast cancerCurative-intent treatmentCohort of patientsEarly-stage diseaseMedian lead timeClinical data collectionWhole-exome sequencingMRD testFirst positive sampleDistant recurrenceMost patientsMetastatic diagnosisStage 0PatientsPlasma samplingClinical sensitivityPatient-specific mutationsCfDNA samples
2019
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA, Investigators I. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology 2019, 21: 44-59. PMID: 31786121, DOI: 10.1016/s1470-2045(19)30689-8.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPaclitaxelPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateTriple Negative Breast NeoplasmsYoung AdultConceptsMetastatic triple-negative breast cancerInterim overall survival analysisTriple-negative breast cancerOverall survival analysisTreatment-related deathsMedian overall survivalNab-paclitaxelPhase 3 trialOverall survivalTreat populationBreast cancerSurvival analysisAtezolizumab groupPlacebo groupInterim analysisTreatment groupsEastern Cooperative Oncology Group performance statusDay 1Interactive voice-web response systemInvestigator-assessed progression-free survivalMeaningful overall survival benefitNew treatment-related deathsProgression-free survival resultsSolid Tumors version 1.1Tumor-infiltrating immune cellsRandomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.
Muss HB, Polley MC, Berry DA, Liu H, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Kartcheske PA, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Sutton LM, Magrinat G, Parker BA, Hart RD, Grenier D, Hurria A, Jatoi A, Norton L, Hudis CA, Winer EP, Carey L. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. Journal Of Clinical Oncology 2019, 37: 2338-2348. PMID: 31339827, PMCID: PMC6900836, DOI: 10.1200/jco.19.00647.Peer-Reviewed Original ResearchConceptsRecurrence-free survivalStandard adjuvant chemotherapyEarly breast cancerAdjuvant chemotherapyAge 65 yearsStandard chemotherapyBreast cancerOlder womenBreast cancer-specific survival ratesSurvival rateHormone receptor-negative diseaseHormone receptor-negative patientsHormone receptor-positive patientsCancer-specific survival ratesPatients age 65 yearsWomen age 65 yearsReceptor-negative patientsReceptor-positive patientsOverall survival benefitPrimary end pointReceptor-negative diseaseOverall survival rateAdaptive Bayesian designNonbreast cancersRFS ratesEvaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor–positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials
Martín M, Loibl S, Hyslop T, De la Haba-Rodríguez J, Aktas B, Cirrincione CT, Mehta K, Barry WT, Morales S, Carey LA, Garcia-Saenz JA, Partridge A, Martinez-Jañez N, Hahn O, Winer E, Guerrero-Zotano A, Hudis C, Casas M, Rodriguez-Martin C, Furlanetto J, Carrasco E, Dickler MN, Group G, GBG, Oncology A. Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor–positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials. European Journal Of Cancer 2019, 117: 91-98. PMID: 31276981, PMCID: PMC6718694, DOI: 10.1016/j.ejca.2019.06.002.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBone NeoplasmsBreast NeoplasmsEvaluation Studies as TopicFemaleFollow-Up StudiesFulvestrantHumansLetrozoleMiddle AgedNeoplasm Recurrence, LocalPrognosisReceptors, EstrogenReceptors, ProgesteroneSoft Tissue NeoplasmsSurvival RateTamoxifenConceptsProgression-free survivalClinical benefit rateObjective response rateEndocrine therapyMetastatic breast cancerOverall survivalGrade IIIBreast cancerHormone receptor-positive metastatic breast cancerMedian progression-free survivalAddition of BevSignificant additional toxicityStandard endocrine therapyDe novo diseaseAddition of bevacizumabFirst-line treatmentPredictors of efficacyNovo diseaseRecurrent diseaseLiver eventsEndocrine sensitivityBenefit rateAdditional toxicityPatientsResponse rateRibociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial
Goel S, Pernas S, Tan-Wasielewski Z, Barry WT, Bardia A, Rees R, Andrews C, Tahara RK, Trippa L, Mayer EL, Winer EP, Spring LM, Tolaney SM. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clinical Breast Cancer 2019, 19: 399-404. PMID: 31235441, DOI: 10.1016/j.clbc.2019.05.010.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerAdvanced HER2-positive breast cancerProgression-free survivalBreast cancerAdverse eventsObjective responseGrade 3 adverse eventsGrade 4/5 adverse eventsHormone receptor-positive diseaseMedian progression-free survivalAnti-HER2 combinationClinical benefit rateHER2-negative diseasePhase 1b/2 studyPhase 1b/2 trialPrior therapy linesReceptor-positive diseaseAnti-HER2 therapyNew safety concernsCyclin-dependent kinase 4Stable diseaseExpansion cohortMetastatic settingPrior linesQTc prolongationTBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases
Freedman RA, Gelman RS, Anders CK, Melisko ME, Parsons HA, Cropp AM, Silvestri K, Cotter CM, Componeschi KP, Marte JM, Connolly RM, Moy B, Van Poznak CH, Blackwell KL, Puhalla SL, Jankowitz RC, Smith KL, Ibrahim N, Moynihan TJ, O’Sullivan C, Nangia J, Niravath P, Tung N, Pohlmann PR, Burns R, Rimawi MF, Krop IE, Wolff AC, Winer EP, Lin NU, . TBCRC 022: A Phase II Trial of Neratinib and Capecitabine for Patients With Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases. Journal Of Clinical Oncology 2019, 37: jco.18.01511. PMID: 30860945, PMCID: PMC6494354, DOI: 10.1200/jco.18.01511.Peer-Reviewed Original ResearchConceptsCNS objective response rateObjective response rateHER2-positive breast cancer brain metastasesBreast cancer brain metastasesCancer brain metastasesBrain metastasesBreast cancerCommon grade 3 toxicitiesHER2-positive brain metastasesMedian progression-free survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorEfficacy of HER2Non-CNS progressionGrade 3 toxicityPrimary end pointPhase II trialProgression-free survivalGrowth factor receptor 2Positive breast cancerProgressive neurologic signsEvidence-based treatmentsFactor receptor 2Epidermal growth factor receptorBreast Cancer Treatment
Waks AG, Winer EP. Breast Cancer Treatment. JAMA 2019, 321: 288-300. PMID: 30667505, DOI: 10.1001/jama.2018.19323.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerNonmetastatic breast cancerTriple-negative tumorsBreast cancerSystemic therapyTumor subtypesMetastatic triple-negative breast cancerHormone receptor-positive tumorsBreast cancer-specific survivalHuman epidermal growth factor 2Epidermal growth factor 2Small-molecule inhibitor therapyMajor tumor subtypesCancer-specific survivalMedian overall survivalProgesterone receptor expressionMetastatic breast cancerTime of diagnosisReceptor-positive tumorsBreast cancer treatmentErbB2-positive tumorsPreoperative treatment responseERBB2 gene amplificationDistinct risk profilesPalliating symptoms
2018
Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade
Metzger‐Filho O, Ferreira AR, Jeselsohn R, Barry WT, Dillon DA, Brock JE, Vaz‐Luis I, Hughes ME, Winer EP, Lin NU. Mixed Invasive Ductal and Lobular Carcinoma of the Breast: Prognosis and the Importance of Histologic Grade. The Oncologist 2018, 24: e441-e449. PMID: 30518616, PMCID: PMC6656459, DOI: 10.1634/theoncologist.2018-0363.Peer-Reviewed Original ResearchConceptsInvasive lobular carcinomaDisease-free survivalHistologic gradeLobular carcinomaPostmenopausal womenSystemic therapyBetter prognosisAromatase inhibitorsPrognostic powerDisease-free survival advantageEarly-stage breast cancerFavorable disease-free survivalCox proportional hazards modelAdjuvant aromatase inhibitorsBaseline clinicopathologic characteristicsDetailed clinical databaseHER2-negative diseaseRetrospective cohort studyImportant prognostic factorKaplan-Meier methodProportional hazards modelIntermediate histologic gradeDistinct disease subtypesCohort studyOverall prognosisUpdated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O’Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Annals Of Oncology 2018, 29: 1541-1547. PMID: 29718092, DOI: 10.1093/annonc/mdy155.Peer-Reviewed Original ResearchMeSH KeywordsAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodFemaleFollow-Up StudiesHumansLetrozoleLiver NeoplasmsLung NeoplasmsLymphatic MetastasisNeoplasm Recurrence, LocalPrognosisPurinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateConceptsProgression-free survivalFirst-line ribociclibOverall response rateMONALEESA-2 studySecondary end pointsAdvanced breast cancerBreast cancerEnd pointOverall survivalHER2-negative advanced breast cancerKey secondary end pointMedian progression-free survivalHuman epidermal growth factor receptorExploratory biomarker analysisExploratory end pointsImproved efficacy outcomesManageable toxicity profilePrimary end pointSecond interim analysisMetastatic breast cancerPhase III trialsESR1 mRNA levelsEpidermal growth factor receptorTP53 mutation statusBiomarker analysisBreast cancer‐specific survival by age: Worse outcomes for the oldest patients
Freedman RA, Keating NL, Lin NU, Winer EP, Vaz‐Luis I, Lii J, Exman P, Barry WT. Breast cancer‐specific survival by age: Worse outcomes for the oldest patients. Cancer 2018, 124: 2184-2191. PMID: 29499074, PMCID: PMC5935594, DOI: 10.1002/cncr.31308.Peer-Reviewed Original ResearchConceptsBreast cancer-specific deathCancer-specific deathTriple-negative diseaseHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Growth factor receptor 2Breast cancer outcomesOlder patientsFactor receptor 2Breast cancerCancer outcomesReceptor 2Disease subtypesWorse breast cancer outcomesHR-positive diseaseCancer stage IEnd Results (SEER) dataAmerican Joint CommitteePopulation-based cohortStage of diseaseGray regression modelsAdjusted hazardClinical variablesDisease stageHigh risk
2017
Survival benefit needed to undergo chemotherapy: Patient and physician preferences
Vaz‐Luis I, O'Neill A, Sepucha K, Miller KD, Baker E, Dang CT, Northfelt DW, Winer EP, Sledge GW, Schneider B, Partridge AH. Survival benefit needed to undergo chemotherapy: Patient and physician preferences. Cancer 2017, 123: 2821-2828. PMID: 28323331, PMCID: PMC5517352, DOI: 10.1002/cncr.30671.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsAttitude of Health PersonnelAttitude to HealthBevacizumabBreast NeoplasmsChemotherapy, AdjuvantClinical Trials, Phase III as TopicCyclophosphamideDoxorubicinFemaleHumansMastectomyMastectomy, SegmentalMiddle AgedPaclitaxelPatient PreferencePhysiciansQuality of LifeRandomized Controlled Trials as TopicRisk AssessmentSurveys and QuestionnairesSurvival RateTumor BurdenConceptsMonths of chemotherapyModest survival benefitSurvival benefitAdjuvant chemotherapyEarly-stage breast cancerContemporary adjuvant chemotherapyPhase 3 trialBreast cancer patientsStage breast cancerQuality of lifeMonths of benefitsAdjuvant cyclophosphamideAdjuvant doxorubicinChemotherapy regimenMost patientsUndergoing ChemotherapyCancer patientsPatient preferencesBreast cancerModest benefitOld regimenChemotherapyPatientsPhysician's choiceSerial surveysGenomic Profiling in Node-Positive ER-Positive Early Breast Cancer: Can Tumor Biology Guide Locoregional Therapy?
Garrido-Castro AC, Winer EP. Genomic Profiling in Node-Positive ER-Positive Early Breast Cancer: Can Tumor Biology Guide Locoregional Therapy? Journal Of The National Cancer Institute 2017, 109: djw316. PMID: 28376163, DOI: 10.1093/jnci/djw316.Peer-Reviewed Original ResearchKi67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance)
Ellis MJ, Suman VJ, Hoog J, Goncalves R, Sanati S, Creighton CJ, DeSchryver K, Crouch E, Brink A, Watson M, Luo J, Tao Y, Barnes M, Dowsett M, Budd GT, Winer E, Silverman P, Esserman L, Carey L, X. C, Unzeitig G, Pluard T, Whitworth P, Babiera G, Guenther JM, Dayao Z, Ota D, Leitch M, Olson JA, Allred DC, Hunt K. Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance). Journal Of Clinical Oncology 2017, 35: jco.2016.69.440. PMID: 28045625, PMCID: PMC5455353, DOI: 10.1200/jco.2016.69.4406.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnastrozoleAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsClinical Decision-MakingFemaleFollow-Up StudiesHumansKi-67 AntigenLetrozoleMiddle AgedMitotic IndexNeoadjuvant TherapyNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingNitrilesPredictive Value of TestsPrognosisProportional Hazards ModelsReceptors, EstrogenReceptors, ProgesteroneSurvival RateTranscriptomeTriazolesConceptsPreoperative endocrine prognostic indexBreast cancerNeoadjuvant chemotherapyAmerican CollegeEstrogen receptor-positive primary breast cancerNeoadjuvant aromatase inhibitor therapyPathologic complete response rateER-positive breast cancerAromatase inhibitor therapyComplete response rateER-positive tumorsPrimary breast cancerRisk of relapseAromatase inhibitor treatmentKi67 proliferation indexEndocrine monotherapyNeoadjuvant AIsAI therapyPCR ratePostmenopausal womenInhibitor therapyCox modelingOptimal therapyPrognostic indexRelapse risk
2016
Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial
Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncology 2016, 17: 811-821. PMID: 27155741, PMCID: PMC5524539, DOI: 10.1016/s1470-2045(16)00106-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodDrug Resistance, NeoplasmEstradiolEstrogen Receptor AntagonistsFemaleFollow-Up StudiesFulvestrantHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisReceptor, ErbB-2Receptors, EstrogenSalvage TherapySurvival RateConceptsProgression-free survivalSerious adverse eventsTreatment-related serious adverse eventsWorse adverse eventsPlacebo groupAdverse eventsNon-measurable diseaseAromatase inhibitor treatmentPIK3CA mutationsBreast cancerDay 1Grade 3Inhibitor treatmentDay 15Cycle 1Median progression-free survivalHER2-negative breast cancerEndocrine-resistant breast cancerPIK3CA-mutated tumorsPhase 2 studyPhase 2 trialMetastatic breast cancerWeeks of treatmentAromatase inhibitor resistanceF Hoffmann-La Roche
2015
Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer
Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer. New England Journal Of Medicine 2015, 372: 134-141. PMID: 25564897, PMCID: PMC4313867, DOI: 10.1056/nejmoa1406281.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansInfusions, IntravenousMastectomy, SegmentalMiddle AgedNeoplasm Recurrence, LocalPaclitaxelRadiotherapyReceptor, ErbB-2Survival RateTrastuzumabConceptsHER2-positive breast cancerBreast cancerAdjuvant paclitaxelEjection fractionInvasive diseaseStage I HER2-positive breast cancerHuman epidermal growth factor receptor type 2Epidermal growth factor receptor type 2Symptomatic congestive heart failureHER2-negative breast cancerLeft ventricular ejection fractionDistant metastatic breast cancerFactor receptor type 2Discontinuation of trastuzumabGrade 3 neuropathySingle standard treatmentPrimary end pointCongestive heart failureMetastatic breast cancerVentricular ejection fractionPositive breast cancerInvestigator-initiated studyReceptor type 2Disease-specific eventsMedian follow