2024
A Phase II Study of Atezolizumab, Pertuzumab, and High-Dose Trastuzumab for Central Nervous System Metastases in Patients with HER2-Positive Breast Cancer
Giordano A, Kumthekar P, Jin Q, Kurt B, Ren S, Li T, Leone J, Mittendorf E, Pereslete A, Sharp L, Davis R, DiLullo M, Tayob N, Mayer E, Winer E, Tolaney S, Lin N. A Phase II Study of Atezolizumab, Pertuzumab, and High-Dose Trastuzumab for Central Nervous System Metastases in Patients with HER2-Positive Breast Cancer. Clinical Cancer Research 2024, 30: of1-of10. PMID: 39226397, PMCID: PMC11528201, DOI: 10.1158/1078-0432.ccr-24-1161.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesClinical benefit rateCancer brain metastasesCentral nervous systemCNS responseBrain metastasesOverall response rateOverall survivalAny-grade adverse eventsEffective systemic therapy optionsNeuro-Oncology Brain MetastasesHER2-positive breast cancerIntracranial partial responseSystemic therapy optionsPhase II studyPhase II trialCNS ORRRANO-BMDose delaysPartial responseII studyPrimary endpointHigh-doseBenefit rateNeratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆
Freedman R, Heiling H, Li T, Trapani D, Tayob N, Smith K, Davis R, Pereslete A, DeMeo M, Cotter C, Chen W, Parsons H, Santa-Maria C, Van Poznak C, Moy B, Brufsky A, Melisko M, O’Sullivan C, Ashai N, Rauf Y, Nangia J, Burns R, Savoie J, Wolff A, Winer E, Rimawi M, Krop I, Lin N. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆. Annals Of Oncology 2024, 35: 993-1002. PMID: 38977064, DOI: 10.1016/j.annonc.2024.07.245.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesT-DM1Ado-trastuzumab emtansineCentral nervous systemOverall survivalCNS objective response rateEfficacy of neratinibT-DM1 exposureObjective response rateCancer brain metastasesPhase II studyMedian OSRANO-BMBrain MetastasesSlow accrualIntracranial activityII studyPrimary endpointPreclinical dataCohort 4Response assessmentTreatment optionsNeratinibPatients
2023
A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer
Mayer E, Tayob N, Ren S, Savoie J, Spigel D, Burris H, Ryan P, Harris L, Winer E, Burstein H. A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer. Breast Cancer Research And Treatment 2023, 204: 123-132. PMID: 38019444, DOI: 10.1007/s10549-023-07167-9.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalAdvanced breast cancerPhase II studyMetastatic breast cancerOverall survivalArm ABreast cancerArm BII studyMetronomic chemotherapyRandomized phase II studyGrade adverse eventsMetronomic oral cyclophosphamideOral metronomic chemotherapyMedian overall survivalStandard-dose chemotherapyFurther clinical evaluationMetronomic cyclophosphamideOral cyclophosphamideArm B.Primary endpointSecondary endpointsAdverse eventsDose chemotherapyPhase II trial of pembrolizumab in patients with brain metastases.
Brastianos P, Kim A, Giobbie-Hurder A, Lee E, Lin N, Overmoyer B, Wen P, Nayak L, Cohen J, Dietrich J, Heist R, Krop I, Lawrence D, Mayer E, Winer E, Shih H, Oh K, Cahill D, Gerstner E, Sullivan R. Phase II trial of pembrolizumab in patients with brain metastases. Journal Of Clinical Oncology 2023, 41: 2006-2006. DOI: 10.1200/jco.2023.41.16_suppl.2006.Peer-Reviewed Original ResearchBrain metastasesPrimary endpointBenefit rateEvaluable patientsLung cancerBreast cancerTherapeutic strategiesSingle-arm phase 2 clinical trialNon-small cell lung cancerHormone receptor-positive diseaseSmall cell lung cancerPhase 2 clinical trialGrade 4 toxicityLogical therapeutic strategyRECIST 1.1 criteriaMedian overall survivalPD-1 blockadePD-1 inhibitorsPrimary efficacy endpointReceptor-positive diseasePhase II trialImmune-based strategiesTriple-negative subtypeCell lung cancerT cell cytotoxicity
2022
A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer
Waks AG, Desai NV, Li T, Poorvu PD, Partridge AH, Sinclair N, Spring LM, Faggen M, Constantine M, Metzger O, Alberti J, Deane J, Rosenberg SM, Frank E, Tolaney SM, Krop IE, Tung NM, Tayob N, King TA, Mittendorf EA, Winer EP. A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer. Npj Breast Cancer 2022, 8: 63. PMID: 35538105, PMCID: PMC9091255, DOI: 10.1038/s41523-022-00429-7.Peer-Reviewed Original ResearchPathologic complete responseProspective trialBreast cancerSingle-arm prospective trialHER2-positive breast cancerHuman epidermal growth factor receptorAdjuvant treatment plansDose of THPEarly-stage HER2Incomplete clinical responsePrimary feasibility endpointTrastuzumab/pertuzumabMajority of patientsOngoing prospective trialsStage II tumorsLong-term efficacyBreast cancer recurrenceEpidermal growth factor receptorAdjuvant chemotherapyFeasibility endpointsGrowth factor receptorNeoadjuvant regimenAdjuvant therapyDoublet therapyPrimary endpoint
2021
SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Tayob N, Pereslete A, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2021, 3: iv9-iv9. DOI: 10.1093/noajnl/vdab112.034.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORMetastasis (TNM) criteriaBrain metastasesII trialMetastasis resectionNivolumab in combination with cabozantinib for metastatic triple-negative breast cancer: a phase II and biomarker study
Barroso-Sousa R, Keenan TE, Li T, Tayob N, Trippa L, Pastorello RG, Richardson III ET, Dillon D, Amoozgar Z, Overmoyer B, Schnitt SJ, Winer EP, Mittendorf EA, Van Allen E, Duda DG, Tolaney SM. Nivolumab in combination with cabozantinib for metastatic triple-negative breast cancer: a phase II and biomarker study. Npj Breast Cancer 2021, 7: 110. PMID: 34433812, PMCID: PMC8387440, DOI: 10.1038/s41523-021-00287-9.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTumor-infiltrating lymphocytesTriple-negative breast cancerObjective response ratePD-L1Primary endpointBreast cancerSingle-arm phase II studyHigh tumor-infiltrating lymphocytesLow tumor mutational burdenSafety of cabozantinibPhase II studyImmune checkpoint moleculesHigher pretreatment levelsTumor mutational burdenImmune gene expressionRECIST 1.1Checkpoint moleculesII studyImmunosuppressive cytokinesPartial responseNegative tumorsPositive tumorsTumor immunosuppressionRapid progressionPhase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations
Xu J, Keenan TE, Overmoyer B, Tung NM, Gelman RS, Habin K, Garber JE, Ellisen LW, Winer EP, Goss PE, Yeap BY, Chabner BA, Isakoff SJ. Phase II trial of veliparib and temozolomide in metastatic breast cancer patients with and without BRCA1/2 mutations. Breast Cancer Research And Treatment 2021, 189: 641-651. PMID: 34417675, DOI: 10.1007/s10549-021-06292-7.Peer-Reviewed Original ResearchConceptsObjective response rateClinical benefit rateProgression-free survivalMedian progression-free survivalMetastatic breast cancer patientsPhase II trialMetastatic breast cancerBreast cancer patientsBRCA1/2 carriersBreast cancerExpansion cohortII trialPrimary endpointPrimary cohortCancer patientsBenefit rateBRCA1/2 mutationsDay 1Longer median progression-free survivalSingle-arm phase II trialCommon grade 3Doses of veliparibPlatinum-naïve patientsPrior platinum therapyBRCA mutation carriersChemotherapy-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 dataMonthsAmenorrheaEmtansineMenopauseTrastuzumabPembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial
Winer EP, Lipatov O, Im SA, Goncalves A, Muñoz-Couselo E, Lee KS, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Zhou X, Karantza V, Mejia J, Cortes J, investigators K. Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial. The Lancet Oncology 2021, 22: 499-511. PMID: 33676601, DOI: 10.1016/s1470-2045(20)30754-3.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerCombined positive scoreMedian overall survivalPD-L1 combined positive scoreTreatment-related adverse eventsPhase 3 trialChemotherapy groupOverall survivalPembrolizumab groupBreast cancerAdverse eventsPrimary endpointMetastatic diseaseEastern Cooperative Oncology Group performance statusPD-L1 tumor statusCommon grade 3Durable antitumour activityInvestigator-choice chemotherapyPrevious systemic treatmentSerious adverse eventsThird-line treatmentSubpopulation of patientsTreatment of patientsSingle-drug chemotherapy
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 eventsTBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes.
Tung NM, Robson ME, Ventz S, Santa-Maria CA, Nanda R, Marcom PK, Shah PD, Ballinger TJ, Yang ES, Vinayak S, Melisko M, Brufsky A, DeMeo M, Jenkins C, Domchek S, D'Andrea A, Lin NU, Hughes ME, Carey LA, Wagle N, Wulf GM, Krop IE, Wolff AC, Winer EP, Garber JE. TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes. Journal Of Clinical Oncology 2020, 38: 4274-4282. PMID: 33119476, DOI: 10.1200/jco.20.02151.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerObjective response rateProgression-free survivalPoly (ADP-ribose) polymerase (PARP) inhibitorsPhase II studyBreast cancerMutation carriersII studyMedian progression-free survivalNegative metastatic breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Clinical benefit rateHER2-negative diseasePlatinum-refractory diseaseGrowth factor receptor 2Population of patientsFactor receptor 2Homologous recombination-related genesConfirmed responsesEligible patientsMeasurable diseaseSecondary endpointsChemotherapy regimensPrimary endpointA phase Ib study of pembrolizumab (pembro) plus trastuzumab emtansine (T-DM1) for metastatic HER2+ breast cancer (MBC).
Waks A, Keenan T, Li T, Tayob N, Wulf G, Richardson E, Mittendorf E, Overmoyer B, Krop I, Winer E, Van Allen E, Agudo J, Tolaney S. A phase Ib study of pembrolizumab (pembro) plus trastuzumab emtansine (T-DM1) for metastatic HER2+ breast cancer (MBC). Journal Of Clinical Oncology 2020, 38: 1046-1046. DOI: 10.1200/jco.2020.38.15_suppl.1046.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalAdverse eventsT-DM1PD-L1 combined positive scoreTumor-infiltrating lymphocyte (TIL) statusClinical benefit rateDose-finding cohortMedian age 54Phase 2 dosePhase Ib studyCombined positive scoreAnti-PD1 antibodyPhase 1 trialDe-escalation designEligible patientsLymphocyte statusMetastatic HER2Expansion cohortOral mucositisPrimary endpointSecondary endpointsAntitumor immunityImmune signaturesPrior linesALTERNATE: Neoadjuvant endocrine treatment (NET) approaches for clinical stage II or III estrogen receptor-positive HER2-negative breast cancer (ER+ HER2- BC) in postmenopausal (PM) women: Alliance A011106.
Ma C, Suman V, Leitch A, Sanati S, Vij K, Unzeitig G, Hoog J, Watson M, Hahn O, Guenther J, Caudle A, Dockter T, Korde L, Weiss A, Hunt K, Hudis C, Winer E, Partridge A, Carey L, Ellis M. ALTERNATE: Neoadjuvant endocrine treatment (NET) approaches for clinical stage II or III estrogen receptor-positive HER2-negative breast cancer (ER+ HER2- BC) in postmenopausal (PM) women: Alliance A011106. Journal Of Clinical Oncology 2020, 38: 504-504. DOI: 10.1200/jco.2020.38.15_suppl.504.Peer-Reviewed Original ResearchHER2- BCEstrogen receptor-positive HER2-negative breast cancerClinical stage II/IIIBreast conservation surgery (BCS) ratesHER2-negative breast cancerRecurrence-free survival ratesStage II/IIIClinical stage IIPathologic complete responseWk 4Chi-square testAdjuvant chemotherapyCN1-3Neoadjuvant phasePrimary endpointAlone armPostmenopausal womenComplete responseLoading dosePM patientsBCS ratesSurgery ratesPO dailyBreast cancerLower riskA Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer
Barroso-Sousa R, Krop IE, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson ET, Pastorello RG, Winer EP, Mittendorf EA, Bellon JR, Schoenfeld JD, Tolaney SM. A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. Clinical Breast Cancer 2020, 20: 238-245. PMID: 32113750, DOI: 10.1016/j.clbc.2020.01.012.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorBreastBreast NeoplasmsCarcinoma, Ductal, BreastChemoradiotherapyDrug Administration ScheduleFemaleHumansInfusions, IntravenousMiddle AgedPalliative CareProgrammed Cell Death 1 ReceptorProgression-Free SurvivalReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneResponse Evaluation Criteria in Solid TumorsConceptsMetastatic breast cancerHormone receptor-positive metastatic breast cancerProgression-free survivalRadiation therapyObjective responseOverall survivalBreast cancerResponse rateMedian progression-free survivalCause adverse eventsGrade 3 eventsMedian prior linesMedian overall survivalObjective response ratePalliative radiation therapyPhase II studyTumor-infiltrating lymphocytesLymph node lesionsOverall response rateEpidermal growth factor receptorEligible patientsExploratory endpointsGrowth factor receptorPalliative radiotherapyPrimary endpoint
2019
TRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Trippa L, Milisits L, Andrews C, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. TRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2019, 1: i9-i9. PMCID: PMC7213424, DOI: 10.1093/noajnl/vdz014.036.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORCombination of GDCMetastasis (TNM) criteriaBrain metastasesII trialAvoiding 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 2HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial.
Metzger Filho O, Viale G, Trippa L, Li T, Yardley D, Mayer I, Abramson V, Arteaga C, Spring L, Waks A, Janiszewska M, Wrabel E, Demeo M, Bardia A, King T, Polyak K, Winer E, Krop I. HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial. Journal Of Clinical Oncology 2019, 37: 502-502. DOI: 10.1200/jco.2019.37.15_suppl.502.Peer-Reviewed Original ResearchPathologic complete responseER statusRCB 0T-DM1HER2 heterogeneitySignificant associationUltrasound-guided core biopsyRoutine pathology evaluationMedian tumor sizeProspective clinical trialsPredictors of responseAreas of tumorHigh rateCurative settingRCB-IIRCB-IIIPrimary endpointComplete responseHER2 positivityPathologic responseTherapy regimenEvaluable casesTumor sizeCore biopsyClinical trialsCALGB (Alliance) 40603: Long-term outcomes (LTOs) after neoadjuvant chemotherapy (NACT) +/- carboplatin (Cb) and bevacizumab (Bev) in triple-negative breast cancer (TNBC).
Sikov W, Polley M, Twohy E, Perou C, Singh B, Berry D, Tolaney S, Somlo G, Port E, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon J, Collyar D, Hahn O, Hudis C, Winer E, Partridge A, Carey L. CALGB (Alliance) 40603: Long-term outcomes (LTOs) after neoadjuvant chemotherapy (NACT) +/- carboplatin (Cb) and bevacizumab (Bev) in triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2019, 37: 591-591. DOI: 10.1200/jco.2019.37.15_suppl.591.Peer-Reviewed Original ResearchTriple-negative breast cancerLong-term outcomesNeoadjuvant chemotherapyPoor outcomeResidual diseaseUntreated triple-negative breast cancerBetter long-term outcomesClinical stage IIDose-dense ACPretreatment clinical stageWeeks of paclitaxelPathologic complete responseResidual cancer burdenStandard neoadjuvant chemotherapyClinical trial informationBreast/axillaBetter EFSPrimary endpointStandard chemotherapyComplete responseTreatment armsCancer burdenChemotherapy dosesClinical stageTrial arms