2022
CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer
Shepherd JH, Ballman K, Polley MC, Campbell JD, Fan C, Selitsky S, Fernandez-Martinez A, Parker JS, Hoadley KA, Hu Z, Li Y, Soloway MG, Spears PA, Singh B, Tolaney SM, Somlo G, Port ER, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon JR, Collyar D, Hahn OM, Hudis CA, Winer EP, Partridge A, Hyslop T, Carey LA, Perou CM, Sikov WM. CALGB 40603 (Alliance): Long-Term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy With or Without Carboplatin and Bevacizumab in Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2022, 40: 1323-1334. PMID: 35044810, PMCID: PMC9015203, DOI: 10.1200/jco.21.01506.Peer-Reviewed Original ResearchConceptsLong-term outcomesEvent-free survivalTriple-negative breast cancerResidual cancer burdenResidual diseaseImmune activationBreast cancerPathologic complete response rateRandomized phase II trialEnd pointSuperior long-term outcomesCox proportional hazards modelComplete response rateSecondary end pointsPhase II trialPretreatment tumor biopsiesKaplan-Meier methodOverall survival rateTumor-infiltrating lymphocytesLog-rank testPretreatment tumor samplesMinimal residual diseaseProportional hazards modelWeekly paclitaxelII trial
2021
Saci-IO TNBC: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC).
Garrido-Castro A, Keenan T, Li T, Lange P, Callahan C, Guerriero J, Tayob N, Anderson L, Yam C, Daniel B, Carey L, Nanda R, Winer E, Mittendorf E, Tolaney S. Saci-IO TNBC: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2021, 39: tps1106-tps1106. DOI: 10.1200/jco.2021.39.15_suppl.tps1106.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerProgression-free survivalImmune checkpoint inhibitorsMedian progression-free survivalRandomized phase II trialPhase II trialSacituzumab govitecanPD-L1II trialImmune cellsBreast cancerAnti-PD-1/L1 antibodyPD-1/L1 inhibitorsAntibody-dependent cellular cytotoxicityT cell effector functionTriple-negative breast cancerPrior systemic therapyPD-L1 expressionAntitumor immune responseChronic antigen stimulationHealth-related qualityKey eligibility criteriaRegulatory T cellsT cell dysfunctionCell effector functionsSaci-IO HR+: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1+ hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC).
Garrido-Castro A, Keenan T, Li T, Lange P, Callahan C, Guerriero J, Tayob N, Anderson L, Stover D, Gogineni K, Carey L, Nanda R, Winer E, Mittendorf E, Tolaney S. Saci-IO HR+: Randomized phase II trial of sacituzumab govitecan (SG) +/- pembrolizumab in PD-L1+ hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC). Journal Of Clinical Oncology 2021, 39: tps1102-tps1102. DOI: 10.1200/jco.2021.39.15_suppl.tps1102.Peer-Reviewed Original ResearchProgression-free survivalImmune checkpoint inhibitorsMedian progression-free survivalRandomized phase II trialCombined positive scorePhase II trialSacituzumab govitecanII trialPD-L1Anti-PD-1/L1 antibodyPD-1/L1 inhibitorsHER2- metastatic breast cancerAntibody-dependent cellular cytotoxicityT cell effector functionPrior hormonal therapyPD-L1 expressionAntitumor immune responseChronic antigen stimulationHealth-related qualityKey eligibility criteriaRegulatory T cellsT cell dysfunctionCell effector functionsOne-sided alphaImmune cell receptors
2019
Randomized phase II trial of exercise, metformin, or both on metabolic biomarkers in colorectal and breast cancer survivors
Meyerhardt JA, Irwin ML, Jones LW, Zhang S, Campbell N, Brown JC, Pollak M, Sorrentino A, Cartmel B, Harrigan M, Tolaney SM, Winer E, Ng K, Abrams T, Fuchs CS, Sanft T, Douglas PS, Hu F, Ligibel JA. Randomized phase II trial of exercise, metformin, or both on metabolic biomarkers in colorectal and breast cancer survivors. JNCI Cancer Spectrum 2019, 4: pkz096. PMID: 32090192, PMCID: PMC7025659, DOI: 10.1093/jncics/pkz096.Peer-Reviewed Original ResearchBreast cancer survivorsPhase II trialCancer survivorsControl armII trialInsulin levelsRandomized phase II trialInsulin-like growth factor-1Insulin-like growth factorHomeostatic model assessmentCombination of exerciseSignificant weight lossGrowth factor-1Combination armMetformin useSecondary outcomesStandard therapyPrimary outcomeIntervention armInsulin resistanceDisease outcomeModality interventionsAnthropometric measurementsMetabolic markersMetabolic biomarkers
2018
A randomized phase II trial of carboplatin with or without nivolumab in first- or second-line metastatic TNBC.
Garrido-Castro A, Barry W, Traina T, Wesolowski R, Tung N, Keenan T, Van Allen E, Lin N, Winer E, Krop I, Tolaney S. A randomized phase II trial of carboplatin with or without nivolumab in first- or second-line metastatic TNBC. Journal Of Clinical Oncology 2018, 36: tps1118-tps1118. DOI: 10.1200/jco.2018.36.15_suppl.tps1118.Peer-Reviewed Original Research
2014
Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III Study of Iniparib Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin in Patients With Metastatic Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2014, 32: 3840-3847. PMID: 25349301, DOI: 10.1200/jco.2014.55.2984.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCarboplatinDeoxycytidineDisease ProgressionDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProportional Hazards ModelsRisk FactorsTime FactorsTreatment OutcomeTriple Negative Breast NeoplasmsUnited StatesConceptsMetastatic triple-negative breast cancerProgression-free survivalTriple-negative breast cancerCoprimary end pointsOverall survivalBreast cancerRandomized phase II trialEnd pointStage IV/Clinical benefit ratePhase II trialPhase III studyPhase III trialsStandard of careWarrants further evaluationLack of treatmentCarboplatin areaITT populationPrevious chemotherapyPrior chemotherapyII trialIII studyIII trialsSurvival benefitSafety profileImpact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance). Journal Of Clinical Oncology 2014, 33: 13-21. PMID: 25092775, PMCID: PMC4268249, DOI: 10.1200/jco.2014.57.0572.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCyclophosphamideDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFatigueFemaleHumansHypertensionMiddle AgedNeoadjuvant TherapyNeoplasm StagingNeutropeniaPaclitaxelRemission InductionThrombocytopeniaTreatment OutcomeTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerPathologic complete responseNeoadjuvant chemotherapyBreast/axillaStage IIBreast cancerPathologic complete response rateRandomized phase II trialAddition of carboplatinDose-dense doxorubicinRole of carboplatinComplete response ratePhase II trialStandard neoadjuvant chemotherapyThird of patientsAdjuvant trialsConcurrent carboplatinSkipped dosesWeek paclitaxelEarly discontinuationII trialPostoperative complicationsThromboembolic eventsDose modificationOverall survival
2012
TBCRC 001: Randomized Phase II Study of Cetuximab in Combination With Carboplatin in Stage IV Triple-Negative Breast Cancer
Carey LA, Rugo HS, Marcom PK, Mayer EL, Esteva FJ, Ma CX, Liu MC, Storniolo AM, Rimawi MF, Forero-Torres A, Wolff AC, Hobday TJ, Ivanova A, Chiu WK, Ferraro M, Burrows E, Bernard PS, Hoadley KA, Perou CM, Winer EP. TBCRC 001: Randomized Phase II Study of Cetuximab in Combination With Carboplatin in Stage IV Triple-Negative Breast Cancer. Journal Of Clinical Oncology 2012, 30: 2615-2623. PMID: 22665533, PMCID: PMC3413275, DOI: 10.1200/jco.2010.34.5579.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCarboplatinCetuximabDisease ProgressionFemaleHumansMiddle AgedNeoplasm StagingReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSignal TransductionSurvival AnalysisTreatment OutcomeConceptsTriple-negative breast cancerMetastatic triple-negative breast cancerOverall survivalResponse rateBreast cancerEpidermal growth factor receptorMost triple-negative breast cancersRandomized phase II trialBasal-like molecular subtypeBasal-like breast cancerEGFR pathwayArchival tissuePhase II studyPrimary end pointDays of therapyPhase II trialStrong preclinical dataEGFR antibody cetuximabFresh tumor tissueCombination cetuximabConcomitant therapyGrowth factor receptorCarboplatin regimenDisease stabilizationII trial
2010
Randomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer.
Sikov W, Perou C, Golshan M, Collyar D, Berry D, Hahn O, Singh B, Hudis C, Winer E. Randomized phase II trial of adding carboplatin and/or bevacizumab to neoadjuvant weekly paclitaxel and dose-dense AC in triple-negative breast cancer. Journal Of Clinical Oncology 2010, 28: tps110-tps110. DOI: 10.1200/jco.2010.28.15_suppl.tps110.Peer-Reviewed Original Research
2006
Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules
Burstein HJ, Overmoyer B, Gelman R, Silverman P, Savoie J, Clarke K, Dumadag L, Younger J, Ivy P, Winer EP. Rebeccamycin analog for refractory breast cancer: A randomized phase II trial of dosing schedules. Investigational New Drugs 2006, 25: 161-164. PMID: 16969707, DOI: 10.1007/s10637-006-9007-6.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerDifferent treatment schedulesBreast cancerTreatment scheduleAdjuvant chemotherapyArm 2Arm 1Response rateAnthracycline-based adjuvant chemotherapyRefractory advanced breast cancerRandomized phase II trialPrior chemotherapy regimensRefractory breast cancerModest clinical activityPhase II trialPrimary study endpointMetastatic breast cancerCentral venous accessAnemia 5Eligible patientsMeasurable diseaseNausea/Prior chemotherapyStable diseaseChemotherapy regimens