2022
Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial
Geyer C, Sikov W, Huober J, Rugo H, Wolmark N, O’Shaughnessy J, Maag D, Untch M, Golshan M, Lorenzo J, Metzger O, Dunbar M, Symmans W, Rastogi P, Sohn J, Young R, Wright G, Harkness C, McIntyre K, Yardley D, Loibl S. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial. Annals Of Oncology 2022, 33: 384-394. PMID: 35093516, DOI: 10.1016/j.annonc.2022.01.009.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerEvent-free survivalAddition of carboplatinNeoadjuvant chemotherapyOverall survivalHazard ratioBreast cancerEarly-stage triple-negative breast cancerPathological complete response rateRandomized phase III trialComplete response rateCyclophosphamide neoadjuvant chemotherapyManageable acute toxicitiesManageable safety profileSafety of additionUntreated stage IIStandard neoadjuvant chemotherapyPhase III trialsCo-primary endpointsLong-term efficacyAcute myeloid leukemiaWeekly paclitaxelPrimary endpointSecondary endpointsIII trials
2021
Matched cohort study of germline BRCA mutation carriers with triple negative breast cancer in brightness
Metzger-Filho O, Collier K, Asad S, Ansell PJ, Watson M, Bae J, Cherian M, O’Shaughnessy J, Untch M, Rugo HS, Huober JB, Golshan M, Sikov WM, von Minckwitz G, Rastogi P, Li L, Cheng L, Maag D, Wolmark N, Denkert C, Symmans WF, Geyer CE, Loibl S, Stover DG. Matched cohort study of germline BRCA mutation carriers with triple negative breast cancer in brightness. Npj Breast Cancer 2021, 7: 142. PMID: 34764307, PMCID: PMC8586340, DOI: 10.1038/s41523-021-00349-y.Peer-Reviewed Original ResearchTriple-negative breast cancerNeoadjuvant chemotherapyCohort studyBreast cancerInstability scoreGenomic instability scoreGermline BRCA mutation carriersPathologic complete response rateAddition of carboplatinComplete response rateStandard neoadjuvant chemotherapyLymph node statusBRCA mutation carriersGermline BRCA1/2 mutationsNegative breast cancerOverall cohortNode statusTreatment armsHigher oddsMutation carriersBRCA1/2 mutationsResponse rateCarboplatinPARP inhibitorsCancer119O Event-free survival (EFS), overall survival (OS), and safety of adding veliparib (V) plus carboplatin (Cb) or carboplatin alone to neoadjuvant chemotherapy in triple-negative breast cancer (TNBC) after ≥4 years of follow-up: BrighTNess, a randomized phase III trial
Loibl S, Sikov W, Huober J, Rugo H, Wolmark N, O'Shaughnessy J, Maag D, Untch M, Golshan M, Lorenzo J, Metzger O, Dunbar M, Symmans W, Geyer C. 119O Event-free survival (EFS), overall survival (OS), and safety of adding veliparib (V) plus carboplatin (Cb) or carboplatin alone to neoadjuvant chemotherapy in triple-negative breast cancer (TNBC) after ≥4 years of follow-up: BrighTNess, a randomized phase III trial. Annals Of Oncology 2021, 32: s408. DOI: 10.1016/j.annonc.2021.08.400.Peer-Reviewed Original ResearchApocrine Breast Cancer: Unique Features of a Predominantly Triple-Negative Breast Cancer
Saridakis A, Berger ER, Harigopal M, Park T, Horowitz N, Le Blanc J, Zanieski G, Chagpar A, Greenup R, Golshan M, Lannin DR. Apocrine Breast Cancer: Unique Features of a Predominantly Triple-Negative Breast Cancer. Annals Of Surgical Oncology 2021, 28: 5610-5616. PMID: 34426884, DOI: 10.1245/s10434-021-10518-9.Peer-Reviewed Original ResearchConceptsBreast cancer-specific survivalCancer-specific survivalHigh-grade tumorsMolecular subtypesApocrine carcinomaBreast cancerBetter survivalHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Triple-negative breast cancerRare breast cancerEnd Results (SEER) databaseGrowth factor receptor 2Triple-negative patientsTriple-negative cancersLow-grade tumorsFactor receptor 2Life table methodApocrine tumorsLuminal patientsWorse survivalClinicopathologic featuresResults databaseAggressive featuresReceptor 2Immunotherapy Treatment for Triple Negative Breast Cancer
Berger ER, Park T, Saridakis A, Golshan M, Greenup RA, Ahuja N. Immunotherapy Treatment for Triple Negative Breast Cancer. Pharmaceuticals 2021, 14: 763. PMID: 34451860, PMCID: PMC8401402, DOI: 10.3390/ph14080763.Peer-Reviewed Original ResearchTriple-negative breast cancerImmune related adverse eventsBreast cancerMetastatic settingMetastatic triple-negative breast cancerEarly breast cancer settingImmune checkpoint inhibitor therapyBreast cancer settingCheckpoint inhibitor therapyRelated adverse eventsLocal recurrence rateHigh-risk subtypesNegative breast cancerDevelopment of biomarkersTypes of cancerImmunotherapy useAdverse eventsCheckpoint therapyOverall survivalStandard therapySystemic treatmentInhibitor therapyDismal prognosisImmunotherapy treatmentRecurrence rateFactors Associated with Nodal Pathologic Complete Response Among Breast Cancer Patients Treated with Neoadjuvant Chemotherapy: Results of CALGB 40601 (HER2+) and 40603 (Triple-Negative) (Alliance)
Weiss A, Campbell J, Ballman KV, Sikov WM, Carey LA, Hwang ES, Poppe MM, Partridge AH, Ollila DW, Golshan M. Factors Associated with Nodal Pathologic Complete Response Among Breast Cancer Patients Treated with Neoadjuvant Chemotherapy: Results of CALGB 40601 (HER2+) and 40603 (Triple-Negative) (Alliance). Annals Of Surgical Oncology 2021, 28: 5960-5971. PMID: 33821344, PMCID: PMC8532250, DOI: 10.1245/s10434-021-09897-w.Peer-Reviewed Original ResearchConceptsBreast pathologic complete responsePathologic complete responseResidual breast diseaseTriple-negative breast cancerNodal pathologic complete responsePretreatment nodal statusClinical nodal statusNeoadjuvant chemotherapyNodal statusAxillary surgeryComplete responseCALGB 40601YpN0 rateAxillary nodal involvementResidual nodal diseaseProportion of patientsCareful patient selectionBreast cancer patientsNAC regimensYpN0 diseaseYpN0 statusCN0 patientsNodal diseaseNodal involvementMultivariable analysisAssociation of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer
Filho OM, Stover DG, Asad S, Ansell PJ, Watson M, Loibl S, Geyer CE, Bae J, Collier K, Cherian M, O’Shaughnessy J, Untch M, Rugo HS, Huober JB, Golshan M, Sikov WM, von Minckwitz G, Rastogi P, Maag D, Wolmark N, Denkert C, Symmans WF. Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer. JAMA Oncology 2021, 7: 603-608. PMID: 33599688, PMCID: PMC7893540, DOI: 10.1001/jamaoncol.2020.7310.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerPathologic complete responseNeoadjuvant chemotherapyGene expression-based molecular subtypesComplete responseMolecular subtypesBreast cancerClinical trialsSecondary analysisStage IIEnd pointAddition of carboplatinClinical stage IIDe-escalate therapyHigh pCR ratePrespecified end pointPrespecified secondary analysisSecondary end pointsStandard neoadjuvant chemotherapySimilar baseline characteristicsSubset of patientsT cell infiltrationRandomized clinical trialsTumor cell proliferationWhole transcriptome RNA sequencing
2019
CALGB (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 armsMagnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer
Golshan M, Wong S, Loibl S, Huober J, O'Shaughnessy J, Rugo H, Wolmark N, McKee M, Maag D, Sullivan D, Metzger-Filho O, Von Minckwitz G, Geyer C, Sikov W, Untch M. Magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer. European Journal Of Surgical Oncology 2019, 45: e12-e13. DOI: 10.1016/j.ejso.2018.10.075.Peer-Reviewed Original ResearchTriple-negative breast cancerNeoadjuvant chemotherapyPathologic responseBreast cancerMagnetic resonanceChemotherapy
2017
Phase 3 study evaluating efficacy and safety of veliparib (V) plus carboplatin (Cb) or Cb in combination with standard neoadjuvant chemotherapy (NAC) in patients (pts) with early stage triple-negative breast cancer (TNBC).
Geyer C, O'Shaughnessy J, Untch M, Sikov W, Rugo H, McKee M, Huober J, Golshan M, Giranda V, Von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo J, Metzger Filho O, Rastogi P, Symmans W, Liu X, Loibl S. Phase 3 study evaluating efficacy and safety of veliparib (V) plus carboplatin (Cb) or Cb in combination with standard neoadjuvant chemotherapy (NAC) in patients (pts) with early stage triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2017, 35: 520-520. DOI: 10.1200/jco.2017.35.15_suppl.520.Peer-Reviewed Original ResearchTriple-negative breast cancerPathologic complete responseBreast conservation surgeryNeoadjuvant chemotherapyAdverse eventsArm APO placeboArm BArm CEarly-stage triple-negative breast cancerStage triple-negative breast cancerInvasive triple-negative breast cancerSafety of veliparibPlacebo-controlled studyPhase 3 studyStandard neoadjuvant chemotherapyNon-prespecified analysisPotent PARP inhibitorNCI-CTCAENeoadjuvant paclitaxelPo bidQ3 weeksPrimary endpointSecondary endpointsBaseline characteristicsBreast conservation after neoadjuvant chemotherapy for triple-negative breast cancer: Surgical results from an international randomized trial (BrighTNess).
Golshan M, Loibl S, Huober J, O'Shaughnessy J, Rugo H, Wolmark N, McKee M, Maag D, Sullivan D, Giranda V, Liu X, Von Minckwitz G, Geyer C, Sikov W, Untch M. Breast conservation after neoadjuvant chemotherapy for triple-negative breast cancer: Surgical results from an international randomized trial (BrighTNess). Journal Of Clinical Oncology 2017, 35: 514-514. DOI: 10.1200/jco.2017.35.15_suppl.514.Peer-Reviewed Original ResearchTriple-negative breast cancerNeoadjuvant systemic therapyBreast-conserving therapyBCT ratesBreast cancerSurgical assessmentOperable triple-negative breast cancerGermline BRCA mutation statusHigher mastectomy ratesInternational randomized trialsLarge prospective analysisBRCA mutation statusBCT eligibilityMastectomy ratesNeoadjuvant chemotherapySystemic therapyBreast conservationRandomized trialsSurgical managementSurgical resultsSurgical choicePatient's discretionProspective analysisMutation statusStage II
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
2009
Surgical Complications and the Use of Neoadjuvant Bevacizumab.
Golshan M, Garber J, Gelman R, Tung N, Smith B, Troyan S, Greenberg C, Winer E, Ryan P. Surgical Complications and the Use of Neoadjuvant Bevacizumab. Cancer Research 2009, 69: 43-43. DOI: 10.1158/0008-5472.sabcs-09-43.Peer-Reviewed Original ResearchTriple-negative breast cancerDefinitive local therapyPhase II trialPostoperative complicationsNeoadjuvant cisplatinDefinitive surgeryII trialWound breakdownLocal therapyMedian ageBreast cancerSingle-arm phase II trialArm phase II trialTwo-sided Fisher's exact testClinical stage IIDose-dense ACSafety of bevacizumabOperable breast cancerBreast cancer surgerySingle-arm trialNegative breast cancerFisher's exact testCycles cisplatinNeoadjuvant bevacizumabNeoadjuvant settingNeoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy
Ryan P, Tung N, Isakoff S, Golshan M, Richardson A, Corben A, Smith B, Gelman R, Winer E, Garber J. Neoadjuvant cisplatin and bevacizumab in triple negative breast cancer (TNBC): Safety and efficacy. Journal Of Clinical Oncology 2009, 27: 551-551. DOI: 10.1200/jco.2009.27.15_suppl.551.Peer-Reviewed Original ResearchTriple-negative breast cancerClinical partial responseClinical complete responseNeoadjuvant cisplatinNeoadjuvant therapyPulmonary embolismBreast cancerStable diseaseProgressive diseasePathological responseHearing lossWeeks x 4 cyclesTreatment of TNBCSingle-arm phase II trialArm phase II trialCycles of bevacizumabEfficacy of bevacizumabGrade 4 toxicityComplete pathological responseAddition of bevacizumabPhase II trialMetastatic breast cancerEfficacy of chemotherapyNegative breast cancerTissue-based assays