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 inhibitorsCancerAssociation 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 arms
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 characteristics