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
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