IMpassion130: Expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC).
Schneeweiss A, Rugo H, Winer E, Barrios C, Iwata H, Dieras V, Loi S, Maiya V, Bond J, Lei G, Chui S, Adams S, Emens L, Schmid P. IMpassion130: Expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC). Journal Of Clinical Oncology 2019, 37: 1068-1068. DOI: 10.1200/jco.2019.37.15_suppl.1068.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTriple-negative breast cancerTolerable safety profileCauses of withdrawalMonotherapy trialsPFS benefitSerious AEsSystemic corticosteroidsMedian FUSecondary endpointsNab-paclitaxelAdverse eventsPD-L1Peripheral neuropathyMedian timeSafety profileLonger FUSafety signalsBreast cancerSafety dataCumulative toxicityData cutAESIP3 studiesGr 3TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker.
Mayer E, Abramson V, Jankowitz R, Falkson C, Marcom P, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Perou C, Richardson A, Tung N, Barry W, Tan-Wasielewski Z, Timms K, Hartman A, Wolff A, Winer E. TBCRC 030: A randomized phase II study of preoperative cisplatin versus paclitaxel in TNBC—Evaluating the homologous recombination deficiency (HRD) biomarker. Journal Of Clinical Oncology 2019, 37: 507-507. DOI: 10.1200/jco.2019.37.15_suppl.507.Peer-Reviewed Original ResearchPhase II studyII studyPreoperative chemotherapyHRD scoreRandomized phase II studyOne-sided type I errorCo-primary objectivesNew safety signalsSimilar response ratesHomologous recombination deficiency biomarkersPreoperative cisplatinTNBC cohortPathologic responseRCB 0Evaluable specimensPredictive biomarkersAlternative chemotherapySpecific chemotherapySafety signalsArm CCT armChemotherapyStage IResponse rateBaseline tissue