Yardley, D AColeman, RConte, PCortes, JBrufsky, AShtivelband, MYoung, RBengala, CAli, HEakel, JSchneeweiss, Ade la Cruz-Merino, LWilks, SO'Shaughnessy, JGlück, SLi, HMiller, JBarton, DHarbeck, NtnAcity investigators2023-01-252023-01-252018http://hdl.handle.net/10668/12560Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC. Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m2 plus C AUC 2, nab-P 125 mg/m2 plus G 1000 mg/m2, or G 1000 mg/m2 plus C AUC 2, all on days 1, 8 q3w. Phase II primary end point: investigator-assessed progression-free survival (PFS); secondary end points included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety. In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38-0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37-0.90]; P = 0.02). OS was numerically longer with nab-P/C versus nab-P/G (median, 16.8 versus 12.1 months; HR, 0.73 [95% CI, 0.47-1.13]; P = 0.16) or G/C (median, 16.8 versus 12.6 months; HR, 0.80 [95% CI, 0.52-1.22]; P = 0.29). ORR was 73%, 39%, and 44%, respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic. First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile versus nab-P/G or G/C.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/AdultAgedAged, 80 and overAlbuminsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinChemotherapy, AdjuvantDeoxycytidineDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMastectomyMiddle AgedPaclitaxelProgression-Free SurvivalTriple Negative Breast NeoplasmsGemcitabineresearch article29878040open access10.1093/annonc/mdy2011569-8041PMC6096741http://www.annalsofoncology.org/article/S0923753419341225/pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6096741/pdf