A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer

• DOI: 10.1038/s41467-022-31704-7
• Publication Date: 2022-07-12T09:16:22Z
• Authors: Biyun Wang; Tao Sun; Yannan Zhao; Shusen Wang; Jian Zhang; Zhonghua Wang; Yue-E Teng; Li Cai; Min Yan; Xiaojia Wang; Zefei Jiang; Yueyin Pan; Jianfeng Luo; Zhimin Shao; Jiong Wu; Xiaomao Guo; Xichun Hu
• Keywords: Clinical endpoint; Triple-negative breast cancer

Abstract Platinum is recommended in combination with gemcitabine the treatment of metastatic triple-negative breast cancer (mTNBC). We conduct a randomized phase 3, controlled, open-label trial to compare nab-paclitaxel/cisplatin (AP) gemcitabine/cisplatin (GP) mTNBC patients (ClinicalTrials.gov NCT02546934). 254 untreated randomly receive AP (nab-paclitaxel 125 mg/m² on day 1, 8 and cisplatin 75 1) or GP (gemcitabine 1250 intravenously every 3 weeks until progression disease, intolerable toxicity withdrawal consent. The primary endpoint progression-free survival (PFS); secondary endpoints are objective response rate (ORR), safety overall (OS). has met pre-specified endpoints. median PFS 9.8 months as compared 7.4 (stratified HR, 0.67; 95% CI, 0.50–0.88; P = 0.004). significantly increases ORR (81.1% vs . 56.3%, < 0.001) prolongs OS 0.62; 0.44–0.90; 0.010) GP. Of grade 4 adverse events, higher incidence neuropathy thrombocytopenia noted. These findings warrant further assessment adding novel agents nab-paclitaxel/platinum backbone due its high potency for mTNBC.