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

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 and Xichun Hu ()
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Biyun Wang: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University
Tao Sun: Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Yannan Zhao: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University
Shusen Wang: Sun Yat-Sen University Cancer Center, The State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine
Jian Zhang: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University
Zhonghua Wang: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University
Yue-E Teng: The First Hospital of China Medical University
Li Cai: Harbin Medical University Cancer Hospital
Min Yan: Henan Breast Cancer Center, The affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Xiaojia Wang: Zhejiang Cancer Hospital
Zefei Jiang: The Fifth Medical Center of Chinese PLA General Hospital
Yueyin Pan: The First Hospital, Anhui Medical University
Jianfeng Luo: Fudan University
Zhimin Shao: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University
Jiong Wu: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University
Xiaomao Guo: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University
Xichun Hu: Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University

Nature Communications, 2022, vol. 13, issue 1, 1-7

Abstract: Abstract Platinum is recommended in combination with gemcitabine in 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) with gemcitabine/cisplatin (GP) in mTNBC patients (ClinicalTrials.gov NCT02546934). 254 patients with untreated mTNBC randomly receive AP (nab-paclitaxel 125 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) or GP (gemcitabine 1250 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) intravenously every 3 weeks until progression disease, intolerable toxicity or withdrawal of consent. The primary endpoint is progression-free survival (PFS); secondary endpoints are objective response rate (ORR), safety and overall survival (OS). The trial has met pre-specified endpoints. The median PFS is 9.8 months with AP as compared to 7.4 months with GP (stratified HR, 0.67; 95% CI, 0.50–0.88; P = 0.004). AP significantly increases ORR (81.1% vs. 56.3%, P

Date: 2022
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DOI: 10.1038/s41467-022-31704-7

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