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Clinical Trial Signal transduction and targeted therapy. 2025 Feb 17;10(1):56. doi: 10.1038/s41392-025-02149-3 Q140.82024

ACE-Breast-02: a randomized phase III trial of ARX788 versus lapatinib plus capecitabine for HER2-positive advanced breast cancer

ACE-Breast-02:ARX788与拉帕替尼联合卡培他滨治疗HER2阳性晚期乳腺癌的随机III期试验 翻译改进

Xichun Hu  1, Qingyuan Zhang  2, Leiping Wang  3, Jian Zhang  3, Quchang Ouyang  4, Xiaojia Wang  5, Wei Li  6, Weimin Xie  7, Zhongsheng Tong  8, Shusen Wang  9, Faliang Xu  10, Tao Sun  11, Wei Liu  12, Zhendong Chen  13, Jinsheng Wu  14, Ying Wang  15, Haixia Wang  16, Min Yan  17, Xinshuai Wang  18, Jingfen Wang  19, Feilin Cao  20, Yingying Du  21, Yongqiang Zhang  22, Lilin Chen  23, Ping Lu  24, Sanyuan Sun  25, Ruiwen Zhang  26, Aimin Zang  27, Xiuqing Nie  28, Yuan Lei  28

作者单位 +展开

作者单位

  • 1 Fudan University Cancer Hospital, Shanghai, 200032, China. huxichun@shca.org.cn.
  • 2 Harbin Medical University Cancer Hospital, Harbin, 150081, China.
  • 3 Fudan University Cancer Hospital, Shanghai, 200032, China.
  • 4 Hunan Cancer Hospital, Changsha, 410013, China.
  • 5 Zhejiang Cancer Hospital, Hangzhou, 310022, China.
  • 6 The First Hospital of Jilin University, Changchun, 130031, China.
  • 7 Guangxi Medical University Affiliated Tumor Hospital, Nanning, 530012, China.
  • 8 Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China.
  • 9 Sun Yat-sen University Cancer Center, Guangzhou, 510060, China.
  • 10 Chongqing University Cancer Hospital, Chongqing, China.
  • 11 Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, 110122, China.
  • 12 The Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.
  • 13 The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
  • 14 The First Affiliated Hospital of Hainan Medical University, Haikou, China.
  • 15 Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • 16 Hainan General Hospital, Haikou, China.
  • 17 The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
  • 18 The First Affiliated Hospital, College of Clinical Medicine, Medical College of Henan University of Science and Technology, Luoyang, China.
  • 19 Linyi Cancer Hospital, Linyi, China.
  • 20 Taizhou Hospital, Wenzhou Medical University, Taizhou, China.
  • 21 The First Affiliated Hospital of Anhui Medical University, Hefei, China.
  • 22 Beijing Hospital, Beijing, China.
  • 23 First Affiliated Hospital of Xiamen University, Xiamen, China.
  • 24 The First Affiliated Hospital of Xinxiang Medical College, Xinxiang, China.
  • 25 Xuzhou Central Hospital, Xuzhou, China.
  • 26 Sanmenxia Central Hospital, Sanmenxia, China.
  • 27 Affiliated Hospital of Hebei University, Baoding, China.
  • 28 NovoCodex Biopharmaceuticals, Shaoxing, China.
  • DOI: 10.1038/s41392-025-02149-3 PMID: 39956849

    摘要 Ai翻译

    This phase III trial aimed to compare ARX788, a site-specific, construct-homogeneous antibody-drug conjugate, with lapatinib plus capecitabine in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC) who had progressed on one line of trastuzumab based regimen. Eligible patients were randomized (1:1) to receive ARX788 (1.5 mg/kg, IV, Q3W) or lapatinib plus capecitabine (LC: lapatinib 1250 mg QD; capecitabine 1000 mg/m2 BID, days 1-14, Q3W) and stratified by prior chemotherapy lines (0-1 versus >1) and visceral metastasis (yes versus no). The primary outcome was progression-free survival (PFS) assessed by a blinded independent central review (BICR). A total of 441 patients were randomly assigned to receive either ARX788 (n = 221) or LC (n = 220). The median PFS was 11.3 (95% confidence interval [CI], 8.4-13.8) months with ARX788 compared with 8.2 (95% CI, 6.9-8.7) months with LC, as per BICR (hazard ratio [HR] 0.64, p = 0.0006). Frequencies of treatment-related adverse events (TRAEs) of any grade were 98.6% and 99.1% for ARX788 and LC, respectively. Grade ≥3 TRAEs were 41.4% and 40.0%, respectively, the most common adverse events were blurred vision (12.3%), dry eye (9.1%), keratopathy (5.9%), and interstitial lung disease (ILD, 5.9%) with ARX788; hand-foot syndrome (18.1%) and hypokalemia (5.1%) with LC; all the hematological and gastrointestinal events of grade ≥3 with ARX788 were less than 3%. Six treatment-related deaths occurred, with three cases possibly related to ILD. ARX788 significantly improved PFS compared with LC in patients with HER2-positive ABC with a distinct toxicity profile, supporting it as a potential treatment option.

    Keywords:randomized phase III trial; lapatinib plus capecitabine

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    期刊名:Signal transduction and targeted therapy

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    ISSN:2095-9907

    e-ISSN:2059-3635

    IF/分区:40.8/Q1

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    ACE-Breast-02: a randomized phase III trial of ARX788 versus lapatinib plus capecitabine for HER2-positive advanced breast cancer