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Efficacy and safety of inetetamab plus pertuzumab and nab-paclitaxel as neoadjuvant therapy for HER2+ breast cancer: A single-arm multicenter phase II clinical trial

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机构: [1]Department of Breast Surgery, Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China [2]Department of Breast Surgery, The Affiliated Tumor Hospital of Guizhou Medical University, Guiyang, China [3]The First Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, China [4]Department of Breast Surgery, Deyang People’s Hospital, Deyang, Sichuan, China [5]Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, China [6]Department of Surgical Oncology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China [7]Department of Breast and Thyroid Surgery, Suining Central Hospital, Suining, Sichuan, China [8]Department of Palliative Care, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of Science and Technology, Anyang, Henan, China [9]The Breast Cancer Center, Chongqing University Cancer Hospital, Chongqing, China [10]Department of Breast Surgery, Nanyang Central Hospital, Nanyang, Henan, China [11]Department of Breast Surgery, Zhengzhou University Affiliated Oncology Hospital, Henan Provincial Cancer Hospital, Zhengzhou City, Henan, China [12]Department of Breast Surgery, First Hospital of Jilin University, Changchun, Jilin, China [13]Department of Breast Surgery, Sichuan Cancer Hospital, Chengdu, Sichuan, China [14]Department of Thyroid and Breast Surgery, The First Affiliated Hospital of University of Science and Technology of China Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China [15]The First Affiliated Hospital of Wannan Medical College, WuHu, JiangXi, China [16]Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China
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关键词: Inetetamab Neoadjuvant therapy HER2+ breast cancer tpCR

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The combination of inetetamab and vinorelbine has demonstrated survival benefits with an acceptable toxicity profile in HER2+ metastatic breast cancer (MBC) patients. This multicenter, single-arm, phase II trial further evaluates the efficacy of inetetamab combined with pertuzumab and nab-paclitaxel as neoadjuvant therapy. Treatment-naïve patients with HER2+ early-stage or locally advanced BC received four cycles of intravenous inetetamab (8 mg/kg loading dose, then 6 mg/kg for subsequent doses), intravenous pertuzumab (840 mg loading dose, then 420 mg for subsequent doses), and weekly nab-paclitaxel (125 mg/m2). The primary endpoint was the total pathological complete response (tpCR) rate, defined as ypT0/is and ypN0, assessed by independent central review. From March 2023 to February 2024, 62 patients were enrolled, with the majority (61/62) completing 4 cycles of neoadjuvant therapy. The tpCR rate was 56.5% (95% CI: 43.3%-69.0%). Further analysis showed that patients with estrogen receptor (ER) negative tumors derived greater benefit, with a tpCR rate of 90.9%. The objective response rate was 90.3% (95% CI: 80.1%-96.4%). The most common grade 3 or higher adverse events were neutropenia (32.3%), decreased white blood cell count (19.4%), infectious pneumonia (3.2%), anemia (3.2%), and diarrhea (3.2%). No death occurred during the neoadjuvant treatment. Neoadjuvant treatment with inetetamab, in combination with pertuzumab and nab-paclitaxel, demonstrates good efficacy and tolerability, especially in ER-negative patients.Copyright © 2025. Published by Elsevier B.V.

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大类 | 1 区 医学
小类 | 2 区 肿瘤学
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大类 | 1 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY
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Q1 ONCOLOGY

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第一作者机构: [1]Department of Breast Surgery, Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
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