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QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial

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收录情况： ◇ SCIE

作者：
Zuo Wenjia[1] * ; Wang Zhonghua[1] * ; Qian Jun[2] ; Ma Xiaopeng[3] ; Niu Zhaofeng[4] ; Ou Jianghua[5] ; Mo Qinguo[6] ; Sun Jing[7] ; Li Xinzheng[8] ; Wang Qitang[9] ; Yao Yongzhong[10] ; Yu Guohua[11] ; Li Hongsheng[12] ; Chen Dedian[13] ; Zhang Hao[14] ; Geng Cuizhi[15] ; Qiao Guangdong[16] ; Zhao Mengmeng[17] ; Zhang Baihui[17] ; Kang Xiaoyan[17] ; Zhang Jin[18] ; Shao Zhimin[19] ;
机构： [1]Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China. [2]Department of Surgical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, 233099, China. [3]Department of General Surgery, The First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, 230001, China. [4]Department of Breast Disease, Yuncheng Central Hospital, Yuncheng, 044099, China. [5]Department of Breast Surgery, Cancer Hospital Affiliated to Xinjiang Medical University, Urumqi, 830000, China. [6]Department of Breast Surgery, Guangxi Medical University Cancer Hospital, Nanning, 530021, China. [7]The Fifth Department of Internal Medicine, Anyang Tumor Hospital, Anyang, 455000, China. [8]Department of Breast Surgery, Shanxi Cancer Hospital, Xi'an, 710061, China. [9]Breast Medical Center, Qingdao Central Hospital, Qingdao, 266042, China. [10]Department of Breast Surgery, Department of General Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, China. [11]Department of Oncology, Weifang People's Hospital, Weifang, 261071, China. [12]Department of Breast Surgery, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, 511436, Guangzhou, China. [13]The Second Department of Breast surgery, Yunnan Cancer Hospital, Kunming, 650118, China. [14]Department of Breast Surgery, Nanyang Central Hospital, Nanyang, 473005, China. [15]Breast Center, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China. [16]Department of Breast Surgery, Yantai Yuhuangding Hospital, Yantai, 264099, China. [17]Clinical Research Center, Qilu Pharmaceutical Co., Ltd, Jinan, 250105, China. [18]The Third Department of Breast Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China. [19]Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
出处：
DOI： 10.1038/s41416-024-02751-2
ISSN：

摘要：
This randomized, parallel-controlled, double-blinded, phase III equivalence study evaluated the equivalence of a proposed pertuzumab biosimilar QL1209 to the pertuzumab (Perjeta®) each with trastuzumab and docetaxel in neoadjuvant treatment of early or locally advanced breast cancer patients with HER2-positive, ER/PR-negative.Eligible patients were randomly (1:1) assigned to receive 4 cycles of neoadjuvant QL1209 or pertuzumab each with trastuzumab and docetaxel, and adjuvant treatment. The primary endpoint was total pathologic complete response (tpCR), with equivalence margins of 0.76 to 1.32.Among the 585 patients enrolled, 257 and 259 patients were assigned to the QL1209 and pertuzumab groups, respectively. The tpCR rates were comparable in the QL1209 (109/255, 42.75%; 90% CI 37.65 to 47.84) and pertuzumab (117/259, 45.17%; 90% CI 40.09 to 50.26) groups. The tpCR risk ratio was 0.95 (90% CI, 0.80 to 1.11), and the 90% CI fell within the predefined equivalence margin. The most common grade ≥3 treatment-related adverse event was decreased neutrophil count (10. 9% vs. 12.7%) in the QL1209 and pertuzumab groups.QL1209 demonstrated equivalent efficacy and comparable safety profile to the reference pertuzumab in neoadjuvant treatment of HER2-positive, ER/PR-negative, early, or locally advanced breast cancer.Chinadrugtrials.org CTR20201073; ClinicalTrials.gov NCT04629846.© 2024. The Author(s).

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大类 | 2 区 医学
小类 | 2 区 肿瘤学
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大类 | 2 区 医学
小类 | 2 区 肿瘤学
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无
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, 200032, China.
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推荐引用方式(GB/T 7714)：
Zuo Wenjia,Wang Zhonghua,Qian Jun,et al.QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial[J].British Journal Of Cancer.2024,131(4):668-675.doi:10.1038/s41416-024-02751-2.
APA：
Zuo Wenjia,Wang Zhonghua,Qian Jun,Ma Xiaopeng,Niu Zhaofeng...&Shao Zhimin.(2024).QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial.British Journal Of Cancer,131,(4)
MLA：
Zuo Wenjia,et al."QL1209 (pertuzumab biosimilar) versus reference pertuzumab plus trastuzumab and docetaxel in neoadjuvant treatment for HER2-positive, ER/PR-negative, early or locally advanced breast cancer: A multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial".British Journal Of Cancer 131..4(2024):668-675

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