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PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
Sponsor: Biotheus Inc.
Summary
This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)
Official title: A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC)
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2024-06-11
Completion Date
2028-07
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
PM8002
PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
Nab-Paclitaxel
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
Placebo
Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle
Locations (70)
The first affiliated hospital of bengbu medical University
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Southwest Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Affillated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangyang Cancer Hospital
Xiangyang, Hunan, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
The Second Hospital Of Dalian Medical University
Dalian, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Affiliated hospital of Jining Medical University
Jining, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Ruijin hospital of Shanghai Jiao Tong university School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi cancer hospital
Taiyuan, Shanxi, China
Runcheng City Center Hospital
Yuncheng, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Nanchong Central Hospital of Sichuan Province
Nanchong, Sichuan, China
The First People's Hospital of Neijiang
Neijiang, Sichuan, China
The Second People's Hospital Of Neijiang
Neijiang, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Tian Jin Medicial University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China