PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
NCT ID: NCT06419621
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2024-06-11
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PM8002 Plus Nab-Paclitaxel
Patients will receive both PM8002 and Nab-Paclitaxel.
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 Plus Nab-Paclitaxel
Patients will receive both Placebo and Nab-Paclitaxel.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Female, aged 18 to 70 years (inclusive);
* Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological;
* Subjects who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and/or adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment;
* Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1;
* Life expectancy of 12 weeks or more;
* According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression).
Exclusion Criteria
* Has uncontrolled or symptomatic brain or spine cord metastases;
* Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ;
* Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
* With a history of hypertensive crisis or hypertensive encephalopathy;
* With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment;
* Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
* Has uncontrollable pleural, pericardial, or abdominal effusions;
* Has received allogeneic hematopoietic stem cell transplantation or organ transplantation.
18 Years
70 Years
FEMALE
No
Sponsors
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Biotheus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jiong Wu, professor
Role: STUDY_CHAIR
Fudan University
Jian Zhang, professor
Role: STUDY_CHAIR
Fudan University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Gongsheng Jin
Role: primary
Yingying Du
Role: primary
Peng Yuan
Role: primary
Tao Wang
Role: primary
Xiaohua Zeng
Role: primary
Lu Gan
Role: primary
Yi Zhang
Role: primary
Fan Wu
Role: primary
Xiaoling Ling
Role: primary
Qian Hu
Role: primary
Hongsheng Li
Role: primary
Ying Wang
Role: primary
Shusen Wang
Role: primary
Ruiwen Lei
Role: primary
Weimin Xie
Role: primary
Yang Li
Role: primary
Hua Yang
Role: primary
Cuizhi Geng
Role: primary
Qingyuan Zhang
Role: primary
Junlan Guo
Role: primary
Xinshuai Wang
Role: primary
Hao Zhang
Role: primary
Yinghua Ji
Role: primary
Min Yan
Role: primary
Hong Zong
Role: primary
Xinhong Wu
Role: primary
Jing Yao
Role: primary
Haijun Yu
Role: primary
Tao Wu
Role: primary
Quchang Ouyang
Role: primary
Yuehua Wang
Role: primary
Sijuan Ding
Role: primary
Yongmei Yin
Role: primary
Sujie Ni
Role: primary
Zhixiang Zhuang
Role: primary
Yanhua Liu
Role: primary
Deyuan Fu
Role: primary
Zhengkui Sun
Role: primary
Chunjiao Wu
Role: primary
Yanqing Cao
Role: primary
Xuening Ji
Role: primary
Man Li
Role: primary
Jianyi Li
Role: primary
Caigang Liu
Role: primary
Yuee Teng
Role: primary
Jin Yang
Role: primary
Shuqun Zhang
Role: primary
Huihui Li
Role: primary
Zhongsheng Xia
Role: primary
Jingfen Wang
Role: primary
Haibo Wang
Role: primary
Wenhui Wang
Role: primary
Jian Zhang
Role: primary
Kejin Wu
Role: primary
Kunwei Shen
Role: primary
Fuguo Tian
Role: primary
Xiaoke Hou
Role: primary
Junjie Li
Role: primary
Jing Luo
Role: primary
Xiaobo Du
Role: primary
Xin Hu
Role: primary
Shubin Tang
Role: primary
Xujiang Wang
Role: primary
Hongwei Yang
Role: primary
Zhongsheng Tong
Role: primary
Jianyun Nie
Role: primary
Yiding Chen
Role: primary
Hai Hu
Role: primary
Bojian Xie
Role: primary
Zhenchen Wang
Role: primary
Other Identifiers
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PM8002-C013C-TNBC-R
Identifier Type: -
Identifier Source: org_study_id
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