Actively Recruiting
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
Led by Biotheus Inc. · Updated on 2025-03-12
360
Participants Needed
70
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures
- 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, with testing within 24 months prior to study start
- No prior systemic treatment for advanced breast cancer except endocrine therapy; prior Taxane-based chemotherapy in neoadjuvant/adjuvant setting allowed if relapse/metastasis occurred at least 12 months after treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of 12 weeks or more
- At least one measurable lesion per RECIST 1.1, excluding only bone or central nervous system metastases and certain previously treated lesions
You will not qualify if you...
- Previous treatment with immune checkpoint agonists or inhibitors or anti-vascular endothelial growth factor (VEGF) target drugs
- Uncontrolled or symptomatic brain or spinal cord metastases
- Other active malignant tumors within 5 years prior to study except locally treated and cured
- Poorly controlled hypertension (systolic 202140 mmHg and/or diastolic 202190 mmHg)
- History of hypertensive crisis or hypertensive encephalopathy
- History of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study
- Unresolved adverse events from prior anti-tumor therapies above Grade 1 per CTCAE 5.0
- Uncontrollable pleural, pericardial, or abdominal effusions
- Received allogeneic hematopoietic stem cell or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 70 locations
1
The first affiliated hospital of bengbu medical University
Bengbu, Anhui, China
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
3
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
4
Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
5
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
7
The Southwest Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
8
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
9
Lanzhou University First Hospital
Lanzhou, Gansu, China
Actively Recruiting
10
The First People's Hospital of Foshan
Foshan, Guangdong, China
Actively Recruiting
11
Affillated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
12
Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
13
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
14
Yuebei People's Hospital
Shaoguan, Guangdong, China
Actively Recruiting
15
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
16
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
17
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Actively Recruiting
18
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
19
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
20
The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology
Anyang, Henan, China
Actively Recruiting
21
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Actively Recruiting
22
Nanyang Central Hospital
Nanyang, Henan, China
Actively Recruiting
23
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Actively Recruiting
24
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
25
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
26
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
27
Union Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Actively Recruiting
28
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
29
The First People's Hospital of Changde City
Changde, Hunan, China
Actively Recruiting
30
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
31
Xiangyang Cancer Hospital
Xiangyang, Hunan, China
Actively Recruiting
32
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Actively Recruiting
33
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
34
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Actively Recruiting
35
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Actively Recruiting
36
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
37
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Actively Recruiting
38
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
39
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
40
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
41
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Actively Recruiting
42
The Second Hospital Of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
43
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Actively Recruiting
44
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
45
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
46
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Actively Recruiting
47
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Actively Recruiting
48
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
49
Affiliated hospital of Jining Medical University
Jining, Shandong, China
Actively Recruiting
50
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
51
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
52
Weifang People's Hospital
Weifang, Shandong, China
Actively Recruiting
53
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
54
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
55
Ruijin hospital of Shanghai Jiao Tong university School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
56
Shanxi cancer hospital
Taiyuan, Shanxi, China
Actively Recruiting
57
Runcheng City Center Hospital
Yuncheng, Shanxi, China
Actively Recruiting
58
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
59
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
60
Mianyang Central Hospital
Mianyang, Sichuan, China
Actively Recruiting
61
Nanchong Central Hospital of Sichuan Province
Nanchong, Sichuan, China
Actively Recruiting
62
The First People's Hospital of Neijiang
Neijiang, Sichuan, China
Actively Recruiting
63
The Second People's Hospital Of Neijiang
Neijiang, Sichuan, China
Actively Recruiting
64
Suining Central Hospital
Suining, Sichuan, China
Actively Recruiting
65
Tian Jin Medicial University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
66
Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)
Kunming, Yunnan, China
Actively Recruiting
67
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
68
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
69
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
70
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yanqing Cao
CONTACT
L
Linlin Fan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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