PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
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)
1 other identifier
interventional
360
1 country
70
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2024
Typical duration for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedStudy Start
First participant enrolled
June 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
March 12, 2025
March 1, 2025
3.1 years
May 14, 2024
March 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Up to approximately 37 months from first patient in
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.
Up to approximately 37 months from first patient in
Secondary Outcomes (7)
PFS assessed by investigator
Up to approximately 37 months from first patient in
Objective response rate (ORR) assessed by BIRC or investigators
Up to approximately 37 months from first patient in
Disease control rate (DCR) assessed by BIRC or investigators
Up to approximately 37 months from first patient in
Duration of response (DoR) assessed by BIRC or investigators
Up to approximately 37 months from first patient in
Incidence and severity of Adverse Event (AE) according to CTCAE 5.0
Up to 30 days after last treatment
- +2 more secondary outcomes
Study Arms (2)
PM8002 Plus Nab-Paclitaxel
EXPERIMENTALPatients will receive both PM8002 and Nab-Paclitaxel.
Placebo Plus Nab-Paclitaxel
PLACEBO COMPARATORPatients will receive both Placebo and Nab-Paclitaxel.
Interventions
PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle
Eligibility Criteria
You may qualify if:
- 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. 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).
You may not qualify if:
- Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotheus Inc.lead
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jiong Wu, professor
Fudan University
- STUDY CHAIR
Jian Zhang, professor
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 17, 2024
Study Start
June 11, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After the trial completed
- Access Criteria
- NCI is committed to sharing data in accordance with NIH policy
The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.