PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
- Conditions
- Triple Negative Breast Cancer(TNBC)
- Interventions
- Registration Number
- NCT06419621
- Lead Sponsor
- Biotheus Inc.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 360
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PM8002 Plus Nab-Paclitaxel PM8002 Patients will receive both PM8002 and Nab-Paclitaxel. Placebo Plus Nab-Paclitaxel Placebo Patients will receive both Placebo and Nab-Paclitaxel. PM8002 Plus Nab-Paclitaxel Nab-Paclitaxel Patients will receive both PM8002 and Nab-Paclitaxel. Placebo Plus Nab-Paclitaxel Nab-Paclitaxel Patients will receive both Placebo and Nab-Paclitaxel.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) Up to approximately 37 months from first patient in 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.
Overall Survival (OS) Up to approximately 37 months from first patient in 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.
- Secondary Outcome Measures
Name Time Method PFS assessed by investigator Up to approximately 37 months from first patient in Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator 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.
Disease control rate (DCR) assessed by BIRC or investigators Up to approximately 37 months from first patient in DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by BIRC or investigators using RECIST v1.1
Objective response rate (ORR) assessed by BIRC or investigators Up to approximately 37 months from first patient in ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BIRC or investigators based on RECIST 1.1 is presented.
Duration of response (DoR) assessed by BIRC or investigators Up to approximately 37 months from first patient in DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.
Incidence and severity of Adverse Event (AE) according to CTCAE 5.0 Up to 30 days after last treatment An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Differences in the scores of health-related quality of life (HRQol) evaluated by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Up to 30 days after last treatment The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
Differences in the scores of health-related quality of life (HRQol) evaluated by EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR42) Up to 30 days after last treatment Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale.
Trial Locations
- 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, China
Fifth Medical Center of Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Southwest Hospital of Army Medical University
🇨🇳Chongqing, Chongqing, 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 Hospital of Jilin University
🇨🇳Changchun, Jilin, 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
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
Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Ruijin hospital of Shanghai Jiao Tong university School of Medicine
🇨🇳Shanghai, Shanghai, 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, 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
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China