Active, not recruiting
Phase 3
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
Condition(s) studied
Triple Negative Breast Cancer(TNBC)
Investigational drug(s) / intervention(s)
PM8002Nab-PaclitaxelPlacebo
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
Study 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)
Eligibility
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- 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.
Trial sites (70)
| Facility | City | Region | Status |
| The first affiliated hospital of bengbu medical University |
Bengbu |
Anhui |
|
| The First Affiliated Hospital of Anhui Medical University |
Hefei |
Anhui |
|
| Cancer Hospital Chinese Academy of Medical Sciences |
Beijing |
Beijing Municipality |
|
| Fifth Medical Center of Chinese PLA General Hospital |
Beijing |
Beijing Municipality |
|
| Chongqing University Cancer Hospital |
Chongqing |
Chongqing Municipality |
|
| The First Affiliated Hospital of Chongqing Medical University |
Chongqing |
Chongqing Municipality |
|
| The Southwest Hospital of Army Medical University |
Chongqing |
Chongqing Municipality |
|
| Fujian Provincial Cancer Hospital |
Fuzhou |
Fujian |
|
| Lanzhou University First Hospital |
Lanzhou |
Gansu |
|
| The First People's Hospital of Foshan |
Foshan |
Guangdong |
|
| Affillated Cancer Hospital and Institute of Guangzhou Medical University |
Guangzhou |
Guangdong |
|
| Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University |
Guangzhou |
Guangdong |
|
| Sun Yat-sen University Cancer Center |
Guangzhou |
Guangdong |
|
| Yuebei People's Hospital |
Shaoguan |
Guangdong |
|
| Guangxi Medical University Cancer Hospital |
Nanning |
Guangxi |
|
| The First Affiliated Hospital of Guangxi Medical University |
Nanning |
Guangxi |
|
| Affiliated Hospital of Hebei University |
Baoding |
Hebei |
|
| The Fourth Hospital of Hebei Medical University |
Shijiazhuang |
Hebei |
|
| Harbin Medical University Cancer Hospital |
Harbin |
Heilongjiang |
|
| The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology |
Anyang |
Henan |
|
| The First Affiliated Hospital of Henan University of Science and Technology |
Luoyang |
Henan |
|
| Nanyang Central Hospital |
Nanyang |
Henan |
|
| The First Affiliated Hospital of Xinxiang Medical University |
Xinxiang |
Henan |
|
| Henan Cancer Hospital |
Zhengzhou |
Henan |
|
| The First Affiliated Hospital of Zhengzhou University |
Zhengzhou |
Henan |
|
| Hubei Cancer Hospital |
Wuhan |
Hubei |
|
| Union Hospital Tongji Medical College of Hust |
Wuhan |
Hubei |
|
| Zhongnan Hospital of Wuhan University |
Wuhan |
Hubei |
|
| The First People's Hospital of Changde City |
Changde |
Hunan |
|
| Hunan Cancer Hospital |
Changsha |
Hunan |
|
| Xiangyang Cancer Hospital |
Xiangyang |
Hunan |
|
| The Central Hospital of Yongzhou |
Yongzhou |
Hunan |
|
| Jiangsu Province Hospital |
Nanjing |
Jiangsu |
|
| The Affiliated Hospital of Nantong University |
Nantong |
Jiangsu |
|
| The Second Affiliated Hospital of Suzhou University |
Suzhou |
Jiangsu |
|
| Xuzhou Central Hospital |
Xuzhou |
Jiangsu |
|
| Northern Jiangsu People's Hospital |
Yangzhou |
Jiangsu |
|
| Jiangxi Cancer Hospital |
Nanchang |
Jiangxi |
|
| Jilin Cancer Hospital |
Changchun |
Jilin |
|
| The First Hospital of Jilin University |
Changchun |
Jilin |
|
+ 30 more sites — see the full list on the official registry below.
More Biotheus Inc. trials in China