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)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 392
- 试验地点
- 123
- 主要终点
- Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •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).
排除标准
- •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.
研究组 & 干预措施
Placebo Plus Nab-Paclitaxel
Patients will receive both Placebo and Nab-Paclitaxel.
干预措施: Nab-Paclitaxel (Drug)
Placebo Plus Nab-Paclitaxel
Patients will receive both Placebo and Nab-Paclitaxel.
干预措施: Placebo (Drug)
PM8002 Plus Nab-Paclitaxel
Patients will receive both PM8002 and Nab-Paclitaxel.
干预措施: PM8002 (Drug)
PM8002 Plus Nab-Paclitaxel
Patients will receive both PM8002 and Nab-Paclitaxel.
干预措施: Nab-Paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
时间窗: 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)
时间窗: 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.
次要结局
- PFS assessed by investigator(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)
- Objective response rate (ORR) 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)
- 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)
- 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)