pm8002 or placebo plus nab-paclitaxel as first-line treatment in inoperable locally advanced/metastatic tnbc

Conditions: Triple Negative Breast Cancer(TNBC)

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 criteria:
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.