PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

Biotheus

Status and phase: Enrolling; Phase 3

Conditions: Triple Negative Breast Cancer(TNBC)

Treatments: Drug: Nab-Paclitaxel; Drug: PM8002; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06419621

PM8002-C013C-TNBC-R

Details and patient eligibility

About

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)

Enrollment: 360 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

PM8002 Plus Nab-Paclitaxel

Experimental group

Description:

Patients will receive both PM8002 and Nab-Paclitaxel.

Treatment:

Drug: PM8002

Drug: Nab-Paclitaxel

Placebo Plus Nab-Paclitaxel

Placebo Comparator group

Description:

Patients will receive both Placebo and Nab-Paclitaxel.

Treatment:

Drug: Placebo

Drug: Nab-Paclitaxel