At a glance
ClinicalIndex Comparison Record- ✓Female aged 18-70 years
- ✓Histologically confirmed unresectable locally advanced or metastatic TNBC (ER/PR/HER2 negative)
- ✓ER/PR/HER2 testing within 24 months prior to study initiation
- ✓No prior systemic treatment for advanced breast cancer except endocrine therapy, OR taxane-based chemotherapy in neoadjuvant/adjuvant phase with relapse/metastasis ≥12 months after treatment end
- ✕Prior treatment with immune checkpoint agonists (CD137) or inhibitors (CTLA-4, PD-1, PD-L1, LAG3)
- ✕Prior anti-VEGF targeted therapy
- ✕Uncontrolled or symptomatic brain or spinal cord metastases
- ✕Other active malignancy within 5 years (except locally cured tumors)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating PM8002, Nab-Paclitaxel, and 1 other intervention for Triple Negative Breast Cancer(TNBC). Currently recruiting, targeting 360 participants across 70 sites.
Detailed 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)
Study Details
Timeline
Interventions
PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle