NCT06419621

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Biotheus Inc. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Triple Negative Breast Cancer(TNBC)

Interventions

Type	Name	Description
DRUG	PM8002	PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
DRUG	Nab-Paclitaxel	Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
DRUG	Placebo	Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle

Timeline

• Start date: 2024-06-11
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2024-05-17
• Last updated: 2025-03-12

Locations

70 sites across 1 country: China