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NCT06419621

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer

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)
Biotheus Inc.·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Triple Negative Breast Cancer(TNBC)
Drug/Device/Intervention
PM8002
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Biotheus Inc.
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 3
Start date
Jun 01, 2024
End date
Jul 01, 2028
Enrollment
360 participants
Primary outcome

Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) - All Participants and Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors,Overall Survival (OS) - All Participants and Participants with PD-L1 CPS≥1 Tumors

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)

ICD-10 classifications
Other carcinoma in situ of breastMalignant neoplasm: Lower-outer quadrant of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Lower-inner quadrant of breastMalignant neoplasm: Upper-outer quadrant of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06419621
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06419621 through Pure Global AI's free database. This Phase 3 trial is sponsored by Biotheus Inc. and is currently Not yet recruiting. The study focuses on Triple Negative Breast Cancer(TNBC). Target enrollment is 360 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.