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

NCT06419621 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-03-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biotheus Inc.

    lead INDUSTRY

Principal Investigators

  • Jiong Wu, professor · Fudan University

  • Jian Zhang, professor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2027-07-31
Completion
2028-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419621 on ClinicalTrials.gov