Clinical Trial

FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

Active, Not Recruiting Phase 3
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Summary
This is a Phase III, randomized, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of FDA018-ADC compared with Investigator's Choice Chemotherapy(ICC) in participants with locally recurrent inoperable or metastatic Triple-negative Breast Cancer(TNBC) who are resistant to, or recurring during or after taxane therapy.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-24; most recent amendment 2026-01-20.
Status change: Recruiting → Active, Not Recruiting 2026-01-20
Status change: Not Yet Recruiting → Recruiting 2024-09-24
Trial Details
NCT Number NCT06519370
Lead Sponsor Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions Triple Negative Breast Cancer
Enrollment 350 participants
Start Date 2024-08-09
Primary Completion 2026-08-18 (estimated)
Study Completion 2027-06-20 (estimated)
Updated on ClinicalTrials.gov 2026-01-22