NCT06519370

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

A Phase 3, Open-label, Randomised Study of FDA018-ADC Versus Investigator's Choice of Chemotherapy in Patients Who Recurred During or After Taxane Therapy in Locally Advanced or Metastatic Triple-negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives of the study are to demonstrate the superiority of FDA018-ADC relative to ICC by assessment of PFS per Blinded Independent Central Review(BICR) and OS in participants with locally recurrent inoperable or metastatic TNBC who are resistant to, or recurring during or after taxane therapy.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	FDA018-ADC	Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous(IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death.
DRUG	Eribulin	1.4mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle
DRUG	Capecitabine	1000 to 1250 mg/m\^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest
DRUG	Gemcitabine	800 to 1200 mg/m\^2 will be administered IV on day 1 and Day 8 of each 21 day cycle
DRUG	Vinorelbine	25 mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

Timeline

• Start date: 2024-08-09
• Primary completion: 2026-08-18
• Completion: 2027-06-20
• First posted: 2024-07-25
• Last updated: 2026-01-22

Locations

1 site across 1 country: China