Clinical Research Directory
Browse clinical research sites, groups, and studies.
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-08-09
Completion Date
2027-06-20
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
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.
Eribulin
1.4mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle
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
Gemcitabine
800 to 1200 mg/m\^2 will be administered IV on day 1 and Day 8 of each 21 day cycle
Vinorelbine
25 mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China