At a glance
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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
In Brief
A Phase 3 clinical trial evaluating FDA018-ADC, Eribulin, and 3 other interventions for Triple Negative Breast Cancer. Active but no longer recruiting, targeting 350 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
1.4mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle
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
800 to 1200 mg/m\^2 will be administered IV on day 1 and Day 8 of each 21 day cycle
25 mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle