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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Progression-free survival (PFS)
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause
Time frame: up to 24 months
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: up to 24 months
Progression-Free Survival (PFS) by Investigator assessment
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause
Time frame: up to 24 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR or PR, as determined by BICR/investigator assessment, per RECIST 1.1.
Time frame: up to 24 months
Duration of Response Duration of Response (DoR)
DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause.
Time frame: up to 24 months
Disease Control Rate (DCR)
DCR is defined as the proportion of patients who have achieved complete response,partial response and stable disease assessed by BICR/investigator according to RECIST v 1.1
Time frame: up to 24 months
Incidence of Treatment-Emergent Adverse Events
Incidence and severity of AEs and SAEs (graded by CTCAE version 5.0).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: up to 24 months
Immunogenicity of FDA018-ADC
Presence of ADAs for FDA018-ADC
Time frame: up to 24 months