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.
Study ID
NCT06519370
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FDA018-ADC — DRUG
    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 — DRUG
    1.4mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle
  • Capecitabine — DRUG
    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 — DRUG
    800 to 1200 mg/m\^2 will be administered IV on day 1 and Day 8 of each 21 day cycle
  • Vinorelbine — DRUG
    25 mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

Study Details

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.

Key Dates

Start date
Aug 9, 2024
Status verified
Jan 2026
Primary completion
Aug 18, 2026
Completion
Jun 20, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: Investigator's Choice of Chemotherapy (ICC)
    Participants will receive ICC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until disease progression, unacceptable toxicity or death.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: up to 24 months ]

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