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

PHASE3RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

August 9, 2024

Primary Completion Date

August 18, 2026

Study Completion Date

June 20, 2027

Conditions
Triple Negative Breast Cancer
Interventions
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

Trial Locations (1)

200000

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY