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ACTIVE NOT RECRUITING
NCT06519370
PHASE3

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.

View on ClinicalTrials.gov

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

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China