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
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.
• Patients capable to give written informed consent;
• Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization;
• Prior exposure to a taxane in localized or advanced/metastatic setting, and recurred during or after treatment;
• Eligible for one of the chemotherapy options listed as ICC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment;
• Have measurable lesions defined in RECIST v.1.1, those with only skin or bone lesions cannot be included;
• Expected survival≥3 months;
• Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
• Adequate bone marrow, hepatic, and renal function;
• All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 5.0≤1;
⁃ Subjects could provide tumor tissues or tissue specimens;
⁃ Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.