FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastat… (NCT06519370) | Clinical Trial Compass
Active — Not RecruitingPhase 3
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
China350 participantsStarted 2024-08-09
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;
✕. Have central nervous system metastasis with clinical symptoms;
✕. Have history of clinical significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months prior to the first dose;
✕. Suffering from active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease), and history of intestinal obstruction, or Gl perforation;
✕. Patients with Gilbert's disease or heterozygous for the UGT1A1\*28 allele;
✕. Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive;
✕. Patients who have received prior TROP-2-targeted therapy;
✕. Patients who have received prior topoisomerase I inhibitor contained therapy;