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Clinical Trials in China / NCT06519370
Active, not recruiting Phase 3

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

NCT06519370 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2024-08-09
Last updated
2026-01-22

Condition(s) studied

Triple Negative Breast Cancer

Investigational drug(s) / intervention(s)

FDA018-ADCEribulinCapecitabineGemcitabineVinorelbine

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.

Eribulin: 1.4mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

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

Gemcitabine: 800 to 1200 mg/m\^2 will be administered IV on day 1 and Day 8 of each 21 day cycle

Vinorelbine: 25 mg/m\^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients capable to give written informed consent; 2. 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; 3. Prior exposure to a taxane in localized or advanced/metastatic setting, and recurred during or after treatment; 4. Eligible for one of the chemotherapy options listed as ICC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment; 5. Have measurable lesions defined in RECIST v.1.1, those with only skin or bone lesions cannot be included; 6. Expected survival≥3 months; 7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1; 8. Adequate bone marrow, hepatic, and renal function; 9. All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 5.0≤1; 10. Subjects could provide tumor tissues or tissue specimens; 11. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment. Exclusion Criteria: 1. 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; 2. Have central nervous system metastasis with clinical symptoms; 3. 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; 4. Suffering from active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease), and history of intestinal obstruction, or Gl perforation; 5. Patients with Gilbert's disease or heterozygous for the UGT1A1\*28 allele; 6. Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive; 7. Patients who have received prior TROP-2-targeted therapy; 8. Patients who have received prior topoisomerase I inhibitor contained therapy; 9. Received other anti-tumor treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, experimental treatment and so on) within 4 weeks prior to the first dose; 10. Patients who have received live vaccines within 4 weeks prior to the first dose; 11. Patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose; 12. Patients who had undergone systemic high-dose steroids within 2 weeks prior to the first dose; 13. Patients have history of psychotropic drug abuse, alcohol or drug abuse; 14. Women who are pregnant or lactating; 15. Other circumstances that is deemed not appropriate for the study by investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality

More Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06519370 on ClinicalTrials.gov ↗ ← All trials in China