Comparing FDA018-ADC to standard chemotherapy for advanced triple-negative breast cancer

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 study is testing a new treatment called FDA018-ADC to see if it works better than standard chemotherapy for people with advanced triple-negative breast cancer who haven't responded to other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06519370 on ClinicalTrials.gov

What this trial studies

This Phase III, randomized, open-label study evaluates the efficacy and safety of FDA018-ADC compared to Investigator's Choice Chemotherapy in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC) who have shown resistance to taxane therapy. The study aims to demonstrate the superiority of FDA018-ADC by assessing progression-free survival and overall survival through independent reviews. Participants will be treated at multiple international centers, ensuring a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed triple-negative breast cancer who have experienced recurrence during or after taxane therapy.

Not a fit: Patients with non-measurable lesions or those who have not received prior taxane therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with difficult-to-treat triple-negative breast cancer.

How similar studies have performed: Previous studies have shown promising results with similar targeted therapies in triple-negative breast cancer, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jian Zhang — Fudan University
• Study coordinator: Lihua Qing

Conditions Triple Negative Breast Cancer