Clinical trial NCT06519370: FDA018-ADC Vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objectives of the study are to demonstrate the superiority of FDA018-ADC relative to ICC by assessment of PFS per Blinded Independent Central Review(BICR) and OS in participants with locally recurrent inoperable or metastatic TNBC who are resistant to, or recurring during or after taxane therapy.

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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 24 months
measure: Overall Survival (OS)
timeFrame: up to 24 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) by Investigator assessment
timeFrame: up to 24 months
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
measure: Duration of Response Duration of Response (DoR)
timeFrame: up to 24 months
measure: Disease Control Rate (DCR)
timeFrame: up to 24 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: up to 24 months
measure: Immunogenicity of FDA018-ADC
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jian Zhang
role: PRINCIPAL_INVESTIGATOR
References: