Status:
RECRUITING
FDA018-ADC Vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
Lead Sponsor:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions:
Triple Negative Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 participan...
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 local...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Received other anti-tumor treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, experimental treatment and so on) within 4 weeks prior to the first dose;
- Patients who have received live vaccines within 4 weeks prior to the first dose;
- Patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
- Patients who had undergone systemic high-dose steroids within 2 weeks prior to the first dose;
- Patients have history of psychotropic drug abuse, alcohol or drug abuse;
- Women who are pregnant or lactating;
- Other circumstances that is deemed not appropriate for the study by investigator.
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06519370
Start Date
August 9 2024
End Date
June 20 2027
Last Update
September 26 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000