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

NCT06519370 | Active Not Recruiting Phase 3

• 1 other identifier: F0024-301
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause

  up to 24 months

• Overall Survival (OS)

  OS is defined as the time from randomisation until the date of death due to any cause.

  up to 24 months

Secondary Outcomes (6)

• Progression-Free Survival (PFS) by Investigator assessment

  up to 24 months

• Objective Response Rate (ORR)

  up to 24 months

• Duration of Response Duration of Response (DoR)

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Incidence of Treatment-Emergent Adverse Events

  up to 24 months

Study Arms (2)

FDA018-ADC

EXPERIMENTAL

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.

Drug: FDA018-ADC

Investigator's Choice of Chemotherapy (ICC)

ACTIVE COMPARATOR

Participants will receive ICC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until disease progression, unacceptable toxicity or death.

Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine

Interventions

FDA018-ADC DRUG

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.

Also known as: FDA018-Antibody-drug Conjugate

FDA018-ADC

Eribulin DRUG

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

Also known as: Halaven

Investigator's Choice of Chemotherapy (ICC)

Capecitabine DRUG

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

Also known as: Xeloda

Investigator's Choice of Chemotherapy (ICC)

Gemcitabine DRUG

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

Also known as: Gemzar

Investigator's Choice of Chemotherapy (ICC)

Vinorelbine DRUG

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

Also known as: Navelbine

Investigator's Choice of Chemotherapy (ICC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

eribulin; Capecitabine; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Jian Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 25, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)