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

ACTIVE_NOT_RECRUITINGPHASE3

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

NCT06519370•Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

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;
+5 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 9, 2024

Primary Completion Date

August 18, 2026

Completion Date

June 20, 2027

Last Updated

January 22, 2026

Enrollment

350

ESTIMATED participants

Conditions

Triple Negative Breast Cancer

Interventions

FDA018-ADC

DRUG

Eribulin

DRUG

Capecitabine

DRUG

Gemcitabine

DRUG

Vinorelbine

DRUG

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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RECRUITINGPHASE1/PHASE2

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

NCT06134375

Triple Negative Breast CancerResidual Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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