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Triple Negative Breast CancerPhase 3NCT06519370

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

A Phase 3 study testing FDA018-ADC, Eribulin and Capecitabine in people with Triple Negative Breast Cancer, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
FDA018-ADC, Eribulin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteChina
Study dates
9 Aug 2024to 20 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
FDA018-ADC, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDA018-ADCDrug

    Also called FDA018-Antibody-drug Conjugate

    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.

  • EribulinDrug

    Also called Halaven

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

  • CapecitabineDrug

    Also called Xeloda

    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

  • GemcitabineDrug

    Also called Gemzar

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

  • VinorelbineDrug

    Also called Navelbine

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

Study groups in NCT06519370
Study groupRoleWhat they receive
FDA018-ADCExperimentalSubjects 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.
Receives: Drug: FDA018-ADC
Investigator's Choice of Chemotherapy (ICC)Active comparatorParticipants 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.
Receives: Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 24 months

  2. Overall Survival (OS)

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

    Measured: up to 24 months

Secondary outcomes (6)

  1. Progression-Free Survival (PFS) by Investigator assessment

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

    Measured: up to 24 months

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who have a confirmed CR or PR, as determined by BICR/investigator assessment, per RECIST 1.1.

    Measured: up to 24 months

  3. Duration of Response Duration of Response (DoR)

    DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR/investigator assessment or death due to any cause.

    Measured: up to 24 months

  4. Disease Control Rate (DCR)

    DCR is defined as the proportion of patients who have achieved complete response，partial response and stable disease assessed by BICR/investigator according to RECIST v 1.1

    Measured: up to 24 months

  5. Incidence of Treatment-Emergent Adverse Events

    Incidence and severity of AEs and SAEs (graded by CTCAE version 5.0).

    Measured: up to 24 months

  6. Immunogenicity of FDA018-ADC

    Presence of ADAs for FDA018-ADC

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start9 Aug 2024
  3. Primary completion18 Aug 2026 (estimated)
  4. Study completion20 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06519370
Sponsor's protocol ID
F0024-301
Status last verified
Jan 2026
First submitted
18 Jul 2024
Last updated
22 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FDA018-ADC, Eribulin and Capecitabine in people with Triple Negative Breast Cancer, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06519370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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