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New hope for tough breast cancer: phase 3 trial launches

NCT ID NCT07533123

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called JSKN016 against standard treatments for people with advanced triple-negative breast cancer that has not responded to at least two prior therapies. The goal is to see if JSKN016 can slow cancer growth or extend survival. About 364 adults aged 18 to 75 with good daily function are being recruited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 364 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily sign the Informed Consent Form (ICF). * Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥ 3 months. * Histologically and/or cytologically confirmed diagnosis of Triple-Negative Breast Cancer (TNBC) based on pathology reports from the most recent biopsy or other pathological specimens. * Failure of at least 2 prior lines of systemic chemotherapy. * At least one measurable extracranial lesion per Response Evaluation Criteria in Solid -Tumors (RECIST) v1.1. * Agree to provide a tumor tissue specimen. * Adequate organ and bone marrow function. * Recovery from prior treatment-related toxicities to ≤ Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or as specified in the protocol for eligibility. * Assessed by the investigator as suitable to receive one of the following: eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan. * Female participants of childbearing potential must have a negative serum/urine pregnancy test within 7 days prior to randomization and agree to contraception during the trial. Exclusion Criteria: * Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC), with the exception of TROP2-targeted ADCs. * Diagnosis of another malignancy within 5 years prior to randomization, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, cervical carcinoma in situ, and other carcinomas in situ. * Presence of cerebrovascular or cardiovascular diseases or risk factors. * Inadequate washout from prior therapies prior to randomization. * Presence of active central nervous system (CNS) metastases without prior local treatment; presence of metastases or compression of the brainstem, meninges, or spinal cord; or history of carcinomatous meningitis. * Presence of severe or uncontrolled concomitant diseases that may affect safety or compliance. * Tumor invasion of adjacent vital organs or blood vessels (such as the heart, esophagus, superior vena cava, etc.) or risk of developing an esophagotracheal fistula or esophagopleural fistula. * Active hepatitis B; active hepatitis C. * Positive test for human immunodeficiency virus (HIV) or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; known active tuberculosis infection. * History of allogeneic bone marrow or organ transplantation. * History of significant ophthalmic diseases. * History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510289, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.