New hope for tough breast cancer: phase 3 trial launches
NCT ID NCT07533123
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 364 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510289, China
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Other studies related to the condition(s) this trial covers.
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