A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negat… (NCT07533123) | Clinical Trial Compass
RecruitingPhase 3
A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
China364 participantsStarted 2026-03-17
Plain-language summary
Primary Endpoint of this Study:
To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \[BIRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC).
To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ba…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PFS (Progression-Free Survival)
Timeframe: From randomization to date of first documented progression or date of death from any cause. Up to approximately 3 years after the first enrollment.
2
OS (Overall Survival)
Timeframe: From randomization to date of death from any cause.Up to approximately 3 years after the first enrollment.