Actively Recruiting
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
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2026-04-16
364
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form voluntarily.
- Age between 18 and 75 years, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed diagnosis of triple-negative breast cancer.
- Failure of at least two prior lines of systemic chemotherapy.
- At least one measurable extracranial lesion per RECIST v1.1.
- Agreement to provide a tumor tissue specimen.
- Adequate organ and bone marrow function.
- Recovery from prior treatment-related toxicities to Grade 1 or less per NCI CTCAE v5.0.
- Assessed as suitable for treatment with eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan.
- Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to randomization and agree to contraception during the trial.
You will not qualify if you...
- Prior treatment with topoisomerase I inhibitor-based antibody-drug conjugates, except TROP2-targeted ADCs.
- Diagnosis of another malignancy within 5 years prior to randomization, except certain treated skin and thyroid cancers and carcinomas in situ.
- Presence of cerebrovascular or cardiovascular diseases or risk factors.
- Inadequate washout from prior therapies before randomization.
- Active central nervous system metastases without prior local treatment, brainstem/meninges/spinal cord metastases, or history of carcinomatous meningitis.
- Severe or uncontrolled concomitant diseases affecting safety or compliance.
- Tumor invasion of adjacent vital organs or blood vessels or risk of developing esophagotracheal or esophagopleural fistula.
- Active hepatitis B or C infection.
- Positive HIV test or history of AIDS; active syphilis or tuberculosis infection.
- History of allogeneic bone marrow or organ transplantation.
- Significant ophthalmic diseases.
- History of interstitial lung disease or non-infectious pneumonitis requiring steroid treatment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510289
Actively Recruiting
Research Team
Y
Yuan Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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