JSKN016 versus physician's choice for advanced triple-negative breast cancer after prior treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III interventional trial assigns participants to receive either JSKN016 or one of several physician-selected chemotherapies (for example, eribulin, vinorelbine, capecitabine, or gemcitabine). The primary endpoint is progression-free survival as determined by a Blinded Independent Review Committee using RECIST v1.1, and overall survival is a key secondary endpoint. Eligible patients have histologically confirmed triple-negative breast cancer that is unresectable locally advanced, recurrent, or metastatic, have failed at least two prior systemic chemotherapy regimens, have ECOG performance status 0–1, and at least one measurable extracranial lesion. Participants must provide a tumor tissue specimen and have adequate organ and marrow function before starting treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yuan Huang
• Email: yuanhuang@alphamabonc.com
• Phone: 0512-62850800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.