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

A Randomized, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy

This trial will test whether JSKN016 works better than a physician's choice chemotherapy for adults with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer who have already had at least two prior systemic chemotherapies.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 364 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (industry)
• Drugs / interventions: sacituzumab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07533123 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer who have failed at least two prior systemic chemotherapy regimens, have ECOG 0–1, and at least one measurable extracranial lesion are ideal candidates.

Not a fit: Patients with early-stage disease, those who have not exhausted at least two prior lines of systemic chemotherapy, those with poor organ function or ECOG >1, or those unable to provide a tumor specimen are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, JSKN016 could extend the time patients live without their disease getting worse and possibly improve overall survival compared with current chemotherapy options.

How similar studies have performed: Related drug classes such as antibody–drug conjugates and newer chemotherapies have shown benefit in some TNBC settings, but JSKN016 itself is novel and unproven in a Phase III setting.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Yuan Huang

Conditions: Triple Negative Breast Cancer