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Compares treatment options for Triple Negative Breast Cancer
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
ClinicalTrials.gov ID: NCT07533123
What this study is testing
What is JSKN016 Injection?
JSKN016 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Presence of severe or uncontrolled concomitant diseases that may affect safety or compliance.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.