A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line … (NCT07545044) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
60 participantsStarted 2026-05-30
Plain-language summary
This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not previously received systemic therapy for advanced disease (participants who have undergone one prior endocrine treatment regimen are eligible for enrollment). The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for participants with HER2-positive recurrent or metastatic breast cancer.
Who can participate
Age range
18 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.
. Hepatic function: Total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); alkaline phosphatase (ALP) ≤ 2.5 × ULN.
. Renal function: Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).
. Coagulation function: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. For participants receiving anticoagulant therapy, the investigator must deem both INR and APTT to be within a safe and effective therapeutic range.
. Left ventricular ejection fraction (LVEF) \> 50%.
Exclusion criteria
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.
. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia causing hemodynamic instability within 6 months prior to randomization;
. History of clinically significant QT interval prolongation, or QTcF (calculated using Fridericia's formula) \>480 ms during screening;
. Arterial/venous thrombotic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
. Active HBV or HCV infection. Participants who are HBsAg positive and/or HCV antibody positive during screening must undergo HBV DNA and/or HCV RNA testing. Only participants with HBV DNA below the upper limit of normal and/or negative HCV RNA are eligible;