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.
1Voluntary participation in this study and signing of the informed consent form (ICF).
Age ≥ 18 years.
Histologically and/or cytologically confirmed recurrent or metastatic breast cancer.
HER2-positive tumor status confirmed by the central laboratory (Positive definition: IHC 3+, or IHC 2+ with positive ISH).
Contraindications to trastuzumab, pertuzumab, and docetaxel, or deemed by the investigator as unsuitable for treatment with JSKN003.
Prior treatment with antibody-drug conjugates containing a topoisomerase I inhibitor (e.g., DS-8201, SHR-A1811, TQB-2102, etc.).
Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE 6.0 (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, peripheral neuropathy, or isolated laboratory abnormalities, which must have resolved to ≤ Grade 2).
During prior anti-HER2 therapy, left ventricular ejection fraction (LVEF) decreased to <50%, symptomatic congestive heart failure occurred, or toxicity leading to permanent treatment discontinuation was experienced.
Parallel
JSKN003
Drug6.3 mg/kg, IV, D1, Q3W
Trastuzumab
Drug8mg/kg loading dose, then 6mg/kg, IV, D1, Q3W
Pertuzumab
Drug840mg loading dose, then 420mg, IV, D1, Q3W
Docetaxel
Drug75 mg/m2, IV, D1, Q3W for minimum of 6 cycles or until intolerable toxicity\[ym1.1\]\[z1.2\] or disease progression, whichever occurs first.
Overall Response Rate (ORR)
ORR as Assessed by Investigator according to RECIST v1.1.
Progression-Free Survival (PFS)
PFS as Assessed by Investigator according to RECIST v1.1.
Disease Control Rate (DCR)
DCR as Assessed by Investigator according to RECIST v1.1.
Duration of Response (DoR)
DoR as Assessed by Investigator according to RECIST v1.1
Adverse Event (AE)
Assess the incidence of all AE and serious adverse events (SAE).
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This trial is not recruiting at the moment. You can still explore other options:
