New treatment for HER2-positive recurrent or metastatic breast cancer
A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
This study is testing a new combination treatment for people with HER2-positive recurrent or metastatic breast cancer to see if it works better than the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 880 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai JMT-Bio Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, trastuzumab, pertuzumab |
| Locations | 1 site (Beijing, chaoyang) |
| Trial ID | NCT05838066 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a new combination treatment involving KN026 and HB1801 compared to the standard treatment of trastuzumab, pertuzumab, and docetaxel for patients with HER2-positive recurrent or metastatic breast cancer. It is a randomized, controlled, open-label, multicenter phase 3 study that aims to demonstrate the superiority of the new treatment in terms of progression-free survival. An independent data monitoring committee will oversee safety assessments and conduct interim analyses during the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed HER2-positive recurrent or metastatic breast cancer who have not received prior systemic chemotherapy or HER2-targeted therapy.
Not a fit: Patients with untreated or unstable metastases, pregnant or lactating women, or those ineligible for any study agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective first-line option for patients with HER2-positive recurrent or metastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with similar HER2-targeted therapies, indicating potential for success with this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Voluntarily enrolled in this study and signed an informed consent form (ICF). * Age ≥ 18 years. * Recurrent or metastatic breast cancer confirmed by histology and/or cytology. * Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing. * No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer. * Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1. * Presence of lesion (RECIST 1.1). * Adequate organ and bone marrow function Key Exclusion Criteria: * Ineligible for any of the agents on the study * Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis. * Pregnant or lactating women. * Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
Where this trial is running
Beijing, chaoyang
- Clinical Trials Information Group — Beijing, chaoyang, China (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Information Group Officer
- Email: ctr-contact@mail.ecspc.com
- Phone: +86-0311-69085587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.