NCT05838066RecruitingPhase 3
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With 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.
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 880 (estimated)
- First submitted
- 20 Apr 2023
- Start date
- 23 Jul 2023
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05838066
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 880
- From 23 Jul 2023 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trials Information Group Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
Related publications
- Anbenitamab plus HB1801 for HER2-Positive Advanced Breast Cancer.N Engl J Med · 2026 · PMID 42929681
This page is information, not medical advice. Discuss any trial with your doctor.