A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai JMT-Bio Inc.
About this trial
This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and chemotherapy as adjuvant therapy in participants with HER2-positive breast cancer.
Eligibility criteria
Qualifiers
Voluntarily participate and sign the informed consent form.
Age ≥ 18 years.
ECOG performance status score of 0 or 1.
Histologically or cytologically confirmed invasive breast cancer.
Disqualifiers
History of any prior ipsilateral and/or contralateral invasive breast cancer.
History of other malignancy within 5 years prior to randomization, except for the breast cancer under study and locally curable malignancies treated with curative intent.
Prior systemic chemotherapy, endocrine therapy, anti-HER2 targeted therapy, or local radiotherapy for breast cancer.
Use of strong CYP3A4 inhibitors within 14 days prior to randomization or planned use during the combination chemotherapy period.
Trial design
Treatments tested in this trial
- KN026
- HB1801
- Trastuzumab
- Pertuzumab
- Docetaxel
- Epirubicin
- Doxorubicin
- Cyclophosphamide
- Carboplatin
Treatment groups
1,800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov