A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer

ConditionResectable 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

KN026
Drug
In accordance with the protocol
HB1801
Drug
In accordance with the protocol
Trastuzumab
Drug
Intravenous infusion
Pertuzumab
Drug
Intravenous infusion
Docetaxel
Drug
Intravenous infusion
Epirubicin
Drug
Intravenous infusion
Doxorubicin
Drug
Intravenous infusion
Cyclophosphamide
Drug
Intravenous infusion
Carboplatin
Drug
Intravenous infusion

Treatment groups

1,800 Participants

are divided into 2 treatment groups

Group A: KN026 combined with HB1801 and chemotherapyExperimental treatment 6 interventions

Group B: Trastuzumab combined with pertuzumab and chemotherapyActive comparator 7 interventions

Trial outcomes

Primary outcomes

iDFS

Time from randomization to the first occurrence of any of the following events: 1. Disease recurrence (local/regional/distant metastasis, contralateral breast metastasis, confirmed by histology/cytology or clinical diagnosis). 2. Death from any cause. Note: Excludes second primary malignancies other than breast cancer.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai JMT-Bio Inc.

Lead sponsor

Source ClinicalTrials.gov

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