A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of KN026 Combined With HB1801 and Chemotherapy Versus Trastuzumab Combined With Pertuzumab and Chemotherapy as Adjuvant Therapy in Resectable HER2-positive Breast Cancer

Plain English Summary

A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer is a Phase 3 clinical trial sponsored by Shanghai JMT-Bio Inc. studying Resectable HER2-positive Breast Cancer. Tests KN026 and HB1801 combined with chemotherapy vs. trastuzumab and pertuzumab for HER2-positive breast cancer. For patients with resectable HER2-positive breast cancer who have undergone surgery and have positive lymph nodes. Participation involves taking study drugs and undergoing regular check-ups. Alternative treatments include trastuzumab and pertuzumab with chemotherapy. The trial aims to enroll 1800 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Ages 18 and older, good overall health, confirmed HER2-positive breast cancer, and adequate organ function. Cannot have had prior breast cancer, other cancers, or certain medical conditions, and must not be pregnant or breastfeeding. This trial is studying Resectable HER2-positive Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the 5-year disease-free survival, helping patients understand the long-term benefits. The specific primary outcome measures are: iDFS (5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial fills a gap by comparing new treatments to standard care for HER2-positive breast cancer. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Resectable HER2-positive Breast Cancer, where improved treatment options are needed.

Investor Insight

Market size is large, with strong competition but potential for approval and market share growth. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1800 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about your eligibility and the potential benefits and risks. Participation involves regular clinic visits and taking study drugs. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 1,800 participants

Interventions

• DRUG: KN026 — In accordance with the protocol
• DRUG: HB1801 — In accordance with the protocol
• DRUG: Trastuzumab — Intravenous infusion
• DRUG: Pertuzumab — Intravenous infusion
• DRUG: Docetaxel — Intravenous infusion

Primary Outcomes

• iDFS (5 years)

Full Eligibility Criteria

Inclusion Criteria:

1. Voluntarily participate and sign the informed consent form.
2. Age ≥ 18 years.
3. ECOG performance status score of 0 or 1.
4. Histologically or cytologically confirmed invasive breast cancer.
5. Must have undergone prior radical mastectomy or breast-conserving surgery for breast cancer.
6. Pathologically confirmed positive regional lymph nodes.
7. Tumor tissue confirmed as HER2-positive by the local laboratory.
8. Adequate organ and bone marrow function:

   1. Absolute neutrophil count ≥ 1.5 × 10⁹/L
   2. Platelet count ≥ 100 × 10⁹/L
   3. Hemoglobin ≥ 90 g/L
   4. Liver function: Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN
   5. Coagulation function: INR ≤ 1.5 × ULN and aPTT ≤ 1.5 × ULN
   6. Renal function: Creatinine clearance ≥ 50 mL/min
   7. LVEF ≥ 55%
9. Female participants of childbearing potential must have a negative blood pregnancy test result within 7 days prior to randomization, and agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for 7 months after the last dose of study treatment.

Exclusion Criteria:

1. History of any prior ipsilateral and/or contralateral invasive breast cancer.
2. 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.
3. Prior systemic chemotherapy, endocrine therapy, anti-HER2 targeted therapy, or local radiotherapy for breast cancer.
4. Use of strong CYP3A4 inhibitors within 14 days prior to randomization or planned use during the combination chemotherapy period.
5. Known contraindication to any study drug or history of hypersensitivity to any component or known excipient of the study drugs.
6. Significant cardiovascular disease history, including: prior coronary artery bypass graft or coronary stenting; myocardial infarction or cerebrovascular accident within 6 months prior to randomization; history of congestive heart failure/systolic dysfunction (LVEF \< 50%) or unstable angina; history of clinically significant prolonged QT interval or QTcF (Fridericia) \> 450 ms at screening; uncontrolled severe hypertension (systolic BP \> 180 mmHg and/or diastolic BP \> 100 mmHg); high-risk arrhythmias \[e.g., atrial tachycardia with resting heart rate ≥ 100 bpm, significant ventricular arrhythmia (ventricular tachycardia), or high-grade atrioventricular block (Mobitz type II second-degree or third-degree AV block)\].
7. Severe chronic or active infection requiring intravenous anti-infective therapy within 14 days prior to randomization.
8. Participation in another interventional clinical trial within 4 weeks prior to randomization.
9. Pregnant or lactating women.
10. Any other condition that may interfere with the participant's ability to comply with study procedures, may not be in the participant's best interest to participate, or may affect study results (e.g., history of neurological or psychiatric disorders, alcohol or drug abuse, or any other clinically significant disease or condition).

Trial Locations

• Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China

Frequently Asked Questions

Related Conditions

• Breast cancer, HER2-positive breast cancer, adjuvant therapy, oncology

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