KN026 plus HB1801 with chemotherapy as adjuvant treatment after surgery for resectable HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, multicenter Phase III trial comparing KN026 combined with HB1801 plus chemotherapy to the standard trastuzumab plus pertuzumab with chemotherapy as adjuvant treatment for patients with resectable HER2-positive breast cancer. Eligible participants are adults who have had definitive breast surgery and have pathologically positive regional lymph nodes, good performance status, and adequate organ function. Participants will be assigned to one of the two treatment arms and followed for safety and efficacy outcomes, including recurrence and survival endpoints. The protocol requires cardiac monitoring and standard laboratory testing given the known cardiac and hematologic risks of HER2-targeted agents and chemotherapy.

Why it matters

Who can join: the full rules

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).

Where it's running

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

Study contacts

• Study coordinator: Clinical Trials Information Group officer
• Email: ctr-contact@cspc.cn
• Phone: 0311-69085587

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Olaparib with Trastuzumab and Pertuzumab before surgery for older women with HER2-positive breast cancer

  This trial tests whether adding olaparib to standard HER2-targeted therapy can help older women with newly diagnosed, operable HER2-positive breast cancer before surgery.

  Recruiting Phase 4 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT07695259

• Paclitaxel micelles with HER2-targeted therapy vs standard taxane-based therapy as first-line treatment for advanced HER2-positive breast cancer

  This study tests whether paclitaxel polymer micelles plus trastuzumab, pertuzumab, and ad Adelumab can better treat advanced HER2-positive breast cancer compared with the usual taxane-based therapy plus trastuzumab and pertuzumab.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07581795

• BL-M07D1 plus pertuzumab vs standard therapy in first-line HER2-positive breast cancer

  A Phase 3 trial tests whether adding BL-M07D1 to pertuzumab is as good as or better than docetaxel plus trastuzumab and pertuzumab in patients with newly diagnosed, unresectable or metastatic HER2-positive breast cancer.

  Recruiting at 2 sites Phase 3 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong and 1 other locations · NCT07518173

• Pre-surgery trastuzumab deruxtecan (SHR-A1811) plus pertuzumab for HER2-positive breast cancer

  This trial tests giving trastuzumab deruxtecan (SHR-A1811) with pertuzumab before surgery to see if it helps women with stage II–III HER2-positive breast cancer achieve a complete response.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07393425

• IBI354 with or without pertuzumab versus taxane plus trastuzumab and pertuzumab for HER2-positive metastatic breast cancer

  This trial tests whether IBI354, with or without pertuzumab, works better than standard taxane plus trastuzumab and pertuzumab as first-line treatment for adults with HER2-positive unresectable locally advanced or metastatic breast cancer.

  Recruiting Phase 3 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Beijing, Beijing Municipality · NCT07377643

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.