Status:
NOT_YET_RECRUITING
Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Breast Cancer
HER2 + Breast Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 rat...
Eligibility Criteria
Inclusion
- 18-70 years,
- ECOG performance status 0-1;
- Clinical T2-T4, or T1c with axillary lymph node metastasis; Confirmed HER2-positive status (per 2018 ASCO/CAP HER2 Testing Guidelines, defined as IHC 3+ or FISH positive);
- Clinically measurable lesion: Lesion measurable by ultrasound, mammography, or optional MRI within 1 month before randomization;
- No chemotherapy contraindications based on organ and bone marrow function tests within 1 month prior to chemotherapy: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, Hemoglobin ≥90 g/L, Platelet count ≥100×10⁹/L, Total bilirubin \<1.5 × ULN (upper limit of normal), Creatinine \<1.5 × ULN, AST/ALT \<1.5 × ULN, Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;
- For women of childbearing potential: Negative serum pregnancy test within 14 days before randomization;
- Signed informed consent form.
Exclusion
- Stage IV (metastatic) breast cancer;
- Prior treatments received including chemotherapy, endocrine therapy, targeted therapy, or radiotherapy; History of other malignancies within 3 years or concurrent malignancies. Exceptions: Other malignancies treated with surgery alone achieving ≥5-year disease-free survival (DFS) . Cured cervical carcinoma in situ or non-melanoma skin cancer;
- Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or incomplete recovery from such procedures;
- Significant cardiac disease or conditions including but not limited to: History of heart failure or systolic dysfunction (LVEF \<50%). Uncontrolled high-risk arrhythmias: Atrial tachycardia, resting heart rate \>100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (Mobitz II second-degree or third-degree AV block). Angina requiring anti-anginal medication. Clinically significant valvular heart disease. ECG evidence of transmural myocardial infarction. Poorly controlled hypertension (SBP \>180 mmHg and/or DBP \>100 mmHg);
- Contraindications to chemotherapy per investigator's assessment due to severe uncontrolled comorbidities;
- Known hypersensitivity to protocol drug components;
- History of immunodeficiency disorders (including HIV positivity), other acquired/congenital immune deficiencies, or organ transplantation;
- Any concurrent condition that in the investigator's judgment would jeopardize patient safety or compromise study completion, or other grounds for ineligibility.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT07136974
Start Date
September 1 2025
End Date
August 30 2030
Last Update
August 22 2025
Active Locations (1)
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1
Henan cancer hospital
Zhengzhou, Henan, China