Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.

NCT ID: NCT07136974

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-08-30

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 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Patients will undergo definitive surgery (breast conservation or mastectomy with sentinel lymph-node evaluation or axillary dissection) 3 to 6 weeks after the last cycle of the neoadjuvant phase. Primary endpoint is pathological complete response, defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery.

Conditions

Breast Cancer; HER2 + Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2102 group

TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.

Group Type: EXPERIMENTAL

TQB2102

Intervention Type: DRUG

TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.

TCbHP

Docetaxel + carboplatin + trastuzumab + pertuzumab (every 3 weeks)

Group Type: ACTIVE_COMPARATOR

Docetaxel + Carboplatin + Trastuzumab +Pertuzumab

Intervention Type: DRUG

Docetaxel 75 mg/m2(day 1) , Carboplatin (AUC=6) (day 1), Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Pertuzumab (840mg first dose, 420mg/kg sequential) are administered intravenously every 3 weeks for 6 cycles.

Interventions

TQB2102

TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.

Intervention Type: DRUG

Docetaxel + Carboplatin + Trastuzumab +Pertuzumab

Docetaxel 75 mg/m2(day 1) , Carboplatin (AUC=6) (day 1), Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Pertuzumab (840mg first dose, 420mg/kg sequential) are administered intravenously every 3 weeks for 6 cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18-70 years,

2. ECOG performance status 0-1;

3. 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);

4. Clinically measurable lesion: Lesion measurable by ultrasound, mammography, or optional MRI within 1 month before randomization;

5. 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%;

6. For women of childbearing potential: Negative serum pregnancy test within 14 days before randomization;

7. Signed informed consent form.

Exclusion Criteria

1. Stage IV (metastatic) breast cancer;

2. 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;

3. Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or incomplete recovery from such procedures;

4. 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);

5. Contraindications to chemotherapy per investigator's assessment due to severe uncontrolled comorbidities;

6. Known hypersensitivity to protocol drug components;

7. History of immunodeficiency disorders (including HIV positivity), other acquired/congenital immune deficiencies, or organ transplantation;

8. Any concurrent condition that in the investigator's judgment would jeopardize patient safety or compromise study completion, or other grounds for ineligibility.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhenzhen Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henan cancer hospital

Zhengzhou, Henan, China

Countries

China

Central Contacts

Zhenzhen Liu

Role: CONTACT

zlyyliuzhenzhen0800@zzu.edu.cn

13603862755

Other Identifiers

HELEN-025

Identifier Type: -

Identifier Source: org_study_id