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

NCT07136974 | Not Yet Recruiting Phase 2

• 1 other identifier: HELEN-025
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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

Keywords

HER2 positive; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  pCR was defined as ypT0/Tis ypN0 at surgery

  up to 180 days

Secondary Outcomes (4)

• Event-Free Survival (EFS)

  5-10 years

• Adverse Event (AE)

  up to 180 days

• Overall Survival (OS)

  5-10 years

• Objective Response Rate （ORR）

  up to 180 days

Other Outcomes (1)

• PCR in Pre-Specified subgroup analysis

  up to 180 days

Study Arms (2)

TQB2102 group

EXPERIMENTAL

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

Drug: TQB2102

TCbHP

ACTIVE COMPARATOR

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

Drug: Docetaxel + Carboplatin + Trastuzumab +Pertuzumab

Interventions

TQB2102 DRUG

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

TQB2102 group

Docetaxel + Carboplatin + Trastuzumab +Pertuzumab 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.

TCbHP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Zhenzhen Liu

CONTACT

13603862755; zlyyliuzhenzhen0800@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2030
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (1)