Breast Cancer, HER2 + Breast Cancer
Conditions
Keywords
HER2 positive, neoadjuvant therapy
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.
Interventions
DRUGTQB2102
TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.
DRUGDocetaxel + 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.
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | up to 180 days | pCR was defined as ypT0/Tis ypN0 at surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free Survival (EFS) | 5-10 years | EFS was defined as time from randomization to invasive progression (local/distant), recurrence, or death. |
| Adverse Event (AE) | up to 180 days | — |
| Overall Survival (OS) | 5-10 years | OS was measured from randomization to death from any cause. Patients without documented death were censored at the last contact date. |
| Objective Response Rate （ORR） | up to 180 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| PCR in Pre-Specified subgroup analysis | up to 180 days | PCR in subgroups defined by HR status，HER2 IHC and clinical stages |
Countries
China
Contacts
Primary ContactZhenzhen Liu
Outcome results
None listed