About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
TQB2102
DrugTQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.
Docetaxel + Carboplatin + Trastuzumab +Pertuzumab
DrugDocetaxel 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.
Treatment groups
Trial outcomes
Primary outcomes
Pathological Complete Response (pCR)
pCR was defined as ypT0/Tis ypN0 at surgery
Secondary outcomes
Event-Free Survival (EFS)
EFS was defined as time from randomization to invasive progression (local/distant), recurrence, or death.
Adverse Event (AE)
Overall Survival (OS)
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)
Other outcomes
PCR in Pre-Specified subgroup analysis
PCR in subgroups defined by HR status,HER2 IHC and clinical stages
Sponsors and contacts
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