NCT07136974尚未招募2 期
Comparing the Efficacy of TQB2102 and TCbHP in Neoadjuvant Treatment for HER2-positive Early Breast Cancer: A Randomized Phase II Clinical Trial.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
TQB2102 group
Experimental
TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.
干预措施: TQB2102 (Drug)
TCbHP
Active Comparator
Docetaxel + carboplatin + trastuzumab + pertuzumab (every 3 weeks)
干预措施: Docetaxel + Carboplatin + Trastuzumab +Pertuzumab (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: up to 180 days
pCR was defined as ypT0/Tis ypN0 at surgery
次要结局
- 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)
研究者
Zhenzhen Liu
Professor
Henan Cancer Hospital
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract CancerBiliary Tract CancerNCT06431490Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.102
招募中
2 期
The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast CancerBreast CancerNCT06452706Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.42
招募中
不适用
Phase II study of the 2nd line Nab-PTX/CBDCA combination therapy for advanced non-small cell lung cancer which is previously treated with platinum-based chemotherapyon-small cell lung cancerJPRN-UMIN000011669Dokkyo Medical University40
进行中（未招募）
2 期
A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast CancerBreast CancerNCT06198751Chia Tai Tianqing Pharmaceutical Group Co., Ltd.104
已完成
2 期
Phase II clinical study of nab-PTX/CBDCA (administer 3-weeks on / 1-week off) for patients with clinical stage IIIB/IV or recurrent NSCLClung cancerJPRN-UMIN000016255Shiga University of Medical Science5