NCT07043725招募中3 期
A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.76 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2025年9月15日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 544
- 试验地点
- 76
- 主要终点
- Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC)
研究概览
简要总结
This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this study, sign the informed consent form, and have good compliance;
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival >6 months;
- •Histologically or cytologically confirmed HER2-positive invasive breast cancer;
- •Hormone receptor (HR) status confirmed;
- •Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0;
- •Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy;
- •Major organ function is adequate, meeting specific criteria;
- •Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion
排除标准
- •Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;
- •Bilateral breast cancer or inflammatory breast cancer;
- •History of invasive breast cancer or ductal carcinoma in situ;
- •Prior anti-tumor therapy for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, surgery, etc.;
- •Comorbidities and medical history:
- •Other malignancies within 5 years or currently;
- •Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1;
- •Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures;
- •Conditions affecting intravenous injection or blood sampling;
- •Congenital bleeding or coagulation disorders, or bleeding/coagulation disorders within 28 days before study treatment, or use of aspirin >325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment;
- •Arterial/deep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism;
- •Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);
- •Significant cardiovascular disease, including；
- •Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment;
- •History of interstitial lung disease/pneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease/pneumonitis, or suspected interstitial lung disease/pneumonitis on screening imaging that cannot be ruled out;
- •Tumor-related symptoms and treatment:
- •Prior excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy before study treatment;
- •Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment);
- •Prior taxane or carboplatin therapy for any malignancy;
- •Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment.
- •Study treatment-related:
- •Severe hypersensitivity to monoclonal antibodies;
- •Uncontrolled active autoimmune disease within 2 weeks before study treatment;
- •Allergy to any study drug or its components/excipients;
- •Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines.
- •Any condition judged by the investigator to jeopardize subject safety or study completion.
研究组 & 干预措施
TQB2102 for injection
Experimental
6mg/kg TQB2102 for injection, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 8 cycles.
干预措施: TQB2102 for injection (Drug)
Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
Active Comparator
Trastuzumab injection (The first dose is 8mg/kg, followed by 6mg/kg), Pertuzumab Injection (The first dose is 840, followed by 420mg), Docetaxel Injection (75mg/m2 ) combined with Carboplatin Injection (AUC-6, 800 mg max), Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6 cycles.
干预措施: Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection (Drug)
结局指标
主要结局
Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC)
时间窗: Up to 26 months after study start
Rate of subjects with no residual invasive cancer in the primary breast lesion and negative regional lymph nodes upon microscopic examination after primary tumor resection, as assessed by IRC.
次要结局
- Rate of total physiological complete response (tpCR) evaluated by the investigator(Up to 24 months after study start)
- Breast pathological complete response (bpCR) evaluated by IRC and the investigator(Up to 26 months after study start)
- Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb)(Up to 22 months after study start)
- Objective response rate (ORR)(Up to 22 months after study start)
- There year Event-free survival (EFS)(Up to 50 months after study start)
- Overall Survival (OS)(Up to 50 months after study start)
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests(From the date of signing the informed consent to 40 days after the last dosing or radical mastectomy for breast cancer or a new anti-tumor treatment, whichever comes first.)
- There year Invasive Disease-free survival (IDFS)(Up to 50 months after study start)
研究者
研究点 (76)
Loading locations...
相似试验
招募中
3 期
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast CancerBreast CancerNCT07003074Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.642
已完成
3 期
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionNCT02932410Actelion165
尚未招募
3 期
JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins MutationsLocal Advanced or Metastatic NSCLCNCT06380348Shanghai JMT-Bio Inc.398
招募中
3 期
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial CancerUrothelial CarcinomaNCT06592326Mabwell (Shanghai) Bioscience Co., Ltd.460
招募中
3 期
OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)NCT06781944Huashan Hospital144