NCT06198751进行中（未招募）2 期
A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of TQB2102 for Injection for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 7
- 主要终点
- Total physiological complete response (tpCR)
研究概览
简要总结
To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.
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 and sign informed consent;
- •Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; expected survival of more than 3 months;
- •Histologically confirmed invasive breast cancer, no history of any systemic anti-tumor therapy for breast cancer;
- •Confirmed as HER2 positive;
- •Clinical stage at the time of visit is T0-4, N1-3, M0 or T2-4, N0, M0;
- •Agree to undergo breast cancer surgery when reaching the surgical criteria after neoadjuvant therapy;
- •Major organ functions are good, meeting certain criteria;
- •Agree to use contraception during the study and within 6 months after the study ends; female patients must have a negative serum pregnancy test within 7 days before enrollment and must be non-lactating.
排除标准
- •IV stage metastatic breast cancer or deemed unable to achieve curative surgical resection through neoadjuvant therapy by other investigators.
- •Bilateral invasive breast cancer.
- •Coexisting diseases and medical history:
- •History of invasive breast cancer.
- •Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
- •Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
- •Unhealed wounds or fractures.
- •Ocular diseases deemed clinically significant by the investigator.
- •Occurrence of arterial/deep venous thrombotic events within the last 6 months.
- •History of substance abuse with inability to quit or individuals with mental disorders.
- •≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
- •Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
- •History of interstitial lung disease/pneumonia requiring intervention with steroid treatment, or current presence, or suspected interstitial lung disease/pneumonia during the screening period that cannot be ruled out by the investigator; individuals with pulmonary diseases deemed unsuitable for participation by the investigator.
- •Tumor-related symptoms and treatment:
- •Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.
- •Received traditional Chinese medicine treatment with indications for anti-tumor effects within 2 weeks before the start of the study.
- •Radiological evidence of tumor invasion into major vessels or judged by the investigator to be highly likely to invade major vessels during the subsequent study period, leading to fatal hemorrhage.
- •Study treatment-related:
- •Experienced severe hypersensitivity reactions after using monoclonal antibodies.
- •Developed uncontrollable active autoimmune diseases within 2 weeks before the start of the study.
- •Allergic to any component or excipient in any study drug.
- •Participated in other clinical trials of anti-tumor drugs within 4 weeks before the start of the study.
- •Deemed inappropriate for inclusion based on the investigator's judgment.
研究组 & 干预措施
6 mg/kg of TQB2102 for injection
Experimental
6 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles.
干预措施: 6.0 mg/kg of TQB2102 for injection (Drug)
7.5 mg/kg of TQB2102 for injection
Experimental
7.5 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles.
干预措施: 7.5 mg/kg of TQB2102 for injection (Drug)
结局指标
主要结局
Total physiological complete response (tpCR)
时间窗: Up to 12 months.
The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer and the regional lymph nodes are negative.
次要结局
- Breast pathological complete (bpCR) response(Up to 12 months.)
- Objective response rate (ORR)(Up to 12 months.)
- Event-free survival (EFS)(Up to 60 months.)
- Invasive Disease-free survival (IDFS)(Up to 60 months.)
- The occurrence rate of all adverse events (AEs)(From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.)
- The severity of all adverse events (AEs)(From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.)
- Anti-drug antibody (ADA)(1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 6 Day1, Cycle 8 Day1, and 90 days after the end of the last infusion. Each cycle is 21 days.)
- Overall survival (OS)(Up to 60 months after study start)
研究者
研究点 (7)
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