NCT07416253
尚未招募
2 期
A Randomized, Open-Label, Phase II Study Comparing the Efficacy and Safety of Trastuzumab-rezetecan and Trastuzumab Deruxtecan (T-DXd) in Neoadjuvant Treatment of Patients With HER2-Positive Early or Locally Advanced Breast Cancer
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 68
- 主要终点
- Pathological Complete Response Rate
概览
简要总结
This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles. After completing neoadjuvant treatment, patients will undergo definitive surgery, and tpCR will be assessed from resected specimens. Patients will then be followed up to monitor long-term efficacy (e.g., EFS) and late-onset adverse events. A total of 68 patients (34 per arm) will be enrolled to achieve the study's statistical objectives.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18-75 years old, treatment-naive
- •ECOG PS 0-1
- •Histologically confirmed HER2+ (IHC 3+ or IHC 2+/ISH+) early/locally advanced breast cancer (AJCC 8th: cT2-cT4 any N cM0) or cT1c N+ cM0; known ER/PR status
- •Adequate organ function (hematology/biochemistry/coagulation/urine/cardiac)
- •Negative pregnancy test (childbearing women); agree to effective contraception
- •Sign an informed consent form.
排除标准
- •Bbilateral/inflammatory/occult breast cancer.
- •Prior anti-tumor therapy (chemotherapy/radiotherapy/targeted therapy, etc.); radical radiotherapy (4 weeks prior) or palliative radiotherapy (2 weeks prior) to first dose.
- •Concurrent anti-tumor therapy; other malignancies (within past 5 years, except cured basal cell carcinoma/cervical CIS).
- •Prior trial participation (past 4 weeks); systemic immunosuppressants/hormones (\>10 mg/day prednisone equivalent, 2 weeks prior; nasal/inhaled steroids excluded).
- •Live/attenuated vaccine (past 4 weeks); major non-breast surgery (4 weeks prior, incomplete recovery).
- •Active/relapsing autoimmune disease (except controlled hypothyroidism/well-managed skin diseases/type 1 diabetes); immunodeficiency (HIV+/organ transplant).
- •Uncontrolled cardiovascular/cerebrovascular disease (e.g., MI/stroke in 6 months, NYHA III-IV heart failure, QTcF \>470 msec \[female\]).
- •Active ILD/severe lung disease; active hepatitis B (HBsAg+ \& HBV DNA ≥500 IU/mL)/hepatitis C (HCV RNA+); severe infection requiring anti-infective therapy.
- •Bleeding/thrombotic tendency; hypersensitivity to study drugs/excipients.
- •Pregnant/lactating women; women of childbearing potential with positive pregnancy test or refusing contraception.
研究组 & 干预措施
trastuzumab-rezetecan group
Experimental
干预措施: Trastuzumab rezetecan (Drug)
trastuzumab deruxtecan group
Active Comparator
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Pathological Complete Response Rate
时间窗: 3 to 8 weeks after neoadjuvant treatment completion
次要结局
- QLQ-BR23(within 1 year after randomization)
- Adverse enents(First dose to 30 days after last dose)
- Objective Response Rate (ORR)(Within 6 months after randomization)
- Event-Free Survival (EFS)(5-10 years)
- EORTC QLQ-C30(Within 1 year after randomization)
- 3-Year Event-Free Survival (EFS) Rate(3 years after randomization)
研究者
Zhenzhen Liu
Professor
Henan Cancer Hospital
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