Trastuzumab Rezetecan Plus Pertuzumab as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Open-label, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- pCR rate
研究概览
简要总结
This is a prospective, open-label, phase II study evaluating the efficacy and safety of Trastuzumab Rezetecan in combination with pertuzumab in early or locally advanced HER2-positive breast cancer.
详细描述
Patients with early-stage or locally advanced HER2-positive breast cancer were planned to be enrolled and subjected to neoadjuvant therapy with the regimen of Trastuzumab Rezetecan combined with Pertuzumab. The primary objective was to evaluate the efficacy and safety of Trastuzumab Rezetecan plus Pertuzumab as neoadjuvant treatment for early-stage or locally advanced HER2-positive breast cancer. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-70 years;
- •Histopathologically confirmed HER2 positive breast cancer;
- •Patients were diagnosed with stage II-III breast cancer;
- •At least one measurable target lesion according to RECIST V1.1;
- •ECOG performance status score of 0 to 1;
- •Life expectancy ≥12 weeks;
- •Adequate bone marrow reserve and organ system function reserve;
- •Participants should be able and willing to comply with the study protocol requirement;
排除标准
- •Breast cancer not histologically confirmed;
- •Known inherited or acquired bleeding and thrombotic tendencies;
- •Known allergy or contraindication to the study drug and its excipients;
- •Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- •Concurrent receipt of any other form of anti-cancer therapy;
- •History of a second primary malignancy, except for adequately treated skin cancer;
- •Participation in other drug clinical trials within 4 weeks before enrollment;
- •Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
- •Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
- •Uncontrolled or significant cardiovascular and cerebrovascular diseases;
- •Subjects with known or suspected interstitial pneumonia;
- •Presence of active hepatitis B, hepatitis C, liver cirrhosis;
- •Pregnant or lactating female patients;
- •History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.
研究组 & 干预措施
Treatment group
Trastuzumab Rezetecan; Pertuzumab
干预措施: Trastuzumab Rezetecan (Drug)
Treatment group
Trastuzumab Rezetecan; Pertuzumab
干预措施: Pertuzumab (Drug)
结局指标
主要结局
pCR rate
时间窗: At the time of surgery
Total pathological complete response (tpCR: ypT0-is，ypN0)
次要结局
- ORR(Up to approximately 24 weeks after the first administration)
- EFS(Up to approximately 5 years)
- iDFS(Up to approximately 5 years)
- AEs(From the first dose until 30 days after last dose)
研究者
Zhenzhen Liu
Professor
Henan Cancer Hospital