NCT06125834招募中2 期
Trastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are:
- The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy.
- The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy.
- Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer.
Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.
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
- •Age ≥ 18 years; pregnancy test (-) for premenopausal and perimenopausal patients, promising to use reliable contraception during treatment.
- •Patients who were be diagnosed with invasive breast cancer according to the eighth edition of American Joint Committee on Cancer (AJCC) staging system, and develop disease progression after anti-HER2 therapy (TKIs) for stage IV disease at initial diagnosis or within one year of adjuvant anti-HER2 therapy (HP) after surgery for early breast cancer.
- •At least one measurable lesion according to RECIST 1.
- •ECOG score of 0 or
- •The organ function is still good and meets the following indicators: hemoglobin ≥ 90g/L, white blood cell ≥ 3.5×10^9/L, platelet ≥ 100×10^9/L, neutrophil ≥ 1.5×10^9/L, aspartate aminotransferase or alanine aminotransferase ≤ 3×ULN, total bilirubin ≤ 1.5×ULN, serum creatinine value ≤ 1.5×ULN.
- •Without myocardial ischemia in ECG.
- •NYHA grade I; Echocardiography LVEF ≥55%; Cardiac markers: cardiac troponin (cTnI) and brain natriuretic peptide (BNP) within normal range.
- •Complete all necessary baseline laboratory and radiological tests prior to treatment.
- •Complete clinical data.
排除标准
- •male breast cancer or inflammatory breast cancer.
- •Patients who have other malignant tumors or have contracted malignant tumors other than breast cancer in the past 5 years, except for basal cell carcinoma of the skin or flat cell carcinoma and carcinoma in situ of the cervix that have been adequately treated and controlled.
- •Accompanying other anti-tumor treatments or participating in other clinical trials.
- •Serious diseases that will affect the patient's compliance or put the patient at risk.
- •Major surgical procedures performed within 4 weeks prior to the commencement of study treatment or anticipated major surgical procedures during the course of the study.
- •Patients who have used ADC drugs at present or before this study.
- •History of allergic reactions or contraindications to use of any drug ingredient in this study.
- •Patients with chronic diarrhea and intestinal obstruction, as well as other diseases that affect drug administration and absorption.
- •Patients who have clinical cardiac symptoms or diseases that are not well controlled, such as: heart failure above NYHA 2; unstable angina; myocardial infarction occurred within one year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- •Dementia, intellectual abnormality, or any mental illness that interferes with the understanding of informed consent.
研究组 & 干预措施
T-DM1 treatment group
Experimental
Trastuzumab Emtansine (T-DM1), 3.6mg/kg, d1/21, IVD, until progressive diseases or intolerable adverse effects occurs
干预措施: Trastuzumab Emtansine (T-DM1) (Drug)
结局指标
主要结局
Objective response rate
时间窗: up to 12 months
次要结局
- Tumor related parameters(up to 12 weeks)
- Progression-free survival(up to 36 months)
- Antitumor immunity related parameters(up to 12 weeks)
- Adverse events(every 6 weeks)
- Overall survival(up to 36 months)
研究者
研究点 (1)
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