Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
详细描述
Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years
- •Expected survival ≥12 weeks
- •Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
- •At least one measurable lesion according to the RECIST 1.1
- •No history of antibody-drug conjugate use
- •Up to one previous chemotherapy for advanced disease
- •Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
- •HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in >0 but ≤10% of tumor cells
- •Adequate organ function
排除标准
- •History of thromboembolic events
- •Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
- •Active infections requiring systemic treatment
- •Pregnant or lactating
- •Presence of brain metastases and/or carcinomatous meningitis
研究组 & 干预措施
RC48-ADC
RC48-ADC as salvage treatment for HER2-low advanced breast cancer
干预措施: Disitamab vedotin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)
The percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people.Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
次要结局
- Adverse events(From the date of starting Disitamab Vedotin to the end of the treatment (up to approximately 1 year))
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital