Performance of Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early Triple-Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Pathological Complete Response (PCR)
研究概览
简要总结
The goal of this observational, retrospective, non interventional study is to learn about the efficacy of an Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early Triple-Negative Breast Cancer (TNBC).
The main question it aims to answer is :
- What is the efficacy of this kind of treatment, by evaluating the pathological complete response (PCR), that is to say, the percentage of patients where no tumor cells remained when they underwent surgery after neoadjuvant treatment.
The other points that will be evaluated are:
- The treatment regimen
- The epidemiological characteristics of the treated population
- The efficacy by relapse-free survival ; overall survival
- The tolerability and adverse effects
The standard treatment for localized TNBC (larger than 2 cm or with lymph node involvement) is neoadjuvant chemoimmunotherapy, which includes anthracyclines. However, in real-world practice, some patients have a contrindication to this treatment because they have received it previously, are too old, or have comorbidities, particularly cardiovascular disease. Currently, there is limited data on the modalities and efficacy of such treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients over 18 years of age
- •Patients being treated for localized triple-negative breast cancer, who received neoadjuvant chemotherapy with immunotherapy, without anthracycline
- •Patients who have undergone surgery, with an available pathology report.
排除标准
- •Patient refusal to allow data use
- •Patient who has not undergone surgery
- •Metastatic patients
- •Patients who have received at least one anthracycline-based treatment cycle
结局指标
主要结局
Pathological Complete Response (PCR)
时间窗: At Surgery
次要结局
- Type of treatment anthracycline-free(Baseline)
- Adverse Effects(6-48 months according to treatment start)
- Epidemiologic description of the population treated(Baseline)