Tolerability and Efficacy of Adjuvant T-DM1 in Patients With HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study. ATD-Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Evaluate the tolerability.
研究概览
简要总结
Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized.
详细描述
Patients affected by will be included in the study and analyzed HER2 positive breast cancer with residual invasive disease after neoadjuvant chemotherapy, treated consecutively with adjuvant T-DM1 at the various Italian oncology centers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of HER2 positive breast cancer;
- •Presence of invasive residual disease on T or N after neoadjuvant chemotherapy including anti-HER2 agents
- •Treatment with T-DM1 in the adjuvant post-neoadjuvant setting, in case of positive hormone receptors in combination with adjuvant hormone therapy. Complementary radiotherapy will be allowed as per lines guide;
- •Availability of adequate information regarding treatment with adjuvant T-DM1 in accordance with the objectives of the study;
- •Written informed consent for the prospective part and, if possible, for the recruited patients retrospectively
排除标准
- •Concomitant treatments with other biological agents;
- •Absence of clinical data that allow the correct analysis of the primary and secondary objectives;
- •Patients with a history of other malignant neoplasms;
- •Contraindications to the use of T-DM
研究组 & 干预措施
Retrospective cohort
80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized
干预措施: T-DM1 adjuvant (Drug)
Prospectively cohort
Additional 80 patients who meet the inclusion criteria will be enrolled prospectively
干预措施: T-DM1 adjuvant (Drug)
结局指标
主要结局
Evaluate the tolerability.
时间窗: 24 months
Evaluate the tolerability of the treatment in terms of adverse events, defined according to Common Terminology Criteria for Adverse Events (CTCAE, version 4), in a population of patients treated with adjuvant T-DM1 in "real life"
次要结局
- Evaluate the effectiveness of treatment.(24 months)