Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Comparison of mean levels of cytokine and T-DXd toxicity
研究概览
简要总结
the anti-Human Epidermal Growth Factor Receptor 2 (HER2) Trastuzumab-Deruxtecan (T-DXd) has shown impressive clinical activity in pretreated patients with metastatic breast cancer (MBC) but is also associated with a non-negligible rate of adverse events that may lead to treatment discontinuation and/or the onset of pneumonitis/interstitial lung disease (ILD)
The aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities
详细描述
Despite advanced in diagnosis and in the treatment management, advanced breast cancer (ABC) is still an incurable disease.
Recent pharmaceutical developments have changed treatment algorithms in MBC and have further improved the overall prognosis of patients which exploit the tumor-targeting activity of monoclonal antibodies to deliver at the tumor site potent chemotherapeutic agents that would otherwise be exceedingly toxic if delivered systemically.
Among them, new effective anticancer drugs, such as Trastuzumab-Deruxtecan (T-DXd), have revolutionized the clinical management of HER2-positive and HER2-low ABC. However, this drug is associated with a non-negligible rate of adverse events that can lead to treatment discontinuation and/or the onset of pneumonitis/interstitial lung disease (ILD), a potentially fatal adverse event.
The aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities (both any grade ILD/pneumonitis and any toxicity of grade ≥3) in a population of patients treated with T-DXd according to standard clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged at least 18 years.
- •Histologically documented invasive breast cancer, either HER2-positive or HER2-low/ultralow.
- •Candidate to receive T-DXd as per standard practice.
- •Consent for the provision of blood samples for exploratory analyses.
排除标准
- •Operable, non-metastatic breast cancer
- •Unwillingness to provide additional blood draws
结局指标
主要结局
Comparison of mean levels of cytokine and T-DXd toxicity
时间窗: 2 years
cytokine quantification in blood sample collected at baseline and before cycle 3 day 1
次要结局
- Incidence of T-DXd Treatment Adverse Events(2 years)
- T-DXd activity evaluation(8 months)