Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Real world response rate (rwRR)
研究概览
简要总结
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US
详细描述
This study is a multicenter, hybrid, observational study of approximately 100 prospectively enrolled patients with HER2-positive (IHC 3+) solid tumors in the US initiated on trastuzumab deruxtecan (T-DXd) as per FDA label in routine clinical practice and enrolled at the point of starting treatment with T-DXd. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options will be eligible for inclusion. Patients with breast, colorectal, non-small cell lung cancer (NSCLC), gastric/gastroesophageal junction (GEJ) cancers, and haematological malignancies are not eligible for this study.
Approximately 30 sites will be selected including community oncology practices, hospital systems and academic medical centers (AMCs), with a focus on enrolling a patient population representative of real-world care with the majority of patients from community settings. The primary objective of the study is to assess real world response rate and real world duration of response, and the secondary objective is to assess real world time to treatment discontinuation and real world time to next treatment.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years
- •Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);
- •A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;
- •HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;
- •Patients who are willing and able to provide a signed and dated informed consent.
排除标准
- •Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;
- •Prior T-DXd therapy;
- •Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.
- •Patient is participating in a clinical trial at time of enrolment
研究组 & 干预措施
Trastuzumab deruxtecan
Patients with locally advanced, unresectable, or metastatic HER-2 positive (IHC3+) solid tumours for whom a clinician decision has been made for treatment with T-DXd as part of routine clinical practice and in line with the FDA label
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Real world response rate (rwRR)
时间窗: Through study completion, up to 2.5 years after enrolment
rwRR is defined as the proportion of patients with a clinician assessment of complete or partial response while on T-DXd treatment
Real world duration of response (rwDoR)
时间窗: Through study completion, up to 2.5 years after enrolment
rwDoR is defined as the time from first physician reported complete or partial response until time of progression or death
次要结局
- Real world time to treatment discontinuation (rwTTD)(Through study completion, up to 2.5 years after enrolment)
- Real world time to next treatment (rwTTNT)(Through study completion, up to 2.5 years after enrolment)