A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)Low Europe)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,295
- 试验地点
- 410
- 主要终点
- Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
研究概览
简要总结
Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Based on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new patient population will be enrolled, comprising adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.
详细描述
This non-interventional study will investigate the effectiveness of T-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low and HER2-(ultra)low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study.
Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study. For Study Group 2, only baseline data will be collected for patients treated with conventional chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Study Group 1 and Study Group 2
- •Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
- •Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
- •Written and signed Informed Consent to participate in the study
- •Study Group 1
- •Documented HER2-low status (IHC1+, IHC2+/ISH-)
- •Patients who have received prior chemotherapy in the metastatic setting or
- •Patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
- •Study Group 2:
- •Documented HR+ status
- •Documented HER2-low status (IHC1+ or IHC2+/ISH-) or HER2-ultralow (defined as IHC 0 with membrane staining [IHC > 0 to <1+]) status
- •Patients who have received at least one endocrine therapy in the metastatic setting
- •Patients who have NOT received prior chemotherapy in the metastatic setting
排除标准
- •Study Group 1 and Study Group 2
- •Pregnancy or breastfeeding
- •Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
- •No other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
研究组 & 干预措施
Study Group 1
Adult participants with 2L+ HER2-low expressing unresectable and/or metastatic breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
In addition, patients with HER2-low breast cancer treated with conventional chemotherapy will be enrolled. The participants on conventional chemotherapy will be analyzed as exploratory only.
干预措施: Trastuzumab deruxtecan (Drug)
Study Group 2
Adult participants in the first-line setting with hormone receptor (HR) positive, HER2-low or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment and have not received prior chemotherapy for advanced metastatic breast cancer.
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
时间窗: Baseline up to 31 months
Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer
时间窗: Baseline up to approximately 37 months
次要结局
- Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer(Baseline up to 31 months)
- Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer(Baseline up to 31 months)
- Number of Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only)(Baseline up to 31 months)
- Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only)(Baseline up to 31 months)
- Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer(Baseline up to 31 months)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer(Baseline up to 31 months)
- Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary(Baseline up to 31 months)
- Type of Treatment Patterns in Participants With Unresectable and/or Metastatic Breast Cancer(Baseline up to approximately 37 months)
- Number of Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only)(Baseline up to approximately 37 months)
- Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only)(Baseline up to approximately 37 months)
- Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With Unresectable and/or Metastatic Breast Cancer(Baseline up to approximately 37 months)
- Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With Unresectable and/or Metastatic Breast Cancer(Baseline up to approximately 37 months)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With Unresectable and/or Metastatic Breast Cancer(Baseline up to approximately 37 months)
- Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary(Baseline up to approximately 37 months)