A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Real-World Time to Next Treatment (rwTTNT)
研究概览
简要总结
This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in routine clinical practice.
详细描述
This is a multi-center, observational prospective study that will characterize the demographic and clinical characteristics, treatment patterns, effectiveness, tolerability and its management, and patient experience of Trastuzumab Deruxtecan (T-DXd) in a real-world setting. This study is planned to be conducted in several countries and aims to enroll approximately 750 patients eligible patients with HER2+ unresectable and/or metastatic breast cancer (mBC) who has received a prior anti HER2 based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and has developed disease recurrence during or within 6 months of completing therapy. Approximately 250 eligible patients with HER2-low unresectable and/or mBC who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy will be enrolled into the study in North America only.
The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients ≥18 years of age at time of consent.
- •Histological or cytological confirmed diagnosis of unresectable and/or mBC.
- •Documented HER2 status via a validated method.
- •Adult patients with unresectable or metastatic HER2+ breast cancer who have received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing therapy.
- •Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
- •Decision to newly initiate monotherapy T-DXd per standard of care.
- •Capable of providing informed consent and completing questionnaires.
排除标准
- •Pregnancy or breastfeeding.
- •History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis.
- •Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
结局指标
主要结局
Real-World Time to Next Treatment (rwTTNT)
时间窗: From first dose of T-DXd until study discontinuation (approximately 3 years)
Real-world time to next treatment will be evaluated. rwTTNT is defined as the length of time from date of first T-Dxd administration to the date the patient received an administration of their next systemic treatment regimen or to their date of death if there is a death prior to having another systemic treatment regimen.
T-Dxd treatment patterns for HER2+ cohort
时间窗: Approximately 3 years
Treatment patterns will be summarised using summary statistics.
次要结局
- Demographics and clinical charcteristics(At Baseline (14 to 30 days prior to T-DXd initiation))
- Symptomatic SEI as measured by selected items from National Cancer Institute Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)(Approximately 3 years)
- Daily Nausea and Vomiting symptom diary(From first dose of T-DXd until 3 months)
- T-Dxd treatment patterns for HER2-low(Approximately 3 years)
- Number of patients with Physician reported Safety Events of Interest (SEIs)(From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration))
- Number of patients provided prophylactic and reactive treatment for SEIs management(From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration))
- Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT)(Approximately 3 years)
- Real-World Time to Discontinuation (rwTTD)(From first dose of T-DXd until study discontinuation (approximately 3 years))