A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 107
- 主要终点
- Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
研究概览
简要总结
This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens or patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+, ISH-) breast cancer who have received at least a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
详细描述
The primary objective of the study is to evaluate real-world time to next treatment or date of death from index date (T-DXd treatment initiation date)(rwTTNT) in each cohort. The secondary objectives of this study are to describe treatment patterns in eligible patients with HER2+ or HER2-low unresectable or mBC who are newly initiating T-DXd in a real-world setting, to describe demographic and clinical characteristics, to assess the safety and tolerability through the collection of physician-reported SEIs, to characterize the management of SEIs, to evaluate real-world time to treatment discontinuation (rwTTD) of T-DXd, and to evaluate patient-reported tolerability.
This decision to treat the patient with T-DXd will be made prior to, and independent of, their participation in this study. Eligible patients willing to participate will be enrolled consecutively in the study and followed up from index date (T-DXd treatment initiation date) until end of study, death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first.
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
- •to be eligible for the study:
- •≥18 years of age at time of consent.
- •Pathologically documented breast cancer that is unresectable or metastatic.
- •Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings.
- •Cohort B: Patients with confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-); and patients have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; and patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings.
- •Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China.
- •Capable of providing informed consent.
- •Patients capable of completing questionnaires are preferred. If the participant is unable to complete the questionnaire (e.g., being blind, illiterate, not fluent in the available language, or ePRO system is not ready), that participant is exempted from completing PRO questionnaires but may still participate in the study.
- •Patients who meet any of the following criteria will be excluded from the study:
- •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.
- •Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.
- •Patients who have been judged by the investigator to be unfit to participate the study.
排除标准
- 未提供
研究组 & 干预措施
Cohort A
Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.
干预措施: Trastuzumab deruxtecan (Drug)
Cohort B
Patients with unresectable or metastatic HER2-low breast cancer patients who have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
干预措施: Trastuzumab deruxtecan (Drug)
结局指标
主要结局
Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
时间窗: Assessed over a 36-month period
Time to next treatment or death from index date will be assessed.
次要结局
- Change in T-DXd Dosing in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer(Assessed over a 36-month period)
- Duration of Treatment (DoT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer(Assessed over a 36-month period)
- Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer(Assessed over a 36-month period)
- Percentage of Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinical Characteristics(Assessed over a 36-month period)
- Number of Participants Reporting Physician-reported Safety Events of Interest (SEI) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer(Assessed over a 36-month period)
- Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management(Assessed over a 36-month period)
- Real-world Time to Discontinuation (rwTTD) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer(Assessed over a 36-month period)
- Change in Patient's Global Impression of Treatment Tolerability in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer(Baseline up to 1 month post-T-DXd treatment)
- Number of Participants Reporting Symptom Items From National Cancer Institute Patient Reported Outcome Common Terminology Criteria for Adverse Events(Baseline up to 1 month post-T-DXd treatment)
- Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data(Baseline up to 1 month post-T-DXd treatment)