A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
- Conditions
- HER2-positive Breast CancerHER2-low Breast CancerBreast CancerAdvanced Cancer
- Interventions
- Registration Number
- NCT06210776
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A Trastuzumab deruxtecan Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens. Cohort B Trastuzumab deruxtecan 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.
- Primary Outcome Measures
Name Time Method Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer Assessed over a 36-month period Time to next treatment or death from index date will be assessed.
- Secondary Outcome Measures
Name Time Method 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 Duration of treatment is defined as the length of time a patient is treated.
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 Time to discontinuation is defined as time from index date to the earliest date of T-DXd discontinuation, or date of death.
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
Trial Locations
- Locations (54)
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
The First People's Hospital of Foshan
🇨🇳Foshan, China
Peking University First Hospital
🇨🇳Beijing, China
The Fifth Medical Center of the Chinese PLA General Hospital
🇨🇳Beijing, China
Peking University Shougang Hospital
🇨🇳Beijing, China
Beijing GoBroad Hospital
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Sichuan Cancer Hospital
🇨🇳Chengdu, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
🇨🇳Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, China
Hainan Cancer Hospital
🇨🇳Haikou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Anhui Provincial Cancer Hospital
🇨🇳Hefei, China
Jiamusi Cancer Hospital
🇨🇳Jiamusi, China
Yunnan Cancer Hospital
🇨🇳Kunming, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, China
The First Affiliated Hospital of Henan University of Science & Technology
🇨🇳Luoyang, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, China
Nanchang Third Hospital
🇨🇳Nanchang, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
The Peoples of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, China
Affiliated Hospital Of Nantong University
🇨🇳Nantong, China
Ningbo No.2 Hospital
🇨🇳Ningbo, China
Qingdao Central Hospital
🇨🇳Qingdao, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Changhai Hospital
🇨🇳Shanghai, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, China
The University of Hong Kong- Shenzhen Hospital
🇨🇳Shenzhen, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
🇨🇳Shenzhen, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, China
Tangshan People's Hospital
🇨🇳Tangshan, China
Tianjin Cancer Hospital Airport Hospital
🇨🇳Tianjin, China
Weifang People's Hospital
🇨🇳Weifang, China
Wenzhou Central Hospital
🇨🇳Wenzhou, China
Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Wulumuqi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
The First Affilital of Xiamen University
🇨🇳Xiamen, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, China
Xi'an International Medical Center Hospital
🇨🇳Xian, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, China
Henan Cancer Hospital
🇨🇳Zengzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
Zhongshan City People's Hospital
🇨🇳Zhongshan, China
The Fifth Affiliated Hospital, Sun Yat-sen University
🇨🇳Zhuhai, China