Clinical trial NCT06210776: A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Official title: A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-positive Breast Cancer
HER2-low Breast Cancer
Breast Cancer
Advanced Cancer
Keywords: HER2-positive breast cancer
HER2-low breast cancer
Breast cancer
Advanced cancer
Unresectable or metastatic breast cancer
Trastuzumab deruxtecan
T-DXd
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 800 eligible subjects with HER2+ or HER2-low unresectable or mBC will be enrolled in this study.

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.

Eligibility criteria: Patients must meet all of the following inclusion criteria to be eligible for the study:

1. ≥18 years of age at time of consent.
2. Pathologically documented breast cancer that is unresectable or metastatic.
3. 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.
4. 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.
5. Capable of providing informed consent.
6. 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:

1. Pregnancy or breastfeeding.
2. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
3. Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.
4. Patients who have been judged by the investigator to be unfit to participate the study.

Primary outcomes:
measure: Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 36-month period
Secondary outcomes:
measure: Change in T-DXd Dosing in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 36-month period
measure: Duration of Treatment (DoT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 36-month period
measure: Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 36-month period
measure: Percentage of Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinical Characteristics
timeFrame: Assessed over a 36-month period
measure: Number of Participants Reporting Physician-reported Safety Events of Interest (SEI) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 36-month period
measure: Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management
timeFrame: Assessed over a 36-month period
measure: Real-world Time to Discontinuation (rwTTD) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
timeFrame: Assessed over a 36-month period
measure: Change in Patient's Global Impression of Treatment Tolerability in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
timeFrame: Baseline up to 1 month post-T-DXd treatment
measure: Number of Participants Reporting Symptom Items From National Cancer Institute Patient Reported Outcome Common Terminology Criteria for Adverse Events
timeFrame: Baseline up to 1 month post-T-DXd treatment
measure: Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data
timeFrame: Baseline up to 1 month post-T-DXd treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: The Fifth Medical Center of the Chinese PLA General Hospital
city: Beijing
country: China
facility: Peking University Shougang Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing GoBroad Hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Haikou
country: China
facility: Hainan Cancer Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
city: Jiamusi
country: China
facility: Jiamusi Cancer Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanchang
country: China
facility: Nanchang Third Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanning
country: China
facility: The Peoples of Guangxi Zhuang Autonomous Region
city: Nantong
country: China
facility: Affiliated Hospital Of Nantong University
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
city: Qingdao
country: China
facility: Qingdao Central Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Changhai Hospital
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Shenzhen
country: China
facility: The University of Hong Kong- Shenzhen Hospital
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
city: Tangshan
country: China
facility: Tangshan People's Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
city: Weifang
country: China
facility: Weifang People's Hospital
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
city: Wulumuqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affilital of Xiamen University
city: Xian
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xian
country: China
facility: Xi'an International Medical Center Hospital
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital, Sun Yat-sen University
Study officials:
affiliation: Daiichi Sankyo China
name: Director
role: STUDY_DIRECTOR
References: