A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Advanced Cancer; HER2-positive Breast Cancer; HER2-low Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab deruxtecan

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Daiichi Sankyo China; Phone Number: 0086-021-60397406; Email: yu.huan.m8@daiichisankyo.com.cn
• Study Contact Backup: Name: Daiichi Sankyo Contact for Clinical Trial Information; Phone Number: 9089926400; Email: CTRinfo_us@daiichisankyo.com

Study Locations

• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
    • Contact: Principal Investigator
  • Beijing, China, 100029
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Principal Investigator
  • Beijing, China, 100034
    • Recruiting
    • Peking University First Hospital
    • Contact: Principal Investigator
  • Beijing, China, 100144
    • Recruiting
    • Peking University Shougang Hospital
    • Contact: Principal Investigator
  • Beijing, China, 102206
    • Recruiting
    • Beijing GoBroad Hospital
    • Contact: Principal Investigator
  • Beijing, China, 100039
    • Withdrawn
    • The Fifth Medical Center of the Chinese PLA General Hospital
  • Chengdu, China, 610072
    • Recruiting
    • Sichuan Provincial People's Hospital
    • Contact: Principal Investigator
  • Chengdu, China, 610041
    • Recruiting
    • Sichuan Cancer Hospital
    • Contact: Principal Investigator
  • Dalian, China, 116001
    • Recruiting
    • Affiliated Zhongshan Hospital of Dalian University
    • Contact: Principal Investigator
  • Foshan, China, 528000
    • Recruiting
    • The First People's Hospital of Foshan
    • Contact: Principal Investigator
  • Fuzhou, China, 350000
    • Recruiting
    • Fujian Cancer Hospital
    • Contact: Principal Investigator
  • Guangzhou, China, 510120
    • Recruiting
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Contact: Principal Investigator
  • Guangzhou, China, 510060
    • Withdrawn
    • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
  • Haikou, China, 570311
    • Recruiting
    • Hainan Cancer Hospital
    • Contact: Principal Investigator
  • Hangzhou, China, 310022
    • Recruiting
    • Zhejiang Cancer Hospital
    • Contact: Principal Investigator
  • Hangzhou, China, 310009
    • Recruiting
    • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Contact: Principal Investigator
  • Harbin, China, 150081
    • Recruiting
    • Harbin Medical University Cancer Hospital
    • Contact: Principal Investigator
  • Hefei, China, 230031
    • Withdrawn
    • Anhui Provincial Cancer Hospital
  • Jiamusi, China, 154007
    • Recruiting
    • Jiamusi Cancer Hospital
    • Contact: Principal Investigator
  • Kunming, China, 650118
    • Withdrawn
    • Yunnan Cancer Hospital
  • Lianyungang, China, 222002
    • Recruiting
    • The first people's hospital of Lianyungang
    • Contact: Principal Investigator
  • Luoyang, China, 450052
    • Active, not recruiting
    • The First Affiliated Hospital of Henan University of Science & Technology
  • Nanchang, China, 330000
    • Recruiting
    • Jiangxi Cancer Hospital
    • Contact: Principal Investigator
  • Nanchang, China, 330000
    • Recruiting
    • Nanchang Third Hospital
  • Nanjing, China, 210008
    • Recruiting
    • Nanjing Drum Tower Hospital
    • Contact: Principal Investigator
  • Nanjing, China, 210029
    • Recruiting
    • Jiangsu Province Hospital
    • Contact: Principal Investigator
  • Nanning, China, 541000
    • Recruiting
    • The Peoples of Guangxi Zhuang Autonomous Region
    • Contact: Principal Investigator
  • Nantong, China, 226001
    • Recruiting
    • Affiliated Hospital of Nantong University
    • Contact: Principal Investigator
  • Ningbo, China, 315010
    • Withdrawn
    • Ningbo No.2 Hospital
  • Qingdao, China, 266042
    • Recruiting
    • Qingdao Central Hospital
    • Contact: Principal Investigator
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital
    • Contact: Principal Investigator
  • Shanghai, China, 200000
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Principal Investigator
  • Shantou, China, 515031
    • Recruiting
    • Cancer Hospital of Shantou University Medical College
    • Contact: Principal Investigator
  • Shenyang, China, 110000
    • Recruiting
    • Liaoning Cancer Hospital & Institute
    • Contact: Principal Investigator
  • Shenzhen, China, 518116
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
    • Contact: Principal Investigator
  • Shenzhen, China, 518053
    • Recruiting
    • The University of Hong Kong- Shenzhen Hospital
    • Contact: Principal Investigator
  • Taiyuan, China, 030000
    • Recruiting
    • Shanxi Provincial Cancer Hospital
    • Contact: Principal Investigator
  • Tangshan, China, 063001
    • Recruiting
    • Tangshan People's Hospital
    • Contact: Principal Investigator
  • Tianjin, China, 300308
    • Recruiting
    • Tianjin Cancer Hospital Airport Hospital
    • Contact: Principal Investigator
  • Weifang, China, 261044
    • Recruiting
    • Weifang People's Hospital
    • Contact: Principal Investigator
  • Wenzhou, China, 325000
    • Recruiting
    • Wenzhou Central Hospital
    • Contact: Principal Investigator
  • Xi'an, China, 710061
    • Recruiting
    • The First Affiliated Hospital of Xi'an Jiaotong University
    • Contact: Principal Investigator
  • Xi'an, China, 710004
    • Recruiting
    • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Contact: Principal Investigator
  • Xi'an, China, 710119
    • Recruiting
    • Xi'an International Medical Center Hospital
    • Contact: Principal Investigator
  • Xiamen, China, 361003
    • Recruiting
    • The First Affilital of Xiamen University
    • Contact: Principal Investigator
  • Xinxiang, China, 453100
    • Recruiting
    • The First Affiliated Hospital of Xinxiang Medical University
    • Contact: Principal Investigator
  • Xuzhou, China, 221004
    • Recruiting
    • The Affiliated Hospital of Xuzhou Medical University
    • Contact: Principal Investigator
  • Yinchuan, China, 750003
    • Withdrawn
    • General Hospital of Ningxia Medical University
  • Zengzhou, China, 450003
    • Recruiting
    • Henan Cancer Hospital
    • Contact: Principal Investigator
  • Zhengzhou, China, 463599
    • Recruiting
    • Henan Provincial People's Hospital
    • Contact: Principal Investigator
  • Zhengzhou, China, 100142
    • Withdrawn
    • The First Affiliated Hospital of Zhengzhou University
  • Zhongshan, China, 528403
    • Recruiting
    • Zhongshan City People's Hospital
    • Contact: Principal Investigator
  • Zhuhai, China, 519000
    • Recruiting
    • The Fifth Affiliated Hospital, Sun Yat-sen University
    • Contact: Principal Investigator
  • Ürümqi, China, 830011
    • Recruiting
    • Affiliated Cancer Hospital of Xinjiang Medical University
    • Contact: Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.	Drug: Trastuzumab deruxtecan; Intravenous infusion; Other Names: T-DXd
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.	Drug: Trastuzumab deruxtecan; Intravenous infusion; Other Names: T-DXd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Time to next treatment or death from index date will be assessed.	Assessed over a 36-month period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Duration of treatment is defined as the length of time a patient is treated.	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	Time to discontinuation is defined as time from index date to the earliest date of T-DXd discontinuation, or date of death.	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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Investigators: Study Director: Director, Daiichi Sankyo China

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer; Advanced cancer; HER2-positive breast cancer; T-DXd; Trastuzumab deruxtecan; HER2-low breast cancer; Unresectable or metastatic breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; trastuzumab deruxtecan
• Other Study ID Numbers: DSCN-EHT-NIS-BC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No