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

April 17, 2024 updated by: Daiichi Sankyo

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daiichi Sankyo Contact for Clinical Trial Information
  • Phone Number: 9089926400
  • Email: CTRinfo@dsi.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
          • Principal Investigator
      • Beijing, China, 100034
        • Not yet recruiting
        • Peking University first hospital
        • Contact:
          • Principal Investigator
      • Beijing, China, 100029
        • Not yet recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Principal Investigator
      • Beijing, China, 100144
        • Not yet recruiting
        • Peking University Shougang Hospital
        • Contact:
          • Principal Investigator
      • Chengdu, China, 610041
        • Not yet recruiting
        • Sichuan Cancer hospital
        • Contact:
          • Principal Investigator
      • Chengdu, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Principal Investigator
      • Chongqing, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Principal Investigator
      • Chongqing, China, 400038
        • Not yet recruiting
        • The Southwest hospital of AMU
        • Contact:
          • Principal Investigator
      • Dalian, China, 116001
        • Not yet recruiting
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
          • Principal Investigator
      • Foshan, China, 528000
        • Not yet recruiting
        • The First People's Hospital of Foshan
      • Fuzhou, China, 350000
        • Not yet recruiting
        • Fujian cancer hospital
        • Contact:
          • Principal Investigator
      • Guangzhou, China, 510060
        • Not yet recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
          • Principal Investigator
      • Guangzhou, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
          • Principal Investigator
      • Guangzhou, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
      • Guangzhou, China, 511400
        • Not yet recruiting
        • Guangdong Women and Children Hospital
        • Contact:
          • Principal Investigator
      • Haikou, China, 570311
        • Recruiting
        • Hainan Cancer Hospital
        • Contact:
          • Principal Investigator
      • Hangzhou, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Principal Investigator
      • Hangzhou, China, 310009
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Principal Investigator
      • Hangzhou, China, 325088
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Principal Investigator
      • Harbin, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Principal Investigator
      • Hefei, China, 230022
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Principal Investigator
      • Hefei, China, 230031
        • Not yet recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
          • Principal Investigator
      • Jiamusi, China, 154007
        • Recruiting
        • Jiamusi Cancer Hospital
        • Contact:
          • Principal Investigator
      • Kunming, China, 650118
        • Not yet recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Principal Investigator
      • Lanzhou, China, 730030
        • Not yet recruiting
        • Lanzhou University First Hospital
        • Contact:
          • Principal Investigator
      • Luoyang, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
          • Principal Investigator
      • Nanchang, China, 330000
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Principal Investigator
      • Nanchang, China, 330000
        • Recruiting
        • Nanchang Third Hospital
      • Nanjing, China, 210008
        • Not yet recruiting
        • Nanjing Drum Tower hospital
        • Contact:
          • Principal Investigator
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Principal Investigator
      • Nanning, China, 541000
        • Not yet 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
        • Not yet recruiting
        • Ningbo No.2 Hospital
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200080
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200000
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200072
        • Not yet recruiting
        • Tenth People's Hospital of Tongji University
        • Contact:
          • Principal Investigator
      • Shanghai, China, 200433
        • Not yet recruiting
        • Changhai Hospital
        • Contact:
          • Principal Investigator
      • Shenzhen, China, 518116
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
        • Contact:
          • Principal Investigator
      • Taiyuan, China, 030000
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Principal Investigator
      • Wulumuqi, China, 830011
        • Not yet recruiting
        • Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
          • Principal Investigator
      • Xi'an, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'An JiaoTong University
        • Contact:
          • Principal Investigator
      • Xiamen, China, 361003
        • Not yet recruiting
        • The First Affilital of Xiamen University
        • Contact:
          • Principal Investigator
      • Yancheng, China, 224001
        • Not yet recruiting
        • Yancheng No.1 People's Hospital
        • Contact:
          • Principal Investigator
      • Yinchuan, China, 750003
        • Not yet recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Principal Investigator
      • Zengzhou, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • Principal Investigator
      • Zhengzhou, China, 100142
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Principal Investigator
      • Zhengzhou, China, 463599
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Principal Investigator
      • Zhuhai, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital，Sun Yat-sen University
        • Contact:
          • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 Frame: Assessed over a 36-month period
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
Time Frame: Assessed over a 36-month period
Assessed over a 36-month period
Duration of Treatment (DoT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Time Frame: Assessed over a 36-month period
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
Time Frame: Assessed over a 36-month period
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
Time Frame: Assessed over a 36-month period
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
Time Frame: Assessed over a 36-month period
Assessed over a 36-month period
Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management
Time Frame: Assessed over a 36-month period
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 Frame: 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.
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
Time Frame: Baseline up to 1 month post-T-DXd treatment
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
Time Frame: Baseline up to 1 month post-T-DXd treatment
Baseline up to 1 month post-T-DXd treatment
Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data
Time Frame: Baseline up to 1 month post-T-DXd treatment
Baseline up to 1 month post-T-DXd treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Investigators

  • Study Director: Director, Daiichi Sankyo China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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