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

NCT06210776 | Recruiting FDA Drug

• 1 other identifier: DSCN-EHT-NIS-BC002
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 54

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.

Conditions

HER2-low Breast Cancer; Breast Cancer; Advanced Cancer; HER2-positive Breast Cancer

Keywords

HER2-positive breast cancer; HER2-low breast cancer; Breast cancer; Advanced cancer; Unresectable or metastatic breast cancer; Trastuzumab deruxtecan; T-DXd

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

Cohort A

Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.

Drug: Trastuzumab deruxtecan

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

Interventions

Trastuzumab deruxtecan DRUG

Intravenous infusion

Also known as: T-DXd

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (54)

China-Japan Friendship Hospital

Beijing, 100029, China

RECRUITING

Peking University First Hospital

Beijing, 100034, China

RECRUITING

The Fifth Medical Center of the Chinese PLA General Hospital

Beijing, 100039, China

WITHDRAWN

Peking University Shougang Hospital

Beijing, 100144, China

RECRUITING

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Beijing GoBroad Hospital

Beijing, 102206, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, 610041, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, 610072, China

RECRUITING

Affiliated Zhongshan Hospital of Dalian University

Dalian, 116001, China

RECRUITING

The First People's Hospital of Foshan

Foshan, 528000, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, 350000, China

RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, 510060, China

WITHDRAWN

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, 510120, China

RECRUITING

Hainan Cancer Hospital

Haikou, 570311, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310009, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, 310022, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, 150081, China

RECRUITING

Anhui Provincial Cancer Hospital

Hefei, 230031, China

WITHDRAWN

Jiamusi Cancer Hospital

Jiamusi, 154007, China

RECRUITING

Yunnan Cancer Hospital

Kunming, 650118, China

WITHDRAWN

The First People's Hospital of Lianyungang

Lianyungang, 222002, China

RECRUITING

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, 450052, China

ACTIVE NOT RECRUITING

Jiangxi Cancer Hospital

Nanchang, 330000, China

RECRUITING

Nanchang Third Hospital

Nanchang, 330000, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, 210008, China

RECRUITING

Jiangsu Province Hospital

Nanjing, 210029, China

RECRUITING

The Peoples of Guangxi Zhuang Autonomous Region

Nanning, 541000, China

RECRUITING

Affiliated Hospital Of Nantong University

Nantong, 226001, China

RECRUITING

Ningbo No.2 Hospital

Ningbo, 315010, China

WITHDRAWN

Qingdao Central Hospital

Qingdao, 266042, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 200000, China

RECRUITING

Changhai Hospital

Shanghai, 200433, China

RECRUITING

Cancer Hospital of Shantou University Medical College

Shantou, 515031, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, 110000, China

RECRUITING

The University of Hong Kong- Shenzhen Hospital

Shenzhen, 518053, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, 518116, China

RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, 030000, China

RECRUITING

Tangshan People's Hospital

Tangshan, 063001, China

RECRUITING

Tianjin Cancer Hospital Airport Hospital

Tianjin, 300308, China

RECRUITING

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, 830011, China

RECRUITING

Weifang People's Hospital

Weifang, 261044, China

RECRUITING

Wenzhou Central Hospital

Wenzhou, 325000, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061, China

RECRUITING

Xi'an International Medical Center Hospital

Xi'an, 710119, China

RECRUITING

The First Affilital of Xiamen University

Xiamen, 361003, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, 453100, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, 221004, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, 750003, China

WITHDRAWN

Henan Cancer Hospital

Zengzhou, 450003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 100142, China

WITHDRAWN

Henan Provincial People's Hospital

Zhengzhou, 463599, China

RECRUITING

Zhongshan City People's Hospital

Zhongshan, 528403, China

RECRUITING

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, 519000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Director

  Daiichi Sankyo China

  STUDY DIRECTOR

Central Study Contacts

Daiichi Sankyo China

CONTACT

0086-021-60397406; yu.huan.m8@daiichisankyo.com.cn

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

9089926400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (54)