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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210776
• Other study ID #: DSCN-EHT-NIS-BC002
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: April 2024
• Source: Daiichi Sankyo
• Contact: Daiichi Sankyo China
• Phone: 0086-021-60397406
• Email: yu.huan.m8[@]daiichisankyo.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• Trastuzumab deruxtecan
Intravenous infusion

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Shougang Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Sichuan Cancer Hospital	Chengdu
China	Sichuan Provincial People's Hospital	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	The Southwest Hospital of AMU	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	Dalian
China	The First People's Hospital of Foshan	Foshan
China	Fujian Cancer Hospital	Fuzhou
China	Guangdong Women and Children Hospital	Guangzhou
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou
China	Sun Yat-sen University Cancer Center	Guangzhou
China	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou
China	Hainan Cancer Hospital	Haikou
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	Anhui Provincial Cancer Hospital	Hefei
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	Jiamusi Cancer Hospital	Jiamusi
China	Yunnan cancer hospital	Kunming
China	Lanzhou University First Hospital	Lanzhou
China	The First Affiliated Hospital of Henan University of Science & Technology	Luoyang
China	Jiangxi Cancer Hospital	Nanchang
China	Nanchang Third Hospital	Nanchang
China	Jiangsu Province Hospital	Nanjing
China	Nanjing Drum Tower 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	Changhai Hospital	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School Of Medicine	Shanghai
China	Shanghai General Hospital	Shanghai
China	Tenth People's Hospital of Tongji University	Shanghai
China	Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center	Shenzhen
China	Shanxi Provincial Cancer Hospital	Taiyuan
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	Yancheng No.1 People's Hospital	Yancheng
China	General Hospital of Ningxia Medical University	Yinchuan
China	Henan Cancer Hospital	Zengzhou
China	Henan Provincial People's Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	The Fifth Affiliated Hospital,Sun Yat-sen University	Zhuhai

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in T-DXd Dosing in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer		Assessed over a 36-month period
Secondary	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
Secondary	Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer		Assessed over a 36-month period
Secondary	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
Secondary	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
Secondary	Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management		Assessed over a 36-month period
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data		Baseline up to 1 month post-T-DXd treatment