Status:
RECRUITING
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Lead Sponsor:
Daiichi Sankyo
Conditions:
HER2-positive Breast Cancer
HER2-low Breast Cancer
Eligibility:
All Genders
18+ years
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...
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 ...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria to be eligible for the study:
- ≥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.
Exclusion
Key Trial Info
Start Date :
January 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06210776
Start Date
January 15 2024
End Date
March 1 2028
Last Update
November 26 2025
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
1
China-Japan Friendship Hospital
Beijing, China, 100029
2
Peking University First Hospital
Beijing, China, 100034
3
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, China, 100039
4
Peking University Shougang Hospital
Beijing, China, 100144