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

Launched by DAIICHI SANKYO · Jan 8, 2024

Keywords

ClinConnect Summary

The REFRESH clinical trial is studying the effectiveness of a medication called Trastuzumab Deruxtecan (or T-DXd) for patients with specific types of breast cancer. This study focuses on patients with unresectable or metastatic HER2-positive breast cancer, which means their cancer is advanced and cannot be surgically removed, as well as those with HER2-low breast cancer. Both groups of patients must have already received previous treatments for their cancer. The goal is to gather real-world data about how well this treatment works and how patients feel about their experience.

To be eligible for this study, participants must be at least 18 years old and have confirmed advanced breast cancer. They should meet specific criteria regarding their HER2 status and treatment history, and they need to be able to provide informed consent. Participants will be asked to complete questionnaires about their health and treatment experience but can still join the study even if they cannot complete these questionnaires. The study is currently recruiting participants, and it is important to know that individuals who are pregnant, breastfeeding, or have certain health conditions may not be able to participate.

Gender

ALL

Eligibility criteria

• 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.