A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
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.
Eligibility criteria
Qualifiers
≥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.
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Trastuzumab deruxtecan
Treatment groups
800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov