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
This trial does not accept healthy volunteersQualifiers
≥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 population
Approximately 800 eligible subjects with HER2+ or HER2-low unresectable or mBC will be enrolled in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Trastuzumab deruxtecan
DrugIntravenous infusion
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Cohort A1 intervention
Group B: Cohort B1 intervention
Trial outcomes
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.
Time frame
Assessed over a 36-month periodSecondary outcomes
1
Change in T-DXd Dosing in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Time frame
Assessed over a 36-month period2
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.
Time frame
Assessed over a 36-month period3
Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Time frame
Assessed over a 36-month period4
Percentage of Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinical Characteristics
Time frame
Assessed over a 36-month periodSponsors and contacts
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Source ClinicalTrials.gov