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

Sponsor
Daiichi Sankyo
Study ID
NCT06210776
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Jan 15, 2024
Status verified
Jan 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Cohort A
    Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.
  • Arm: Cohort B
    Patients with unresectable or metastatic HER2-low breast cancer patients 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.

Primary Outcome Measure

Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer [ Time Frame: Assessed over a 36-month period ]

Central Contacts

Related Studies