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Assessing Trastuzumab Deruxtecan in Chinese Patients with HER2-positive and HER2-low Breast Cancer

A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

Observational Daiichi Sankyo · NCT06210776

This study is testing how well Trastuzumab Deruxtecan works for Chinese patients with advanced HER2-positive or HER2-low breast cancer who have already tried other treatments.

Quick facts

Study typeObservational
Enrollment800 (estimated)
Ages18 Years and up
SexAll
SponsorDaiichi Sankyo Industry-sponsored
Drugs / interventionschemotherapy
Locations54 sites (Beijing and 53 other locations)
Trial IDNCT06210776 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect real-world clinical and patient-reported outcome data from Chinese patients with unresectable or metastatic HER2-positive or HER2-low breast cancer who have received prior anti-HER2 treatments. The primary goal is to evaluate the time to next treatment or date of death following the initiation of Trastuzumab Deruxtecan (T-DXd). Secondary objectives include analyzing treatment patterns, demographic and clinical characteristics, safety and tolerability, and time to treatment discontinuation. Patients will be followed from the initiation of T-DXd until the end of the study or until they withdraw consent or are lost to follow-up.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic HER2-positive or HER2-low breast cancer who have received prior systemic therapy.

Not a fit: Patients with early-stage breast cancer or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Trastuzumab Deruxtecan for patients with advanced HER2-positive and HER2-low breast cancer.

How similar studies have performed: Other studies have shown promise in evaluating treatments for HER2-positive breast cancer, but this specific observational approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Beijing and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2-positive Breast CancerHER2-low Breast CancerBreast CancerAdvanced CancerHER2-positive breast cancerHER2-low breast cancerBreast cancerAdvanced cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.