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

Recruiting

• Conditions: HER2-positive Breast Cancer; HER2-low Breast Cancer; Breast Cancer; Advanced Cancer
• Interventions: Drug: Trastuzumab deruxtecan

• Registration Number: NCT06210776
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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.

Detailed Description

The primary objective of the study is to evaluate real-world time to next treatment or date of death from index date (T-DXd treatment initiation date)(rwTTNT) in each cohort. The secondary objectives of this study are to describe treatment patterns in eligible patients with HER2+ or HER2-low unresectable or mBC who are newly initiating T-DXd in a real-world setting, to describe demographic and clinical characteristics, to assess the safety and tolerability through the collection of physician-reported SEIs, to characterize the management of SEIs, to evaluate real-world time to treatment discontinuation (rwTTD) of T-DXd, and to evaluate patient-reported tolerability.

This decision to treat the patient with T-DXd will be made prior to, and independent of, their participation in this study. Eligible patients willing to participate will be enrolled consecutively in the study and followed up from index date (T-DXd treatment initiation date) until end of study, death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first.

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study Start: 2024-01-15
• Study First Posted: 2024-01-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Trastuzumab deruxtecan	Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.
Cohort B	Trastuzumab deruxtecan	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 Measures

Name	Time	Method
Real World Time to Next Treatment (rwTTNT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Assessed over a 36-month period	Time to next treatment or death from index date will be assessed.

Secondary Outcome Measures

Name	Time	Method
Duration of Treatment (DoT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Assessed over a 36-month period	Duration of treatment is defined as the length of time a patient is treated.
Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Assessed over a 36-month period
Percentage of Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinical Characteristics	Assessed over a 36-month period
Number of Participants Reporting Physician-reported Safety Events of Interest (SEI) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Assessed over a 36-month period
Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management	Assessed over a 36-month period
Real-world Time to Discontinuation (rwTTD) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Assessed over a 36-month period	Time to discontinuation is defined as time from index date to the earliest date of T-DXd discontinuation, or date of death.
Change in Patient's Global Impression of Treatment Tolerability in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Baseline up to 1 month post-T-DXd treatment
Number of Participants Reporting Symptom Items From National Cancer Institute Patient Reported Outcome Common Terminology Criteria for Adverse Events	Baseline up to 1 month post-T-DXd treatment
Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data	Baseline up to 1 month post-T-DXd treatment
Change in T-DXd Dosing in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer	Assessed over a 36-month period

Trial Locations

Locations (54)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China

The Fifth Medical Center of the Chinese PLA General Hospital; 🇨🇳 Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Beijing GoBroad Hospital; 🇨🇳 Beijing, China

Sichuan Cancer Hospital; 🇨🇳 Chengdu, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

Affiliated Zhongshan Hospital of Dalian University; 🇨🇳 Dalian, China

The First People's Hospital of Foshan; 🇨🇳 Foshan, China

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