HER2-positive Breast CancerNCT06210776
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
An observational study of HER2-positive Breast Cancer and HER2-low Breast Cancer, run by Daiichi Sankyo at 54 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, HER2-low Breast Cancer, Breast Cancer
- What is being tested?
- Trastuzumab deruxtecan
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 54 sitesChina
- Study dates
- 15 Jan 2024to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 800 eligible subjects with HER2+ or HER2-low unresectable or mBC will be enrolled in this study.
Patients must meet all of the following inclusion criteria to be eligible for the study:
- ≥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. 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.
- 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.
- Capable of providing informed consent.
- 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:
- Pregnancy or breastfeeding.
- Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
- Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.
- Patients who have been judged by the investigator to be unfit to participate the study.
Trial locations and contacts
54 sites in 1 country. Contact the study team or a site near you to ask about taking part.
54 sites in 1 country
China54 sites, 46 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Principal Investigator
- Recruiting
Peking University First Hospital
Beijing, 100034
Principal Investigator
- Withdrawn
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, 100039
- Recruiting
Peking University Shougang Hospital
Beijing, 100144
Principal Investigator
- Recruiting
Peking University Third Hospital
Beijing, 100191
Principal Investigator
- Recruiting
Beijing GoBroad Hospital
Beijing, 102206
Principal Investigator
- Recruiting
Sichuan Cancer Hospital
Chengdu, 610041
Principal Investigator
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Principal Investigator
- Recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, 116001
Principal Investigator
- Recruiting
The First People's Hospital of Foshan
Foshan, 528000
Principal Investigator
- Recruiting
Fujian Cancer Hospital
Fuzhou, 350000
Principal Investigator
- Withdrawn
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, 510060
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120
Principal Investigator
- Recruiting
Hainan Cancer Hospital
Haikou, 570311
Principal Investigator
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
Principal Investigator
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
Principal Investigator
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
Principal Investigator
- Withdrawn
Anhui Provincial Cancer Hospital
Hefei, 230031
- Recruiting
Jiamusi Cancer Hospital
Jiamusi, 154007
Principal Investigator
- Withdrawn
Yunnan Cancer Hospital
Kunming, 650118
- Recruiting
The First People's Hospital of Lianyungang
Lianyungang, 222002
Principal Investigator
- Active, not recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, 450052
- Recruiting
Jiangxi Cancer Hospital
Nanchang, 330000
Principal Investigator
- Recruiting
Nanchang Third Hospital
Nanchang, 330000
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Principal Investigator
- Recruiting
Jiangsu Province Hospital
Nanjing, 210029
Principal Investigator
- Recruiting
The Peoples of Guangxi Zhuang Autonomous Region
Nanning, 541000
Principal Investigator
- Recruiting
Affiliated Hospital Of Nantong University
Nantong, 226001
Principal Investigator
- Withdrawn
Ningbo No.2 Hospital
Ningbo, 315010
- Recruiting
Qingdao Central Hospital
Qingdao, 266042
Principal Investigator
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200000
Principal Investigator
- Recruiting
Changhai Hospital
Shanghai, 200433
Principal Investigator
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, 515031
Principal Investigator
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, 110000
Principal Investigator
- Recruiting
The University of Hong Kong- Shenzhen Hospital
Shenzhen, 518053
Principal Investigator
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, 518116
Principal Investigator
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, 030000
Principal Investigator
- Recruiting
Tangshan People's Hospital
Tangshan, 063001
Principal Investigator
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, 300308
Principal Investigator
- Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, 830011
Principal Investigator
- Recruiting
Weifang People's Hospital
Weifang, 261044
Principal Investigator
- Recruiting
Wenzhou Central Hospital
Wenzhou, 325000
Principal Investigator
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004
Principal Investigator
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Principal Investigator
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, 710119
Principal Investigator
- Recruiting
The First Affilital of Xiamen University
Xiamen, 361003
Principal Investigator
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, 453100
Principal Investigator
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221004
Principal Investigator
- Withdrawn
General Hospital of Ningxia Medical University
Yinchuan, 750003
- Recruiting
Henan Cancer Hospital
Zengzhou, 450003
Principal Investigator
- Withdrawn
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 100142
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, 463599
Principal Investigator
- Recruiting
Zhongshan City People's Hospital
Zhongshan, 528403
Principal Investigator
- Recruiting
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, 519000
Principal Investigator
About this study
Official title: A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
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.
Read the 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.
- Being tested
- Trastuzumab deruxtecan
- Keywords
- HER2-positive breast cancer, HER2-low breast cancer, Breast cancer, Advanced cancer, Unresectable or metastatic breast cancer, Trastuzumab deruxtecan, T-DXd
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Also called T-DXd
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens. Receives: Drug: Trastuzumab deruxtecan | |
| 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. Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed over a 36-month period
Secondary outcomes (10)
Change in T-DXd Dosing in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Measured: Assessed over a 36-month period
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.
Measured: Assessed over a 36-month period
Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Measured: 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
Measured: 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
Measured: Assessed over a 36-month period
Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management
Measured: 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
Time to discontinuation is defined as time from index date to the earliest date of T-DXd discontinuation, or date of death.
Measured: Assessed over a 36-month period
Change in Patient's Global Impression of Treatment Tolerability in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Measured: 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
Measured: Baseline up to 1 month post-T-DXd treatment
Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data
Measured: Baseline up to 1 month post-T-DXd treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start15 Jan 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Study director, Daiichi Sankyo China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210776
- Sponsor's protocol ID
- DSCN-EHT-NIS-BC002
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
- ClinicalTrials.gov ID
- NCT06210776
- Acronym / sponsor ID
- DSCN-EHT-NIS-BC002
- Keywords
- HER2-positive breast cancer, HER2-low breast cancer, Breast cancer, Advanced cancer, Unresectable or metastatic breast cancer, Trastuzumab deruxtecan, T-DXd
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Trastuzumab deruxtecanPatients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens. |
| Cohort B | – | Drug: Trastuzumab deruxtecanPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 800 eligible subjects with HER2+ or HER2-low unresectable or mBC will be enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab deruxtecanAlso: T-DXdIntravenous infusion | Drug | Cohort A, Cohort B |
Primary outcome
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
Time to next treatment or death from index date will be assessed.
10 secondary outcomes
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 period
Duration of Treatment (DoT) in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Time frame: Assessed over a 36-month period
Change in Dose Amendment in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Time frame: 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
Time frame: 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
Time frame: Assessed over a 36-month period
Number of Participants Reporting Prophylactic and Reactive Treatment for SEI Management
Time frame: 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
Time frame: Assessed over a 36-month period
Change in Patient's Global Impression of Treatment Tolerability in Participants With HER2-positive and HER2-low Unresectable or Metastatic Breast Cancer
Time frame: 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
Time frame: Baseline up to 1 month post-T-DXd treatment
Number of Participants Reporting Nausea and Vomiting Based on Symptom Diary Data
Time frame: Baseline up to 1 month post-T-DXd treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Director study director
Daiichi Sankyo China
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer and HER2-low Breast Cancer, run by Daiichi Sankyo at 54 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daiichi Sankyo China (0086-021-60397406, yu.huan.m8@daiichisankyo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.