HER2-positive Breast CancerNCT06161922
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
An observational study of HER2-positive Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in Chinese HER2+ early breast cancer patients undergoing (neo) adjuvant anti-HER2 based therapy and describe changes over time, from baseline to 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2023to 8 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population is Chinese HER2+ early breast cancer patients receiving (neo) adjuvant anti-HER2 based therapy. Patients who are eligible for (neo) adjuvant anti-HER2 based therapy will enroll in this study.
Who may be able to join
- Patients aged ≥18 years;
- Women;
- Have signed the informed consent form as per local regulations;
- Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy;
- Be able to comply with the follow-up visits, assessments, answering questionnaires.
Who cannot join
- Metastatic breast cancer;
- Prior systemic treatment for any malignancy;
- Active secondary cancer requiring anti-HER2 therapy;
- Vulnerable populations [e.g., decisional impaired (cognitive, psychiatric), terminally ill, prisoners], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent;
- Men.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Patient-Reported Outcomes in Chinese Her2+ Early Breast Cancer Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
This is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in Chinese HER2+ early breast cancer patients undergoing (neo) adjuvant anti-HER2 based therapy and describe changes over time, from baseline to 12 months.
Read the detailed description
This is a non-interventional observational, multi-center cohort study with primary prospective data collection. This study will be conducted at approximately 9 sites in China.
The study population is Chinese HER2+ early breast cancer patients receiving (neo) adjuvant anti-HER2 based therapy.
Patients who are eligible for (neo) adjuvant anti-HER2 based therapy will enroll in this study.
Treatment choice in this non-interventional study will be at the discretion of the treating physician as per CACA-CBCS guidelines.
Participants are longitudinally assessed at baseline (T0, prior to treatment), mid-chemotherapy (T1, after 2 cycles), 1-month post-chemotherapy (T2) and at 12-month follow-up (T3).
The PRO instruments will be captured by electronic devices through WeChat mini-program which are input by patients, before or after their clinic visit but before administration of anti-HER2 therapy. Paper questionnaires will be available only as a last option if the electronic devices cannot be used for any reason (such as issues with internet access or if the device is not working). Oncology staff provided no assistance with filling in the questionnaires, but a prerecorded video will provide a detailed explanation of the questionnaires before the ePRO questionnaires. The PROs data will be restored centrally at the server of the leading site.
The usage of PROs is considered non-interventional according to local regulation. PRO measures include EORTC QLQ-C30, PDQ-5 (cognitive), PHQ-9 (depression), GAD-7 (anxiety) and Insomnia Severity Index (ISI).
Patient satisfaction for subcutaneous injection will be assessed using TASQ-SC at T3.
- Conditions
- HER2-positive Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-C30 Summary Score
EORTC QLQ C30 questionnaire to evaluate quality of life. The EORTC QLQ-C30 is a 30-item questionnaire consisting of five multi-item functional subscales (physical, role, cognitive, emotional, and social), three multi-item symptom subscales (fatigue, pain, nausea and vomiting), and six single-item symptom subscales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), in addition to a two-item subscale for global health status. After linear transformation, all subscales range in score from 0-100.
The EORTC QLQ-C30 summary score was calculated from the mean of 13 component subscales, excluding global health status and financial difficulties, if all 13 included subscales are non-missing. Prior to calculating the mean, symptom subscales were reversed to obtain a consistent direction for all subscales. Therefore, a higher summary score indicates higher HRQoL.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (6)
EORTC QLQ-C30
Beyond the summary score, the 15 specific subscales of EORTC QLQ-C30 were analyzed to identify changes in quality of life. For functional subscales and global health status, higher scores reflect superior health status, whereas for symptom subscales, higher scores reflect greater symptom severity.
Measured: Through study completion, an average of 1 year.
PDQ-5 score
Perceived Deficits Questionnaire to capture decline in cognitive function. Participants report the extent to which they have experienced those symptoms or problems during the past week. Each of the symptoms or problems is indicated with four extents, including " never" for 0 score, "rarely" for 1 score, " sometimes" for 2 score and " often" for 3 score, "almost always"for 4 score. A higher score indicated a more serious decline in cognitive function.
Measured: Through study completion, an average of 1 year.
PHQ-9 score
Patient Health Questionnaire to measure the severity of depression. Participants report the extent to which they have experienced those symptoms or problems during the past week. Each of the symptoms or problems is indicated with four extents, including "not at all" for 0 score," several days " for 1 score, " more than half the days " for 2 score and " nearly every day " for 3 score. A higher score indicated a worse state.
Measured: Through study completion, an average of 1 year.
GAD-7 score
GAD-7 (Generalized Anxiety Disorder-7) questionnaire to evaluate anxiety: includes scores for all 7 items and date of self-assessment at T0 to T3.
Participants report the extent to which they have experienced those symptoms or problems during the past week. Each of the symptoms or problems is indicated with four extents, including "not at all" for 0 score," several days " for 1 score, " more than h
Measured: Through study completion, an average of 1 year.
ISI score
ISI (Insomnia Severity Index) questionnaire to evaluate Insomnia Severity: includes scores for all 7 items and date of self-assessment .
Participants report the extent to which they have experienced those symptoms or problems during the past two weeks. Each of the symptoms or problems is indicated with four extents, the total value range from 0 to 21, and higher scores mean a more severe insomnia.
Measured: Through study completion, an average of 1 year.
TASQ-SC score
Therapy Administration Satisfaction Questionnaire is a 12-item questionnaire measuring the impact of each mode of treatment administration on five domains: physical impact, psychological impact, impact on activities of daily living, convenience, and satisfaction. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start7 Nov 2023
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
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 Fudan UniversityThe 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keda Yu, Fudan University
- Investigators
- Keda Yu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161922
- Sponsor's protocol ID
- ML44677
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Patient-Reported Outcomes in Chinese Her2+ Early Breast Cancer Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
- ClinicalTrials.gov ID
- NCT06161922
- Acronym / sponsor ID
- ML44677
- Conditions
- HER2-positive Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 8 Dec 2023 (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 is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in Chinese HER2+ early breast cancer patients undergoing (neo) adjuvant anti-HER2 based therapy and describe changes over time, from baseline to 12 months.
Detailed description
This is a non-interventional observational, multi-center cohort study with primary prospective data collection. This study will be conducted at approximately 9 sites in China.
The study population is Chinese HER2+ early breast cancer patients receiving (neo) adjuvant anti-HER2 based therapy.
Patients who are eligible for (neo) adjuvant anti-HER2 based therapy will enroll in this study.
Treatment choice in this non-interventional study will be at the discretion of the treating physician as per CACA-CBCS guidelines.
Participants are longitudinally assessed at baseline (T0, prior to treatment), mid-chemotherapy (T1, after 2 cycles), 1-month post-chemotherapy (T2) and at 12-month follow-up (T3).
The PRO instruments will be captured by electronic devices through WeChat mini-program which are input by patients, before or after their clinic visit but before administration of anti-HER2 therapy. Paper questionnaires will be available only as a last option if the electronic devices cannot be used for any reason (such as issues with internet access or if the device is not working). Oncology staff provided no assistance with filling in the questionnaires, but a prerecorded video will provide a detailed explanation of the questionnaires before the ePRO questionnaires. The PROs data will be restored centrally at the server of the leading site.
The usage of PROs is considered non-interventional according to local regulation. PRO measures include EORTC QLQ-C30, PDQ-5 (cognitive), PHQ-9 (depression), GAD-7 (anxiety) and Insomnia Severity Index (ISI).
Patient satisfaction for subcutaneous injection will be assessed using TASQ-SC at T3.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is Chinese HER2+ early breast cancer patients receiving (neo) adjuvant anti-HER2 based therapy. Patients who are eligible for (neo) adjuvant anti-HER2 based therapy will enroll in this study.
Key inclusion criteria (5 listed)
- Patients aged ≥18 years;
- Women;
- Have signed the informed consent form as per local regulations;
- Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy;
- Be able to comply with the follow-up visits, assessments, answering questionnaires.
Key exclusion criteria (5 listed)
- Metastatic breast cancer;
- Prior systemic treatment for any malignancy;
- Active secondary cancer requiring anti-HER2 therapy;
- Vulnerable populations [e.g., decisional impaired (cognitive, psychiatric), terminally ill, prisoners], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent;
- Men.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EORTC QLQ-C30 Summary Score
Time frame: Through study completion, an average of 1 year.
EORTC QLQ C30 questionnaire to evaluate quality of life. The EORTC QLQ-C30 is a 30-item questionnaire consisting of five multi-item functional subscales (physical, role, cognitive, emotional, and social), three multi-item symptom subscales (fatigue, pain, nausea and vomiting), and six single-item symptom subscales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), in addition to a two-item subscale for global health status. After linear transformation, all subscales range in score from 0-100. The EORTC QLQ-C30 summary score was calculated from the mean of 13 component subscales, excluding global health status and financial difficulties, if all 13 included subscales are non-missing. Prior to calculating the mean, symptom subscales were reversed to obtain a consistent direction for all subscales. Therefore, a higher summary score indicates higher HRQoL.
6 secondary outcomes
EORTC QLQ-C30
Time frame: Through study completion, an average of 1 year.
PDQ-5 score
Time frame: Through study completion, an average of 1 year.
PHQ-9 score
Time frame: Through study completion, an average of 1 year.
GAD-7 score
Time frame: Through study completion, an average of 1 year.
ISI score
Time frame: Through study completion, an average of 1 year.
TASQ-SC score
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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. This study is not recruiting at the moment.
Keda Yu, MD, PhD principal investigator
Fudan University
1 site 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, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-C30 Summary Score (time frame: Through study completion, an average of 1 year.). 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 7 Jul 2026.