An observational study in HER2-positive Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Fudan University · Observational
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.
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.
Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: Through study completion, an average of 1 year.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year.
Demographics characteristics
Demographics characteristics: include age, height in meters, weight in kilograms, and BMI. The age of the patients will be measured in years, height will be documented by meters, weight by kilograms, and BMI by kg/m\^2
Time frame: Through study completion, an average of 1 year.
Socio-economic status
Socio-economic status: include education, and marital status.
Time frame: Through study completion, an average of 1 year.
Clinical characteristics
Clinical characteristics: include pathological TNM stage, histological grade, ER/PR status, HER2 Status, Ki-67 index, pathological subtype, WHO Performance Status score at T0, and menopausal status. TNM stage will be recorded according to the pathology results, histological grade will be documented by WHO grade I to III, ER/PR status will be measured with immumohistochemical staining. WHO Performance Status score will be classified into 0-4 levels. 0: able to carry out all normal activity without restriction. 1. restricted in strenuous activity but ambulatory and able to carry out light work. 2. ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3. symptomatic and in a chair or in bed for greater than 50% of the day but not bedridden. 4. completely disabled; cannot carry out any self-care; totally confined to bed or chair.
Time frame: Through study completion, an average of 1 year.
Treatment sequence (neoadjuvant vs adjuvant)
Patients receiving neoadjuvant or adjuvant treatments in fact.
Time frame: Through study completion, an average of 1 year.
Clinical treatment
Clinical treatment: include breast surgery (Mastectomy vs. Conservative surgery), axillary surgery (axillary dissection vs sentinel node biopsy), radiotherapy, anti-HER2 antibody therapy (pertuzumab vs. trastuzumab), anti-HER2 TKI therapy (yes vs. no), chemotherapy (yes vs. no).
Time frame: Through study completion, an average of 1 year.
Plan to share: No
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Fudan University