Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy

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.

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.

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.

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.

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

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.

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.

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

Socio-economic status: include education, and marital status.

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.

• restricted in strenuous activity but ambulatory and able to carry out light work.
• ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
• symptomatic and in a chair or in bed for greater than 50% of the day but not bedridden.
• completely disabled; cannot carry out any self-care; totally confined to bed or chair.

Patients receiving neoadjuvant or adjuvant treatments in fact.

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).