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

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.

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Breast Cancer

Detailed Description

This is a non-interventional observational, multi-center cohort study with primary prospective data collection. This study will be conducted at approximately 10 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, before treatment), during chemotherapy (T1, after 2 cycles), 1-month after completion of 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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Keda Yu, MD, PhD; Phone Number: +8618017317597; Email: yukeda@fudan.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Keda Yu
    • Contact: Keda Yu; Phone Number: +8618017317597; Email: yukeda@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Patients aged ≥18 years;
2. Women;
3. Have signed the informed consent form as per local regulations;
4. Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy;
5. Be able to comply with the follow-up visits, assessments, answering questionnaires.

Exclusion Criteria:

1. Metastatic breast cancer;
2. Prior systemic treatment for any malignancy;
3. Active secondary cancer requiring anti-HER2 therapy;
4. 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;
5. Men.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC QLQ-C30 score	EORTC QLQ C30 /+ BR23(EORTC breast cancer-specific quality of life) questionnaire to evaluate quality of life. 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 1 score, "a little" for 2 score, "quit a bit" for 3 score and "very much" for 4 score. A higher score indicated a worse quality of life.	Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	Through study completion, an average of 1 year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics characteristics	Demographics characteristics: include age, height in meters, weight in kilograms, and WHO Performance Status score. The age of the patients will be measured in years, height will be documented by meters, weight by kilograms, and 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.	Through study completion, an average of 1 year.
Socio-economic status	Socio-economic status: include income, education, and marital status.	Through study completion, an average of 1 year.
Clinical characteristics	Clinical characteristics: include assessment of the primary site, histology, TNM stage, histological grade, ER/PR status, which will obtained from the pathology results. The primary site will be documented by surgeons and pathologists, histology will be decided by pathologists, 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.	Through study completion, an average of 1 year.
Treatment sequence (neoadjuvant vs adjuvant) checklist	Patients receiving neoadjuvant or adjuvant treatments in fact.	Through study completion, an average of 1 year.
Clinical treatment checklist	Clinical treatment: include breast surgery (Mastectomy vs Conservative surgery), axillary surgery (axillary dissection vs sentinel node biopsy), radiation therapy, anti-HER2 therapy (pertuzumab vs. pyrotinib), chemotherapy (yes vs. no)	Through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Keda Yu, MD, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ML44677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No