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

NCT ID: NCT06161922

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2025-04-30

Brief 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.

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.

Conditions

HER2-positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Keda Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keda Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Keda Yu

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Keda Yu, MD, PhD

Role: CONTACT

Phone: +8618017317597

Email: yukeda@fudan.edu.cn

Facility Contacts

Keda Yu

Role: primary

Other Identifiers

ML44677

Identifier Type: -

Identifier Source: org_study_id