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

NCT06161922 | Completed

• 1 other identifier: ML44677
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 1 year.

Secondary Outcomes (6)

• EORTC QLQ-C30

  Through study completion, an average of 1 year.

• PDQ-5 score

  Through study completion, an average of 1 year.

• PHQ-9 score

  Through study completion, an average of 1 year.

• GAD-7 score

  Through study completion, an average of 1 year.

• ISI score

  Through study completion, an average of 1 year.

Other Outcomes (5)

• Demographics characteristics

  Through study completion, an average of 1 year.

• Socio-economic status

  Through study completion, an average of 1 year.

• Clinical characteristics

  Through study completion, an average of 1 year.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Keda Yu

Shanghai, China

Location

Study Officials

• Keda Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 8, 2023
• Study Start: November 7, 2023
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)