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

NCT06161922 | Unknown

• 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 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 Outcomes (5)

• 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.

• TASQ-SC 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

RECRUITING

Study Officials

• Keda Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keda Yu, MD, PhD

CONTACT

+8618017317597; yukeda@fudan.edu.cn

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: October 26, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)