Evaluating patient-reported outcomes in Chinese women with HER2-positive early breast cancer receiving anti-HER2 therapy
Real World Patient-Reported Outcomes in Chinese Her2+ Early Breast Cancer Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Fudan University · NCT06161922
This study is trying to see how women in China with early HER2-positive breast cancer feel during and after their treatment with anti-HER2 therapy over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fudan University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06161922 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess patient-reported outcomes in Chinese women diagnosed with HER2-positive early breast cancer who are undergoing (neo) adjuvant anti-HER2 therapy. The study will collect primary data from approximately 10 sites across China, focusing on changes in patient-reported outcomes over a 12-month period. Participants will be evaluated at multiple time points, including baseline, during treatment, and at follow-up, using electronic devices for data collection. The study emphasizes the importance of patient perspectives in understanding treatment impact.
Who should consider this trial
Good fit: Ideal candidates for this study are Chinese women aged 18 and older, newly diagnosed with non-metastatic HER2-positive breast cancer who are eligible for anti-HER2 therapy.
Not a fit: Patients with metastatic breast cancer or those who have received prior systemic treatment for any malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the patient experience and improve treatment strategies for HER2-positive early breast cancer.
How similar studies have performed: While this approach is observational and focuses on patient-reported outcomes, similar studies have shown success in capturing valuable patient insights in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Keda Yu — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Keda Yu, MD, PhD — Fudan University
- Study coordinator: Keda Yu, MD, PhD
- Email: yukeda@fudan.edu.cn
- Phone: +8618017317597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HER2-positive Breast Cancer