Status:
UNKNOWN
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Lead Sponsor:
Fudan University
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
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 ther...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06161922
Start Date
October 26 2023
End Date
April 1 2025
Last Update
December 8 2023
Active Locations (1)
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1
Keda Yu
Shanghai, China