Predicting heart problems in breast cancer patients receiving chemotherapy
Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy: a Prospective, Multicenter, Clinical Trial
This study is trying to see if a new way of monitoring heart function can help breast cancer patients receiving certain chemotherapy drugs catch heart problems early and improve their health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | First Hospital of China Medical University Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, radiation |
| Locations | 5 sites (Fuzhou, Fujian and 4 other locations) |
| Trial ID | NCT06282796 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to develop an intelligent model for the early prediction and warning of cardiotoxicity in patients undergoing anthracycline-based chemotherapy for breast cancer. By utilizing echocardiography to monitor changes in left ventricular ejection fraction and global longitudinal strain, the study seeks to identify asymptomatic cardiac dysfunction early, allowing for timely intervention. The goal is to improve patient outcomes by reducing the risk of chemotherapy-related cardiac issues, which can significantly impact survival rates. The findings could provide a theoretical basis for targeted myocardial protection strategies during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed stage I-III HER2+ breast cancer who are scheduled to receive anthracycline chemotherapy.
Not a fit: Patients with a life expectancy of 12 months or less, those participating in other oncology trials, or those with prior anthracycline treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and prevention of heart-related complications in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While the approach of using echocardiography for early detection of cardiotoxicity is established, the development of an intelligent predictive model in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Histologically or cytopathological confirmed stage I-III HER2+ breast cancer, scheduled to receive consecutive anthracycline chemotherapy or subsequent sequential trastuzumab targeted therapy * LVEF≥53% before chemotherapy Exclusion Criteria: * life expectancy ≤12 months * Participating in other ongoing oncology clinical trials * Prior treatment with anthracyclines or chest radiation therapy * Pregnant or lactating women * Ultrasound images of the heart are of very poor quality
Where this trial is running
Fuzhou, Fujian and 4 other locations
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- Dalian Friendship Hospital — Dalian, Liaoning, China (Recruiting)
- Dalian Municipal Central Hospital — Dalian, Liaoning, China (Recruiting)
- Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
- The Third People's Hospital Of Chengdu — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Yonghuai Wang, Ph.D — the First Hospital of China Medical Univeristy
- Study coordinator: Yonghuai Wang, Ph.D
- Email: wyh_wyh2012@163.com
- Phone: +86 15998323056
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.