Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy

NCT06282796 | Recruiting

• 1 other identifier: EPW-CABC-01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 5

Brief Summary

This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis.

Conditions

Breast Cancer

Keywords

Breast Cancer Chemotherapy; Anthracyclines; Cardiotoxicity; Early detection

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.

  To Evaluate the changes of cardiac systolic function in all breast cancer patients treated with anthracycline-based chemotherapy.

  1 day after admission

Secondary Outcomes (1)

• Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.

  1 day after admission

Study Arms (1)

Anthracycline-Based Breast Cancer Chemotherapy Group

Age ≥18 years, histologically or cytopathologically confirmed stage I-III HER2+ breast cancer, scheduled to receive consecutive anthracycline chemotherapy or subsequent sequential trastuzumab targeted therapy, with a prechemotherapy LVEF≥53%.

Device: Echocardiography

Interventions

Echocardiography DEVICE

Two-dimensional, color Doppler, spectral Doppler, tissue Doppler and three-dimensional echocardiographic image recordings will be taken using a Philips Epiq 7C echocardiography device and X5-1 probe. Conventional parameters, additional parameters, and strain analyzes will be performed by TomTec AutoStrain Suite Software

Anthracycline-Based Breast Cancer Chemotherapy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients with anthracycline-based breast cancer chemotherap

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (5)

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

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Yonghuai Wang, Ph.D

  the First Hospital of China Medical Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghuai Wang, Ph.D

CONTACT

+86 15998323056; wyh_wyh2012@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiovascular Ultrasound

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (5)