NCT04962425

Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

According to the existing clinical data in our hospital, retrospective study was conducted to screen the risk factors with predictive value for TRC(trastuzumab-related cardiotoxicity) risk, and to construct the risk prediction model for TRC.

Detailed description

The breast cancer patients with cardiotoxicity caused by trastuzumab were selected as the case group, and the breast cancer patients without cardiotoxicity were selected as the control group. The clinical baseline data, echocardiographic parameters and serum markers of the case group and the control group were compared to find out the risk factors that may have predictive value for the risk of TRC. The target factors were analyzed by univariate analysis and multivariate Logistic regression analysis, and the TRC risk prediction model was established.

Conditions

• Cardiac Toxicity
• Antitumor Drugs
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	Trastuzumab \[Herceptin\] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells.

Timeline

• Start date: 2021-01-08
• Primary completion: 2021-06-01
• Completion: 2021-12-30
• First posted: 2021-07-15
• Last updated: 2021-07-15

Locations

1 site across 1 country: China