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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962425
• Other study ID #: Cardiotoxicity study
• Status: Recruiting
• Start date: January 8, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 30, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female patients diagnosed with HER2-positive breast cancer treated in our hospital.

2. Surgical treatment combined with chemotherapy or radiotherapy was completed according to NCCN guidelines, and trastuzumab standard treatment was received for at least half a year.

(3) Cardiac function (including echocardiography or biomarkers) was assessed at least once within 3 months before trastuzumab treatment, and at least once during or after treatment was performed for heart-related tests.

(4) Complete case data.

Exclusion Criteria:

1. Patients who have not been properly treated with trastuzumab or have been treated for less than half a year;

2. Patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment;

3. Patients whose case data were missing or lost to follow-up.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiac Toxicity
• Cardiotoxicity

Intervention

Drug:
• Trastuzumab
Trastuzumab [Herceptin] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac toxicity	The asymptomatic LVEF decreases = 10% of the baseline value or to an absolute value < 50%	12 months
Primary	Cardiac toxicity	acute or chronic heart failure	12 months
Primary	Cardiac toxicity	New or aggravated arrhythmias or coronary heart disease	12 months
Primary	Cardiac toxicity	Myocardial infarction or other cardiac death	12 months