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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04962425
Enrollment
240
Registered
2021-07-15
Start date
2021-01-08
Completion date
2021-12-30
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antitumor Drugs, Breast Cancer, Cardiac Toxicity

Keywords

Cardiac Toxicity, Antitumor drugs, Breast Cancer, Trastuzumab

Brief 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.

Interventions

DRUGTrastuzumab

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac toxicity12 monthsThe asymptomatic LVEF decreases ≥ 10% of the baseline value or to an absolute value \< 50%

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026