Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The case group | Trastuzumab for the treatment of breast cancer patients with cardiotoxicity. |
| |
| The control group | Trastuzumab is used to treat patients with breast cancer who do not present with cardiotoxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab [Herceptin] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac toxicity | The asymptomatic LVEF decreases ≥ 10% of the baseline value or to an absolute value < 50% | 12 months |
| Cardiac toxicity | acute or chronic heart failure | 12 months |
| Cardiac toxicity | New or aggravated arrhythmias or coronary heart disease | 12 months |
| Cardiac toxicity | Myocardial infarction or other cardiac death | 12 months |
Not provided
Not provided
Inclusion Criteria:
(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:
Not provided
Not provided
Not provided
All subjects were women aged >18 years, diagnosed with HER2-positive breast cancer and already receiving trastuzumab treatment.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |