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

NCT04962425 | Unknown DMC

• 1 other identifier: Cardiotoxicity study
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Toxicity; Antitumor Drugs; Breast Cancer

Keywords

Cardiac Toxicity; Antitumor drugs; Breast Cancer; Trastuzumab

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

The case group

Trastuzumab for the treatment of breast cancer patients with cardiotoxicity.

Drug: Trastuzumab

The control group

Trastuzumab is used to treat patients with breast cancer who do not present with cardiotoxicity

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

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

The case group; The control group

Eligibility Criteria

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

Study Population

All subjects were women aged \>18 years, diagnosed with HER2-positive breast cancer and already receiving trastuzumab treatment.

You may qualify if:

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

You may not qualify if:

• Patients who have not been properly treated with trastuzumab or have been treated for less than half a year;
• Patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment;
• Patients whose case data were missing or lost to follow-up.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

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; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 15, 2021
• Study Start: January 8, 2021
• Primary Completion: June 1, 2021
• Study Completion: December 30, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-01

Locations

CN (1)