Early Detection of CMP in Patients With Breast Cancer Using Cardiac Magnetic Resonance

May 30, 2023 updated by: RenJi Hospital

Early Detection of Chemotherapy-related Cardiomyopathy in Patients With Breast Cancer Using Cardiac Magnetic Resonance

Breast cancer is the most common cancers among women worldwide.Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. The investigators will focus on the cardiotoxicity of pyrotinib and apatinib which belong to the new tyrosine kinase inhibitors in respective chemotherapy among more subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer is the most common cancers among women worldwide. Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. We have focused on the field of chemotherapy-related cardiomyopathy. Using the unified magnetic resonance sequences and parameters, effect of chemotherapeutic drugs on the myocardium are studies. Our team's previous pilot study has found that chemotherapy-related cardiomyopathy (CMP) may be predicted within one week after chemotherapy initiation. The specific intervention timing, and the sensitivity and specificity of the early screening indicators are to be explored. At the same time, in patients with human epidermalgrowth factor receptor-2-positive breast cancer, our team observed the change of blood pressure, exercise tolerance and myocardial structure, function and tissue characteristics in patients who used tyrosine kinase inhibitors (pyrotinib and apatinib). This is a supplement to the existing drug knowledge. We are planning to further explore whether it is related to the patient's pre-existing cardiovascular diseases, drug type, dose or dosing. There are no published data addressing the above two research areas. The overall goal is to explore the commonness and specificity of myocardial changes after chemotherapy in breast cancer patients and to predict the development of CMP through multimodality imaging and clinical indices. We aim to propose the CMP time window in respective chemotherapy among more subjects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The subjects were prospectively enrolled into 3 cohorts between October 2019 and July 2020. The cohorts were divided as follows: the breast cancer patients with pyrotinib, the breast cancer patients with apatinib and the control group.

Description

Inclusion Criteria:

  • Age between 18-70 years old.
  • Invasive breast cancer confirmed by Pathology
  • Left ventricular ejection fraction ≥ 50%
  • Having not received any prior systemic anti-cancer therapy for advanced disease
  • an Eastern Cooperative Oncology Group（ECOG） performance status 0-1
  • Providing written informed consent

Inclusion Criteria for Control group:

  • Absence of known systemic diseases
  • Normal examinations
  • Age between 18-70 years old.
  • Providing written informed consent

Exclusion Criteria:

  • Age <18 years old or >70 years old
  • Documented coronary artery disease or prior angiography for coronary artery disease (>50% stenosis).
  • Patients with bilateral invasive breast cancers.
  • Patients with metastasis of breast cancer confirmed by imaging or pathology
  • Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate < 30 ml/min/1.73 m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings
Diagnostic test: CMR examination
After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on .And the follow-up is planned at 1,6 months after chemotherapy in order to detect the cardiac impairment
Other Names:
  • Echocardiography
  • EKG
Patients with Breast Cancer who use pyrotinib
The diagnosis of Breast Cancer was made based on the clinical classification criteria. The subjects were given pyrotinib as having HER2-positive breast cancer with no metastasis.
Diagnostic test: CMR examination
After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on .And the follow-up is planned at 1,6 months after chemotherapy in order to detect the cardiac impairment
Other Names:
  • Echocardiography
  • EKG
Patients with Breast Cancer who use apatinib
The diagnosis of Breast Cancer was made based on the clinical classification criteria. The subjects were given apatinib as having HER2-negative breast cancer with no metastasis.
Diagnostic test: CMR examination
After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on .And the follow-up is planned at 1,6 months after chemotherapy in order to detect the cardiac impairment
Other Names:
  • Echocardiography
  • EKG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite endpoint of cardiac condition
Time Frame: change between 1 and 6 months after treatment
Compose of ejection fraction (%)
change between 1 and 6 months after treatment
Composite endpoint of quantitative fibrosis assessment
Time Frame: change between 1 and 6 months after treatment
Compose of percentage of extracellular volume (%) and positive rate of late gadolinium enhancement (%).
change between 1 and 6 months after treatment
Exercise tolerance
Time Frame: change between 1 and 6 months after treatment
6 minutes walking test
change between 1 and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ruijin Hospital
Shanghai Fifth People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Meng Jiang, MD, RenJi Hospital, School of Medicine, Shanghai Jiantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-08-06R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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