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

NCT04510532 | Unknown DMC

• 1 other identifier: 2020-08-06R
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Chemotherapy Induced Systolic Dysfunction

Keywords

Chemotherapy-induced Cardiomyopathy; pyrotinib/apatinib; Cardiac Magnetic Resonance; Echocardiography

Outcome Measures

Primary Outcomes (3)

• Composite endpoint of cardiac condition

  Compose of ejection fraction (%)

  change between 1 and 6 months after treatment

• Composite endpoint of quantitative fibrosis assessment

  Compose of percentage of extracellular volume (%) and positive rate of late gadolinium enhancement (%).

  change between 1 and 6 months after treatment

• Exercise tolerance

  6 minutes walking test

  change between 1 and 6 months after treatment

Study Arms (3)

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

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

Control group

The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings

Diagnostic Test: CMR examination

Interventions

CMR examination DIAGNOSTIC_TEST

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

Also known as: Echocardiography, EKG

Control group; Patients with Breast Cancer who use apatinib; Patients with Breast Cancer who use pyrotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Fifth People's Hospital: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• Chai Y, Jiang M, Wang Y, Liu Q, Lu Q, Tao Z, Wu Q, Yin W, Lu J, Pu J. Protocol for pyrotinib cardiac safety in patients with HER2-positive early or locally advanced breast cancer-The EARLY-MYO-BC study. Front Cardiovasc Med. 2023 Feb 10;10:1021937. doi: 10.3389/fcvm.2023.1021937. eCollection 2023.

  PMID: 36844736 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Echocardiography; Electrocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Officials

• Meng Jiang, MD

  RenJi Hospital, School of Medicine, Shanghai Jiantong University

  STUDY CHAIR

Central Study Contacts

Meng Jiang, MD

CONTACT

+86 13788912766; jiangmeng0919@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 12, 2020
• Study Start: October 30, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)