Breast CancerNCT04510532
Early Detection of CMP in Patients With Breast Cancer Using Cardiac Magnetic Resonance
An observational study of Breast Cancer and Chemotherapy Induced Systolic Dysfunction, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Chemotherapy Induced Systolic Dysfunction
- What is being tested?
- CMR examination
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- Absence of known systemic diseases
- Normal examinations
- Age between 18-70 years old.
- Providing written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Yezi Chai, postgraduate, +8618221507985, cyz960707@126.com
Baohangxing Sun, postgraduate, +8615221478757, bowensun_0719@126.com
About this study
Official title: 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.
Read the 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.
- Being tested
- CMR examination
- Keywords
- Chemotherapy-induced Cardiomyopathy, pyrotinib/apatinib, Cardiac Magnetic Resonance, Echocardiography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR examinationDiagnostic test
Also called Echocardiography, EKG
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: CMR examination | |
| Control group | The controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings Receives: Diagnostic Test: CMR examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of cardiac condition
Compose of ejection fraction (%)
Measured: 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 (%).
Measured: change between 1 and 6 months after treatment
Exercise tolerance
6 minutes walking test
Measured: change between 1 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start30 Oct 2020
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Fudan University
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, MD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510532
- Sponsor's protocol ID
- 2020-08-06R
- Status last verified
- May 2023
- First submitted
- 7 Aug 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36844736
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Chemotherapy-related Cardiomyopathy in Patients With Breast Cancer Using Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT04510532
- Acronym / sponsor ID
- 2020-08-06R
- Keywords
- Chemotherapy-induced Cardiomyopathy, pyrotinib/apatinib, Cardiac Magnetic Resonance, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Fudan University
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Breast Cancer who use pyrotinib | – | Diagnostic Test: CMR examinationThe 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. |
| Patients with Breast Cancer who use apatinib | – | Diagnostic Test: CMR examinationThe 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. |
| Control group | – | Diagnostic Test: CMR examinationThe controls were healthy volunteers who have normal electrocardiographic and echocardiographic results and normal CMR findings |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMR examinationAlso: Echocardiography, EKGAfter 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 | Diagnostic test | Control group, Patients with Breast Cancer who use apatinib, Patients with Breast Cancer who use pyrotinib |
Primary outcome
Composite endpoint of cardiac condition
Time frame: change between 1 and 6 months after treatment
Compose of ejection fraction (%)
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 (%).
Exercise tolerance
Time frame: change between 1 and 6 months after treatment
6 minutes walking test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 36844736Chai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Jiang, MD study chair
RenJi Hospital, School of Medicine, Shanghai Jiantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chemotherapy Induced Systolic Dysfunction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Jiang, MD (+86 13788912766, jiangmeng0919@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of cardiac condition (time frame: change between 1 and 6 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.