Cardiac ToxicityNCT04962425
Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients
An observational study of Cardiac Toxicity and Antitumor Drugs, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiac Toxicity, Antitumor Drugs, Breast Cancer
- What is being tested?
- Trastuzumab
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2021to 30 Dec 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All subjects were women aged >18 years, diagnosed with HER2-positive breast cancer and already receiving trastuzumab treatment.
Who may be able to join
- 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.
- 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.
- Complete case data.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Weixian Xu, 13810695447, xwxbird05@163.com
Xin Liu, 18801362704, liuxinlucile2019@163.com
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiac Toxicity, Antitumor Drugs, Breast Cancer
- Being tested
- Trastuzumab
- Keywords
- Cardiac Toxicity, Antitumor drugs, Breast Cancer, Trastuzumab
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Trastuzumab [Herceptin] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| The case group | Trastuzumab for the treatment of breast cancer patients with cardiotoxicity. Receives: Drug: Trastuzumab | |
| The control group | Trastuzumab is used to treat patients with breast cancer who do not present with cardiotoxicity Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac toxicity
The asymptomatic LVEF decreases ≥ 10% of the baseline value or to an absolute value < 50%
Measured: 12 months
Cardiac toxicity
acute or chronic heart failure
Measured: 12 months
Cardiac toxicity
New or aggravated arrhythmias or coronary heart disease
Measured: 12 months
Cardiac toxicity
Myocardial infarction or other cardiac death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start8 Jan 2021
- Primary completion1 Jun 2021
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ToxicityStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962425
- Sponsor's protocol ID
- Cardiotoxicity study
- Status last verified
- Jan 2021
- First submitted
- 27 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04962425
- Acronym / sponsor ID
- Cardiotoxicity study
- Conditions
- Cardiac Toxicity, Antitumor Drugs, Breast Cancer
- Keywords
- Cardiac Toxicity, Antitumor drugs, Breast Cancer, Trastuzumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Jul 2021 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The case group | – | Drug: TrastuzumabTrastuzumab for the treatment of breast cancer patients with cardiotoxicity. |
| The control group | – | Drug: TrastuzumabTrastuzumab is used to treat patients with breast cancer who do not present with cardiotoxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects were women aged >18 years, diagnosed with HER2-positive breast cancer and already receiving trastuzumab treatment.
Key inclusion criteria (4 listed)
- 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.
- 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.
- Complete case data.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| TrastuzumabTrastuzumab [Herceptin] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells. | Drug | The case group, The control group |
Primary outcome
Cardiac toxicity
Time frame: 12 months
The asymptomatic LVEF decreases ≥ 10% of the baseline value or to an absolute value < 50%
Cardiac toxicity
Time frame: 12 months
acute or chronic heart failure
Cardiac toxicity
Time frame: 12 months
New or aggravated arrhythmias or coronary heart disease
Cardiac toxicity
Time frame: 12 months
Myocardial infarction or other cardiac death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Cardiac Toxicity and Antitumor Drugs, run by Peking University Third 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 4 inclusion and 3 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 15 Jul 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac toxicity (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.