Breast NeoplasmsNCT02942615
The Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
A study testing limit heart dose in people with Breast Neoplasms and Cardiotoxicity, run by Ruijin Hospital at 1 site in China.
Trial summary
This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Neoplasms, Cardiotoxicity
- What is being tested?
- limit heart dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2017to Oct 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing to participate the research and sign the informed consent file;
- Patients aged 18-80 years;
- KPS≥70;
- Pathological diagnosis for invasive breast cancer;
- Patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy;
- No functional heart disease;
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- LVEF≥50%;
- Patients received breast conserving surgery;
- Patients received modified radical mastectomy: T1-2 with N1-3 or T3-4 with any N;
- Tumor margin negative;
- No metastases;
- No other malignant tumor history.
Who cannot join
- Patients with metastases;
- Tumor margin positive;
- Patients received modified radical mastectomy with T1-2 and N0;
- Patients have other malignant tumor;
- Patients have a history of heart disease;
- Patients received chest radiotherapy previously;
Show all 11Show fewer
- Patients with severe organic and functional disease;
- Unqualified patients with sufficient reasons;
- Cannot or no willing to sign the informed consent file;
- Patients with autoimmune disease;
- Women with pregnancy, planned pregnancy or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Randomized Multi-center Phase III Study About the Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.
Read the detailed description
With the development of modern radiotherapy techniques, the dose-volume of heart irradiated could be kept in much low level. However, until now, the optimal dose-volume parameters for limiting heart irradiation, the optimal follow-up interval for cardiac safety after adjuvant radiotherapy, the optimal screening examinations and treatments for irradiation-induced cardiac toxicity are unclear. We designed this trial to find answer for above questions to establish rationalization proposal for prevention, treatment and follow-up for cardiac toxicity associated with adjuvant radiotherapy for breast cancer.
- Conditions
- Breast Neoplasms, Cardiotoxicity
- Being tested
- limit heart dose
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limit heart doseOther
Also called frequently follow of cardiac function, management of cardiotoxicity
limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%
| Study group | Role | What they receive |
|---|---|---|
| Heart safety management | Experimental | limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity Receives: Other: limit heart dose |
| Control group | No intervention | without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac toxicity event free survival
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
Measured: 1 year
Secondary outcomes (17)
cardiac toxicity event free survival
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
Measured: 5 years
cardiac toxicity event free survival
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
Measured: 10 years
overall survival
The time from the date of randomization to the date of death from any cause
Measured: 5 years
overall survival
The time from the date of randomization to the date of death from any cause
Measured: 10 years
relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 1 year
relative change of value of serum cardiac biomarkers of Cardiac troponin (cTn)-I
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 1 year
relative change of value of serum cardiac biomarkers of N-terminal pro brain natriuretic peptide (NT-proBNP)
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 1 year
relative change of value of serum cardiac biomarkers of CK-MB
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 5 years
relative change of value of serum cardiac biomarkers of cTn-I
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 5 years
relative change of value of serum cardiac biomarkers of NT-proBNP
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 5 years
relative change of left ventricular ejection fraction (LVEF)
The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 1 year
relative change of LVEF
The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapyThe change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 5 year
relative change of LVEF
The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Measured: 10 year
Quality of Life-EORTC QLQ-C30
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Measured: 1 year
Quality of Life-EORTC QLQ-BR23
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23
Measured: 1 year
Quality of Life-EORTC QLQ-C30
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Measured: 5 years
Quality of Life-EORTC QLQ-BR23
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start27 Jun 2017
- Primary completion8 Oct 2020
- Study completionOct 2025 (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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Shanghai 10th People's Hospital
- Responsible party
- Principal investigator, Jiayi Chen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942615
- Sponsor's protocol ID
- Cardio-RT
- Status last verified
- Dec 2022
- First submitted
- 19 Oct 2016
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cao L, Ou D, Qi WX, Xu C, Ye M, Fang YH, Shi M, Huang XB, Lin Q, Liu T, Cai G, Cai R, Chen M, Zhang YB, Su XX, Qian XF, Shen KW, Chen JY. A randomized trial of early cardiotoxicity in breast cancer patients receiving postoperative IMRT with or without serial cardiac dose constraints. Int J Cancer. 2025 Mar 15;156(6):1213-1224. doi: 10.1002/ijc.35245. Epub 2024 Nov 5.
PubMed 39499199
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multi-center Phase III Study About the Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
- ClinicalTrials.gov ID
- NCT02942615
- Acronym / sponsor ID
- Cardio-RT
- Conditions
- Breast Neoplasms, Cardiotoxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Shanghai 10th People's Hospital
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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.
This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.
Detailed description
With the development of modern radiotherapy techniques, the dose-volume of heart irradiated could be kept in much low level. However, until now, the optimal dose-volume parameters for limiting heart irradiation, the optimal follow-up interval for cardiac safety after adjuvant radiotherapy, the optimal screening examinations and treatments for irradiation-induced cardiac toxicity are unclear. We designed this trial to find answer for above questions to establish rationalization proposal for prevention, treatment and follow-up for cardiac toxicity associated with adjuvant radiotherapy for breast cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart safety management | Experimental | Other: limit heart doselimit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity |
| Control group | No intervention | –without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients willing to participate the research and sign the informed consent file;
- Patients aged 18-80 years;
- KPS≥70;
- Pathological diagnosis for invasive breast cancer;
- Patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy;
Key exclusion criteria (11 listed)
- Patients with metastases;
- Tumor margin positive;
- Patients received modified radical mastectomy with T1-2 and N0;
- Patients have other malignant tumor;
- Patients have a history of heart disease;
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 |
|---|---|---|
| limit heart doseAlso: frequently follow of cardiac function, management of cardiotoxicitylimit heart dose: Dmean≤6Gy,V30≤20%,V10≤50% | Other | Heart safety management |
Primary outcome
cardiac toxicity event free survival
Time frame: 1 year
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
17 secondary outcomes
cardiac toxicity event free survival
Time frame: 5 years
cardiac toxicity event free survival
Time frame: 10 years
overall survival
Time frame: 5 years
overall survival
Time frame: 10 years
relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB
Time frame: 1 year
relative change of value of serum cardiac biomarkers of Cardiac troponin (cTn)-I
Time frame: 1 year
relative change of value of serum cardiac biomarkers of N-terminal pro brain natriuretic peptide (NT-proBNP)
Time frame: 1 year
relative change of value of serum cardiac biomarkers of CK-MB
Time frame: 5 years
relative change of value of serum cardiac biomarkers of cTn-I
Time frame: 5 years
relative change of value of serum cardiac biomarkers of NT-proBNP
Time frame: 5 years
relative change of left ventricular ejection fraction (LVEF)
Time frame: 1 year
relative change of LVEF
Time frame: 5 year
relative change of LVEF
Time frame: 10 year
Quality of Life-EORTC QLQ-C30
Time frame: 1 year
Quality of Life-EORTC QLQ-BR23
Time frame: 1 year
Quality of Life-EORTC QLQ-C30
Time frame: 5 years
Quality of Life-EORTC QLQ-BR23
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 39499199Cao L, Ou D, Qi WX, Xu C, Ye M, Fang YH, Shi M, Huang XB, Lin Q, Liu T, Cai G, Cai R, Chen M, Zhang YB, Su XX, Qian XF, Shen KW, Chen JY. A randomized trial of early cardiotoxicity in breast cancer patients receiving postoperative IMRT with or without serial cardiac dose constraints. Int J Cancer. 2025 Mar 15;156(6):1213-1224. doi: 10.1002/ijc.35245. Epub 2024 Nov 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing limit heart dose in people with Breast Neoplasms and Cardiotoxicity, run by Ruijin 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 12 inclusion and 11 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 29 Dec 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac toxicity event free survival (time frame: 1 year). 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 NCT02942615, 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 29 Dec 2022.