The Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.

Breast Neoplasms Clinical Trial

Official title:

A Randomized Multi-center Phase III Study About the Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02942615
• Other study ID #: Cardio-RT
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: October 2025

Study information

• Verified date: December 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: October 2025
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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;

• 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.

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cardiotoxicity

Intervention

Other:
• limit heart dose
limit heart dose: Dmean=6Gy,V30=20%,V10=50%

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Ruijin Hospital	RenJi Hospital, Shanghai 10th People's Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	1 year
Secondary	cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	5 years
Secondary	cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	10 years
Secondary	overall survival	The time from the date of randomization to the date of death from any cause	5 years
Secondary	overall survival	The time from the date of randomization to the date of death from any cause	10 years
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	5 years
Secondary	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	5 years
Secondary	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	5 years
Secondary	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	1 year
Secondary	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	5 year
Secondary	relative change of LVEF	The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy	10 year
Secondary	Quality of Life-EORTC QLQ-C30	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30	1 year
Secondary	Quality of Life-EORTC QLQ-BR23	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23	1 year
Secondary	Quality of Life-EORTC QLQ-C30	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30	5 years
Secondary	Quality of Life-EORTC QLQ-BR23	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23	5 years