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

Not Applicable

Active, not recruiting

• Conditions: Breast Neoplasms; Cardiotoxicity
• Interventions: Other: limit heart dose

• Registration Number: NCT02942615
• Lead Sponsor: Ruijin Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2017-06-27
• Primary Completion: 2020-10-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-29
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heart safety management	limit heart dose	limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity

Primary Outcome Measures

Name	Time	Method
cardiac toxicity event free survival	1 year	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity

Secondary Outcome Measures

Name	Time	Method
overall survival	10 years	The time from the date of randomization to the date of death from any cause
relative change of value of serum cardiac biomarkers of N-terminal pro brain natriuretic peptide (NT-proBNP)	1 year	The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
relative change of value of serum cardiac biomarkers of CK-MB	5 years	The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB	1 year	The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
relative change of value of serum cardiac biomarkers of Cardiac troponin (cTn)-I	1 year	The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Quality of Life-EORTC QLQ-C30	5 years	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
relative change of value of serum cardiac biomarkers of cTn-I	5 years	The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
relative change of left ventricular ejection fraction (LVEF)	1 year	The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Quality of Life-EORTC QLQ-BR23	5 years	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23
cardiac toxicity event free survival	10 years	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
relative change of value of serum cardiac biomarkers of NT-proBNP	5 years	The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
relative change of LVEF	10 year	The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China