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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasms; Cardiotoxicity
• Intervention / Treatment: Other: limit heart dose

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 Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart safety management; limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity	Other: limit heart dose; limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%; Other Names: frequently follow of cardiac function; management of cardiotoxicity
No Intervention: Control group; without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	5 years
cardiac toxicity event free survival	The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity	10 years
overall survival	The time from the date of randomization to the date of death from any cause	5 years
overall survival	The time from the date of randomization to the date of death from any cause	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	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	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	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	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	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	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	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	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	10 year
Quality of Life-EORTC QLQ-C30	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30	1 year
Quality of Life-EORTC QLQ-BR23	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23	1 year
Quality of Life-EORTC QLQ-C30	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30	5 years
Quality of Life-EORTC QLQ-BR23	Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23	5 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital; Shanghai 10th People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): October 8, 2020
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Breast Neoplasms; Cardiotoxicity
• Other Study ID Numbers: Cardio-RT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No