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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Heart safety management
    • limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ruijin Hospital
  • Collaborator
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jiayi Chen, Chief of department of radiation oncology – Ruijin Hospital
  • Overall Contact(s)
    • Jia-Yi Chen, M.D., +86-021-64370045, chenjiayi0188@aliyun.com

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