search
Back to results

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

Primary Purpose

Breast Neoplasms, Cardiotoxicity

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
limit heart dose
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Heart safety management

Control group

Arm Description

limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity

without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity

Outcomes

Primary Outcome Measures

cardiac toxicity event free survival
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity

Secondary Outcome Measures

cardiac toxicity event free survival
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
cardiac toxicity event free survival
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
overall survival
The time from the date of randomization to the date of death from any cause
overall survival
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
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
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)
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
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
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
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)
The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
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
relative change of LVEF
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
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Quality of Life-EORTC QLQ-BR23
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23
Quality of Life-EORTC QLQ-C30
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Quality of Life-EORTC QLQ-BR23
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23

Full Information

First Posted
October 19, 2016
Last Updated
December 27, 2022
Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Shanghai 10th People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02942615
Brief Title
The Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
Official Title
A Randomized Multi-center Phase III Study About the Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Cardiotoxicity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart safety management
Arm Type
Experimental
Arm Description
limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity
Arm Title
Control group
Arm Type
No Intervention
Arm Description
without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity
Intervention Type
Other
Intervention Name(s)
limit heart dose
Other Intervention Name(s)
frequently follow of cardiac function, management of cardiotoxicity
Intervention Description
limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%
Primary Outcome Measure Information:
Title
cardiac toxicity event free survival
Description
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
cardiac toxicity event free survival
Description
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
Time Frame
5 years
Title
cardiac toxicity event free survival
Description
The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
Time Frame
10 years
Title
overall survival
Description
The time from the date of randomization to the date of death from any cause
Time Frame
5 years
Title
overall survival
Description
The time from the date of randomization to the date of death from any cause
Time Frame
10 years
Title
relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB
Description
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
1 year
Title
relative change of value of serum cardiac biomarkers of Cardiac troponin (cTn)-I
Description
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
1 year
Title
relative change of value of serum cardiac biomarkers of N-terminal pro brain natriuretic peptide (NT-proBNP)
Description
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
1 year
Title
relative change of value of serum cardiac biomarkers of CK-MB
Description
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
5 years
Title
relative change of value of serum cardiac biomarkers of cTn-I
Description
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
5 years
Title
relative change of value of serum cardiac biomarkers of NT-proBNP
Description
The change of value of serum cardiac biomarkers during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
5 years
Title
relative change of left ventricular ejection fraction (LVEF)
Description
The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
1 year
Title
relative change of LVEF
Description
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
Time Frame
5 year
Title
relative change of LVEF
Description
The change of value of LVEF during and after adjuvant radiotherapy compared with baseline before initiation of adjuvant radiotherapy
Time Frame
10 year
Title
Quality of Life-EORTC QLQ-C30
Description
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Time Frame
1 year
Title
Quality of Life-EORTC QLQ-BR23
Description
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23
Time Frame
1 year
Title
Quality of Life-EORTC QLQ-C30
Description
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Time Frame
5 years
Title
Quality of Life-EORTC QLQ-BR23
Description
Quality of life will be assessed using self-administered questionnaire EORTC QLQ-BR23
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs