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

Ruijin Hospital220 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

220

Conditions

Breast Neoplasms Cardiotoxicity

Interventions

limit heart doseOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

cardiac toxicity event free survival

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

Time frame: 1 year

Secondary Outcomes

cardiac toxicity event free survival

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

Time frame: 5 years

cardiac toxicity event free survival

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

Time frame: 10 years

overall survival

The time from the date of randomization to the date of death from any cause

Time frame: 5 years

overall survival

The time from the date of randomization to the date of death from any cause

Time frame: 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

Time frame: 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

Time frame: 1 year

Data from ClinicalTrials.gov

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