Clinical trial NCT02942615: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Cardiotoxicity
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai 6th People's Hospital
name: Shanghai 10th People's Hospital
First posted: 2016-10-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: cardiac toxicity event free survival
timeFrame: 1 year
Secondary outcomes:
measure: cardiac toxicity event free survival
timeFrame: 5 years
measure: cardiac toxicity event free survival
timeFrame: 10 years
measure: overall survival
timeFrame: 5 years
measure: overall survival
timeFrame: 10 years
measure: relative change of value of serum cardiac biomarkers of creatine kinase (CK)-MB
timeFrame: 1 year
measure: relative change of value of serum cardiac biomarkers of Cardiac troponin (cTn)-I
timeFrame: 1 year
measure: relative change of value of serum cardiac biomarkers of N-terminal pro brain natriuretic peptide (NT-proBNP)
timeFrame: 1 year
measure: relative change of value of serum cardiac biomarkers of CK-MB
timeFrame: 5 years
measure: relative change of value of serum cardiac biomarkers of cTn-I
timeFrame: 5 years
measure: relative change of value of serum cardiac biomarkers of NT-proBNP
timeFrame: 5 years
measure: relative change of left ventricular ejection fraction (LVEF)
timeFrame: 1 year
measure: relative change of LVEF
timeFrame: 5 year
measure: relative change of LVEF
timeFrame: 10 year
measure: Quality of Life-EORTC QLQ-C30
timeFrame: 1 year
measure: Quality of Life-EORTC QLQ-BR23
timeFrame: 1 year
measure: Quality of Life-EORTC QLQ-C30
timeFrame: 5 years
measure: Quality of Life-EORTC QLQ-BR23
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: