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

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Cardiotoxicity; Breast Neoplasms

Treatments: Other: limit heart dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02942615

Cardio-RT

Details and patient eligibility

About

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 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Heart safety management

Experimental group

Description:

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

Treatment:

Other: limit heart dose

Control group

No Intervention group

Description:

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