NCT02942615

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms
• Cardiotoxicity

Interventions

Type	Name	Description
OTHER	limit heart dose	limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%

Timeline

• Start date: 2017-06-27
• Primary completion: 2020-10-08
• Completion: 2025-10-01
• First posted: 2016-10-24
• Last updated: 2022-12-29

Locations

1 site across 1 country: China