At a glance
ClinicalIndex Comparison Record- ✓Early breast cancer requiring radiation therapy
- ✓Mean heart dose 4 Gy or more and/or V20 lung 37% or more
- ✓Boost, breast reconstruction (any type except metal implants), connective tissue disease, post-operative complications, any breast size, and seromas allowed
- ✓Prior non-breast malignancy acceptable if disease-free ≥5 years with low recurrence risk
- ✕Prior breast cancer or ductal carcinoma in situ
- ✕Prior radiation therapy to chest region
- ✕Pregnant or lactating
- ✕Conditions preventing completion of radiation therapy or follow-up
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The DBCG Proton Trial. Adjuvant Breast Proton Radiation Therapy for Early Breast Cancer Patients: The Skagen Trial 2, a Clinically Controlled Randomised Phase III Trial
In Brief
A clinical study evaluating Proton versus photon radiation therapy for Early Breast Cancer and Radiation Associated Cardiac Failure. Currently recruiting, targeting 1,502 participants across 8 sites.
Signals
Detailed Summary
The majority of early breast cancer patients are treated with adjuvant radiation therapy (RT) as part of their multimodal therapy. The aim of the RT is to lower the risk of local, regional and distant failure and improve survival. Modern RT is been provided with photon therapy. Now, more proton therapy facilities are opened, including in Denmark. Proton RT may have the potential to cause lower dose to heart and lung during breast RT. This trial will randomise patients between standard photon RT versus experimental proton RT. The primary endpoint is 10 year risk of heart disease.
Study Details
Timeline
Interventions
The intervention is proton radiation therapy versus photon radiation therapy