Comparing Proton and Photon Radiation Therapy for Early Breast Cancer
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
This study is testing whether proton radiation therapy is better than standard photon radiation therapy for early breast cancer patients by looking at its effects on heart health over 10 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1502 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danish Breast Cancer Cooperative Group Academic / other |
| Drugs / interventions | radiation |
| Locations | 8 sites (Aalborg and 7 other locations) |
| Trial ID | NCT04291378 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness of proton radiation therapy versus standard photon radiation therapy in patients with early breast cancer who require adjuvant radiation. The study will randomize participants to receive either treatment, focusing on the potential benefits of proton therapy in reducing radiation exposure to the heart and lungs. The primary endpoint is the 10-year risk of heart disease, which is a significant concern for patients undergoing radiation therapy. By investigating this approach, the trial seeks to improve treatment outcomes and minimize long-term side effects associated with radiation.
Who should consider this trial
Good fit: Ideal candidates are patients with early breast cancer who are scheduled for radiation therapy and have a mean heart dose of 4 Gy or more.
Not a fit: Patients with previous breast cancer, those who have undergone radiation therapy to the chest, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer radiation therapy options that reduce the risk of heart disease for breast cancer patients.
How similar studies have performed: While proton therapy has been explored in other contexts, this specific comparison in early breast cancer treatment is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient operated for early breast cancer with indication for radiation therapy, where standard planning shows a mean heart dose 4 Gy or more and/or a V20 lung of 37% or more. * Boost (breast, chest wall and nodal), breast reconstruction (any type, except implants with metal), connective tissue disease, post-operative surgical complications, any breast size and seromas are allowed * Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist estimates a low risk of recurrence. * Life expectancy minimum 10 years Exclusion Criteria: * previous breast cancer/ductal carcinoma in situ, * Previous RT to the chest region * Pregnant or lactating * Conditions indicating that the patient cannot go through the RT or follow up * Patients with Pacemaker or defibrillator are excluded until a guideline for handling them has been developed at the DCPT * Unknown non-tissue implants upstream of the target volume. NB. all such non-tissue, non-metal objects must be delivered to the DCPT for stopping power determination and evaluation at least a week prior to radiation start. * Metal implants in the radiation area, including metal in implants.
Where this trial is running
Aalborg and 7 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- The Danish Breast Cancer Cooperative Group — Copenhagen, Denmark (Not_yet_recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Herlev Hospital — Herlev, Denmark (Recruiting)
- Naestved Hospital — Næstved, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Vejle Hospital — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Birgitte V Offersen, phd — Danish Breast cancer Cooperation Group (DBCG)
- Study coordinator: Birgitte V Offersen, phd
- Email: birgoffe@rm.dk
- Phone: +45 28838012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.