Comparing Proton and Photon Radiation Therapy for Early Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Naestved Hospital
  Næstved, Denmark Recruiting
• Odense University Hospital
  Odense, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.