This study is being conducted at medical centers around the country to compare two types of standard care radiation therapy: PHoton Therapy (pronounced “fo-tahn”) and PRoton Therapy (pronounced “pro-tahn”) — to find out which type of radiation is best for treating your type of breast cancer. Both treatments work and neither is experimental.

PHoton and PRoton therapy are both standard care radiation therapy treatments. Photon and Proton therapy deliver similar radiation doses to your chest wall, breast tissue, and immediate surrounding lymph node areas in front of the heart, above the collar bone, and/or below the armpit. The chart below compares each type of radiation. You may have side effects with either radiation treatment.

PHoton Therapy

Potential Benefits:

• Widely used to treat breast cancer for many years.
• Short- and long-term risks and benefits are well-documented.
• Doctors can aim and shape the radiation beams to treat your cancer. Potential Benefits:

Potential Risks:

• Passes through healthy tissues on its way to AND beyond the tumor target.
• Healthy tissue, like parts of the heart or lungs, can be damaged by the radiation, possibly causing side effects.
• Your skin may react to the radiation and the look and feel of your breast, breast implant or chest wall may change. Potential Risks:

PRoton Therapy

Potential Benefits:

• Passes through healthy tissues as it enters the body but stops after it has reached the target areas.
• This may cause less radiation damage to healthy tissue, like parts of the heart
• Doctors can aim and shape the radiation beams to treat your cancer.

Potential Risks:

• Short- and long-term risks and benefits are not as well-documented as photon therapy.
• Healthy tissue, like parts of the heart or lungs, can be damaged by the radiation, possibly causing side effects.
• Your skin may react to the radiation and the look and feel of your breast, breast implant or chest wall may change.

Doctors do not know if one type of radiation, PHoton or PRoton therapy, is better, about the same, or worse in terms of side effects, cure rates, length of life or quality of life after radiation.

We want to learn if one type of radiation (PHoton or PRoton Therapy) is better at helping you live longer or have a better quality of life.

Pragmatic clinical trials are designed to test treatment options in real-world settings to increase value to patients.

Taking part in this study may or may not make your health better. You are not promised to experience any direct benefit from participating in this study, but your participation may shape the future of breast cancer treatment by helping determine which radiation therapy is best for patients with your type of breast cancer.

If you have been diagnosed with non-metastatic breast cancer and will be having radiation therapy, you may be eligible for this study.

The RadComp study is being conducted at medical centers across the country. To find a participating site near you, visit our site page.

The total enrollment for this study is expected to take at least 5 years and then it will take approximately another 10 years to complete all analysis and reporting. If you decide to participate in this study you will be in the study until all the assessments are completed which will take about 10 years. Follow-up visits will be scheduled at 1 month, 6 months, and yearly from the end of radiation therapy. We will also call you every six months to check in about your health.

External beam radiation therapy is a cancer treatment that aims a beam (or many beams) of radiation through the skin to the breast or chest wall and the surrounding area to destroy cancer cells. When you receive radiation, a large machine aims the radiation and moves around you without touching you. Radiation therapy after surgery plays an important role in the treatment of breast cancer.

PHoton and PRoton therapy are both standard care radiation therapy treatments. Photon and Proton therapy deliver similar radiation doses to your chest wall, breast tissue, and immediate surrounding lymph node areas in front of the heart, above the collar bone, and/or below the armpit.

No, neither PHoton nor PRoton therapy are experimental. Both are FDA-approved radiation treatments and are on the cutting-edge of cancer therapy.

You should check to see if the radiation treatments in this study are covered by your health insurance. If they are covered, you may still be responsible for some costs, such as co-pays and deductibles. If your insurance will not cover a specific radiation treatment and you still want to participate, you will be responsible for paying for radiation treatment you receive.

Doctors do not know if one type of radiation is better, about the same, or worse in terms of side effects, cure rates, length of life or quality of life after radiation. By participating in the study, we will be monitoring your health long after radiation treatment. Your participation may also help decide which radiation therapy is best for future patients with your type of breast cancer.

This research study is funded by the Patient-Centered Outcomes Research Institute (PCORI) (Contract # PCS-1403- 12804). PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better- informed healthcare decisions.