Could radiation therapy before surgery be better than the current standard of radiation therapy after breast surgery?

Breast cancer is one of the most common cancers among women, and the treatment method depends on many different factors. However, surgery is often necessary to remove the tumor. As a standard practice, chemotherapy (neoadjuvant) is administered beforehand to shrink the tumor and increase the chance of being able to remove it completely. To maximize the success of treatment, standard therapy in many cases includes treating the breast with radiation therapy (radiation) after surgery (postoperatively). Radiation therapy is also an established procedure in other cancer treatments and is often administered before surgery (preoperative). In the case of breast cancer, however, radiation therapy is typically administered only after surgery. Studies on preoperative radiation therapy in combination with neoadjuvant chemotherapy already exist, but the evidence to date is inconclusive. Early radiation therapy could potentially increase the rate of breast-conserving surgery (BCS) while simultaneously reducing the required radiation dose. This could not only improve the chances of disease-free survival but also reduce long-term side effects.

The goal of the NeoRad study is to investigate the effect of preoperative radiation therapy on disease-free survival.

To this end, patients will be randomly assigned to two groups. In the experimental arm, radiation therapy is administered before surgery and after neoadjuvant chemotherapy. In the control group, the current standard of care is followed: first, neoadjuvant chemotherapy, followed by surgery, and then postoperative radiation therapy. The study is open-label, meaning that both the medical staff and the patients know which group they have been assigned to. Patients will be followed for a minimum of six and a maximum of ten years.

Women aged 18 and older with early-stage breast cancer are eligible to participate in the study. In addition, radiation therapy must be indicated. The cancer must not have metastasized, but may have already spread to the lymph nodes. There must be no pre-existing conditions that would limit treatment, and patients with certain lung or heart diseases may be excluded from participation. Hormone receptor and HER2 status are neither inclusion nor exclusion criteria.