A radioactive drug as a new treatment option for advanced breast cancer?

Breast cancer (mammary carcinoma) is a malignant disease of the breast tissue characterized by the uncontrolled proliferation of breast cells. If the disease is already advanced (extensive spread within the breast and/or metastases), a cure may no longer be possible. It is precisely for this situation that new medications are constantly being researched to offer patients additional treatment options. One specific type of drug therapy involves the use of radioactive substances that can bind to cancer cells and then destroy them using radiation. Such therapies are already available for various other types of cancer; however, there are currently few such treatment approaches for breast cancer. [177Lu]Lu-NeoB is a new substance that recognizes a specific receptor on cells (known as GRPR). Breast cancer cells may also have this receptor on their surface, in which case this therapy can be used.

The goal of this study is to use [177Lu]Lu-NeoB for the first time in patients with breast cancer. It will be administered in combination with two established medications, ensuring that an effective treatment is available at all times. The goal is to investigate the appropriate dose, efficacy, and side effects. The study will last approximately 6 months, during which PET-CT imaging will be performed to evaluate the treatment’s effectiveness. Due to the radioactivity of [177Lu]Lu-NeoB, it will be necessary to avoid certain contacts (e.g., with pregnant women or children) and likely to spend some time in a special ward. The dose of [177Lu]Lu-NeoB will vary among patients and will also depend on the time of enrollment. Patients will be monitored regularly over a period of up to 5 years—initially every 8 weeks, later every 12 weeks, and eventually every 36 weeks.

Women and men aged 18 and older with hormone receptor-positive, HER2-negative, GRPR-positive advanced or metastatic breast cancer (stages 3–4) are eligible to participate in the study. Patients should have experienced an early recurrence of the disease following prior neoadjuvant therapy or early progression of the breast cancer following adjuvant therapy. The advanced or metastatic disease may have been treated only once previously.