68Ga-R11228 + 177Lu-R11228 for Breast Cancer

This trial explores two new treatments, 68Ga-R11228 and 177Lu-R11228, for breast cancer that has returned or spread. Researchers aim to determine if these treatments can manage the cancer more effectively. The trial is divided into two parts: one seeks the optimal dose of 68Ga-R11228, a diagnostic imaging agent, while the other combines imaging with 68Ga-R11228 and varying doses of 177Lu-R11228, a therapeutic agent. Individuals with estrogen or progesterone receptor-positive, HER2-negative breast cancer that has not responded to previous treatments might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had anticancer therapy or an investigational drug within 21 days or 5 half-lives of the agent before joining Part B of the trial.

Research has shown that both 68Ga-R11228 and 177Lu-R11228 are being tested for safety in treating breast cancer. The current phase 1 trials primarily aim to determine if these treatments have manageable side effects. As this is an early stage of testing, detailed safety results are not yet widely available.

Phase 1 trials are the initial step in testing new treatments in people, with a strong focus on safety. Doctors closely monitor for any side effects. Although specific data from these trials is limited, the progression to human studies suggests that earlier lab and animal tests deemed the treatments safe enough.

Unlike the standard treatments for breast cancer, which typically involve chemotherapy, hormone therapy, or targeted therapy, the combination of 68Ga-R11228 and 177Lu-R11228 represents a novel approach using radiopharmaceuticals. Researchers are excited about these treatments because they use radioactive isotopes to target and destroy cancer cells directly. 68Ga-R11228 is used for imaging, helping to visualize the cancer, while 177Lu-R11228 delivers targeted radiation therapy to the tumor. This dual-action strategy of precise imaging followed by targeted treatment has the potential to improve accuracy and effectiveness, minimizing damage to healthy tissues.

This trial will evaluate two separate treatments for breast cancer. Part A involves 68Ga-R11228, designed to locate cancer spots in the body and potentially improve breast cancer detection. This substance highlights cancerous areas in scans, making them easier for doctors to see. Part B involves both 68Ga-R11228 for imaging and 177Lu-R11228, intended to treat cancer spots with specific positive markers. This method targets cancer cells specifically, potentially enhancing treatment effectiveness. Early findings suggest these experimental treatments might help manage breast cancer by improving detection and directly targeting cancer cells.²³⁴⁶⁷