177Lu-DOTATATE for Advanced Breast Cancer

This trial tests the effectiveness of a new treatment called 177Lu-DOTATATE (Lutathera) for patients with advanced breast cancer that has either spread to other parts of the body (stage IV) or recurred after treatment. The treatment uses a radioactive agent to specifically target and kill cancer cells with a certain marker (SSTR2). This approach could help reduce tumor size and the number of cancer cells in the blood. Suitable candidates for this trial have experienced breast cancer spread or recurrence and have already tried at least two other treatments without success. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you stop taking short-acting somatostatin analogs 24 hours before and after the treatment, and long-acting somatostatin analogs at least 4 weeks before the treatment. Other chemotherapy or targeted therapy must be stopped 4 weeks prior to enrollment.

Research has shown that Lutetium Lu 177 Dotatate is generally safe for people. One study found that most patients tolerated the treatment well, and it worked as expected without causing serious problems. Another study found that 17% of patients with certain tumors showed improvement, indicating its effectiveness and safety.

Unlike the standard treatments for advanced breast cancer, which typically include chemotherapy, hormone therapy, and targeted therapies, Lutetium Lu 177 Dotatate offers a novel approach by utilizing targeted radiotherapy. This treatment is unique because it delivers radiation directly to cancer cells through a process called peptide receptor radionuclide therapy (PRRT), which binds to specific receptors on the tumor. Researchers are excited about this treatment because it has the potential to minimize damage to healthy cells while effectively targeting and destroying cancerous ones, offering a promising alternative for patients with advanced stages of the disease.

Research has shown that 177Lu-DOTATATE, which participants in this trial will receive, may help treat advanced cancers. In one study, patients who received this treatment had their cancer remain stable for an average of 17.43 months. This treatment targets cancer cells with a specific marker, SSTR2, and delivers radiation to destroy them. Another study found that 17% of patients experienced some tumor shrinkage. Overall, these findings suggest that 177Lu-DOTATATE could help reduce tumor size and slow the progression of advanced breast cancer.³⁴⁶⁷⁸