Sapanisertib + Serabelisib for Breast Cancer

This trial tests two drugs, sapanisertib and serabelisib, to determine their effectiveness with fulvestrant in treating advanced breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-). The goal is to assess the safety and efficacy of these drugs for individuals whose cancer has spread or recurred after treatment. It targets those diagnosed with HR+/HER2- breast cancer that cannot be treated with surgery or radiation and have undergone at least one other therapy. As a Phase 1, Phase 2 trial, the research focuses on understanding the treatment's effects and measuring its efficacy in an initial, smaller group, offering participants a chance to contribute to early-stage cancer treatment advancements.

The trial requires that you stop taking strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or inducers, or clinically significant CYP3A4 inducers at least 7 days before starting the study. If you are on these medications, you will need to stop them before participating.

Earlier research tested the combination of sapanisertib and serabelisib with another drug, paclitaxel. These studies showed that the combination was safe and generally well-tolerated by patients. Participants did not report major safety issues, indicating that most people could handle the treatment. Overall, the combination demonstrated promising results in terms of safety and effectiveness. This suggests that sapanisertib and serabelisib are safe options for those considering joining the trial.¹²³⁴⁵

Researchers are excited about the combination of Sapanisertib and Serabelisib for breast cancer because it targets cancer cells in a unique way. Unlike traditional treatments like hormone therapies or chemotherapy, this combo specifically inhibits mTOR and PI3K pathways, which are key players in cancer cell growth and survival. This targeted approach could minimize damage to healthy cells, potentially leading to fewer side effects. Additionally, the combination is taken orally, offering a convenient alternative to some intravenous treatments. By combining these drugs with fulvestrant, which is a standard hormonal therapy, researchers hope to enhance treatment effectiveness against resistant types of breast cancer.

Research has shown that combining the drugs sapanisertib and serabelisib may help treat certain cancers. These drugs target key pathways in cancer cells, potentially stopping their growth. In this trial, participants will receive sapanisertib and serabelisib, along with fulvestrant, in varying dosages across two cohorts. Early results indicated that 73% of patients experienced some benefit, with their cancer not growing for about 11 months on average. Although more research is needed, these findings offer hope that these drugs could also be effective for advanced breast cancer.¹³⁶⁷⁸