Elacestrant + Abemaciclib for Endometrial Cancer

This trial explores the effectiveness of two drugs, elacestrant and abemaciclib, in treating advanced or recurrent estrogen receptor-positive (ER+) endometrial cancer, which grows in response to estrogen. Researchers aim to determine whether using these drugs together or elacestrant alone is both safe and effective. Patients previously treated with chemotherapy and a PD-1 inhibitor, but not a CDK4/6 inhibitor, may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

The trial requires a 14-day period without chemotherapy or radiotherapy before starting. You should also avoid certain medications and herbal supplements that affect liver enzymes. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Research has shown that using elacestrant and abemaciclib together is generally safe. These drugs maintain similar safety levels when combined as when used separately, indicating no added risk of side effects. Common side effects of elacestrant alone include nausea, tiredness, and diarrhea, but these are usually mild.

Researchers are excited about these treatments for endometrial cancer because they target the cancer in new ways. Unlike current treatments like hormonal therapies and chemotherapy, Abemaciclib and Elacestrant work by uniquely targeting hormone receptors and the cell cycle. Abemaciclib is a CDK4/6 inhibitor that disrupts the cancer cell cycle, while Elacestrant is a selective estrogen receptor degrader (SERD) that reduces the influence of estrogen on cancer growth. This combination could potentially offer a more effective treatment option by attacking the cancer cells from different angles, possibly improving outcomes for patients who have limited options with traditional therapies.

This trial will compare the combination of elacestrant and abemaciclib with elacestrant alone for treating advanced or recurring ER+ endometrial cancer. Research has shown that using elacestrant and abemaciclib together yields promising results for advanced hormone receptor-positive cancers. In past studies with breast cancer patients, this combination prevented cancer progression for an average of 8.7 months. Specifically, patients' cancer did not progress for about 8.7 months on average. Elacestrant alone has also been effective, delaying cancer progression for about 5 to 7 months in similar cancer types. These findings suggest that these treatments might help manage advanced or recurring ER+ endometrial cancer by slowing its growth.¹⁵⁶⁷⁸