Trastuzumab Deruxtecan + Lovastatin for Breast Cancer

This trial explores whether adding lovastatin, a cholesterol-lowering drug, can enhance the effectiveness of trastuzumab deruxtecan for individuals with HER2-low or ultralow advanced metastatic breast cancer. The researchers aim to determine if lovastatin can increase HER2 expression and boost the treatment's impact. Individuals with HER2-low or ultralow breast cancer who have undergone no more than one previous chemotherapy treatment may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

The trial does not specify if you must stop all current medications, but you cannot have used statins within 7 days before starting the trial. Also, you should not be on any investigational agents or certain cancer therapies shortly before the trial begins.

Research has shown that trastuzumab deruxtecan (T-DXd) is generally safe for patients with HER2-low metastatic breast cancer. Some patients may experience side effects, but these are typically expected with this treatment.

Reports from patients and real-world data indicate that T-DXd is well-tolerated. Side effects can occur, but they are usually not severe enough to require stopping treatment. Lovastatin, the cholesterol-lowering drug tested with T-DXd, has FDA approval for other uses, supporting its general safety.

Researchers are excited about the combination of Trastuzumab Deruxtecan (T-DXd) and lovastatin for breast cancer because it introduces a novel approach to treatment. Unlike existing therapies that primarily focus on disrupting hormone signals or targeting HER2 proteins, T-DXd is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, potentially increasing effectiveness while minimizing damage to healthy cells. Additionally, the inclusion of lovastatin, typically a cholesterol-lowering drug, is believed to enhance the treatment's impact, possibly by affecting cancer cell metabolism or enhancing drug delivery. This innovative combination offers a fresh angle in tackling breast cancer, potentially leading to better outcomes for patients.

Studies have shown that trastuzumab deruxtecan (T-DXd) effectively treats HER2-low metastatic breast cancer. In real-world settings, more than half of the patients experienced tumor shrinkage, and about 62% survived after one year. On average, cancer progression took over seven months. In this trial, participants will receive a combination of T-DXd and Lovastatin. Researchers believe Lovastatin increases HER2 levels on cancer cells, potentially enhancing T-DXd's effectiveness. This combination aims to improve the treatment of advanced breast cancer.²⁵⁶⁷⁸