Palbociclib + Bicalutamide for Breast Cancer

This trial tests the safety and effectiveness of two drugs, palbociclib and bicalutamide (a type of hormone therapy), for treating a specific type of breast cancer called triple-negative, androgen receptor-positive breast cancer. The researchers will first determine the best dose and then evaluate the treatment's effectiveness. A suitable participant is a woman diagnosed with this type of breast cancer, with confirmed androgen receptors (proteins that bind to male hormones). As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking cancer treatment advancements.

The trial protocol does not specify if you must stop all current medications, but you should avoid medications that strongly affect CYP3A4, as they can interact with palbociclib. It's best to discuss your current medications with the trial team to see if any changes are needed.

Research is examining the safety of using palbociclib and bicalutamide together for certain types of breast cancer. Earlier studies show that bicalutamide is generally safe and may be effective for patients with specific breast cancer markers. The FDA has already approved palbociclib for other cancers, indicating it has passed safety tests for those uses.

Researchers are excited about the combination of Palbociclib and Bicalutamide for breast cancer because it targets the androgen receptor (AR) in a unique way. Unlike standard treatments for breast cancer that typically focus on hormone receptors like estrogen, this combination specifically addresses AR-positive, estrogen receptor-negative (ER-) breast cancer. Palbociclib is a CDK4/6 inhibitor that disrupts cancer cell division, while Bicalutamide blocks androgen activity. This dual approach could offer a new avenue for patients who do not benefit from traditional hormone therapies.

Research has shown that combining palbociclib with bicalutamide might help treat triple-negative, androgen receptor-positive breast cancer. In previous studies, palbociclib slowed the progression of other breast cancers. Bicalutamide blocks androgen receptors, which some breast cancers require for growth. Early results suggest that targeting these receptors could be a promising treatment approach for this cancer type. Although this trial is still evaluating the effectiveness of this combination for this specific cancer, its mechanism offers hope for potential benefits.¹²³⁴⁵