Palbociclib for Cancer

This trial tests a treatment called palbociclib (also known as Ibrance) to determine if it can shrink or stop the growth of certain cancers with specific genetic changes. Palbociclib blocks proteins that aid cancer cell growth. It targets individuals whose cancer exhibits genetic changes known as CCND1, 2, or 3 amplification. Ideal candidates for this trial have these genetic changes and have not previously received palbociclib or similar medications. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial does not specify if you need to stop all current medications, but you cannot use drugs or foods that strongly affect CYP3A4, an enzyme that processes many medications. It's best to discuss your current medications with the trial team.

Research has shown that palbociclib can be a safe treatment option, though it carries some risks. In a study with 444 patients, neutropenia, or a low level of white blood cells, was the most common side effect, increasing the likelihood of infections.

Long-term safety data on palbociclib indicates that its side effects usually remain consistent over time. However, other studies have found that palbociclib can also cause leukopenia (low white blood cells) and thrombocytopenia (low platelets, which help with blood clotting).

Researchers are excited about palbociclib because it offers a novel approach by targeting specific proteins involved in cell division, namely the cyclin-dependent kinases 4 and 6 (CDK4/6). Unlike traditional chemotherapy that attacks rapidly dividing cells indiscriminately, palbociclib selectively inhibits these kinases, potentially leading to fewer side effects and improved outcomes. This targeted action may provide a more tailored and effective treatment option for certain cancers, offering hope for patients whose disease has progressed despite standard therapies.

Research has shown that palbociclib can slow cancer cell growth by blocking proteins called CDK4 and CDK6. These proteins are often overly active in cancers with specific genetic changes known as CCND1, 2, or 3 amplifications. In studies with breast cancer patients, when combined with other treatments, palbociclib led to cancer shrinking or halting growth in over half of the patients (55.3%). Additionally, real-world data indicates that this combination can reduce the risk of disease progression by 30%. These findings suggest that palbociclib could be a promising treatment option for cancers with these genetic changes. Participants in this trial will receive palbociclib as the investigational treatment.⁶⁷⁸⁹¹⁰