Pembrolizumab + Olaparib for Breast Cancer

This trial tests a combination of two drugs, pembrolizumab (an immunotherapy drug) and olaparib (a PARP inhibitor), to evaluate their effectiveness in treating advanced breast cancer. The focus is on patients whose cancer is linked to specific genetic issues, such as BRCA mutations or HDR defects, and who have not responded to previous treatments. It suits those who have progressed after standard therapies and have breast cancer associated with these genetic factors. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

The trial requires a washout period (time without taking certain medications) for specific drugs. If you are taking strong or moderate CYP3A inhibitors or inducers, you will need to stop them for 2 to 5 weeks before starting the trial. Additionally, if you are on systemic steroid therapy or certain antineoplastic therapies, you may need to discontinue them before participating.

Research has shown that the combination of pembrolizumab and olaparib has been tested in patients with certain advanced tumors. These studies found the combination to be generally safe, with no new safety issues reported. Patients tolerated the combination well, experiencing no unexpected side effects. Previous patients with similar gene mutations also demonstrated a tolerable safety profile. These findings suggest that the treatment could be a safe option for those considering joining the trial.¹²³⁴⁵

Researchers are excited about the combination of pembrolizumab and olaparib for advanced breast cancer because it offers a novel approach by targeting both the immune system and DNA repair mechanisms. Pembrolizumab works by unleashing the immune system to attack cancer cells, while olaparib is a PARP inhibitor that prevents cancer cells from repairing their DNA, leading to cell death. This dual mechanism is different from the standard treatments, which often rely on chemotherapy or hormone therapy alone, and it holds promise for more effective outcomes, especially in patients with BRCA mutations or HDR-defect associated breast cancer.

Research shows that combining pembrolizumab and olaparib may help treat advanced breast cancer in individuals with specific genetic traits, such as BRCA mutations or HDR defects. This trial will evaluate the combination in participants with these genetic features. Studies have found that this treatment can shrink tumors in some patients with these profiles. Pembrolizumab aids the immune system in fighting cancer cells, while olaparib inhibits a protein necessary for cancer cell repair. Early results suggest this combination is effective against tumors, with no new safety concerns identified, indicating potential effectiveness for those with the targeted genetic profiles.¹³⁴⁶⁷