Pembrolizumab + Cryoablation for Breast Cancer

This trial tests a new treatment for individuals with metastatic triple-negative breast cancer. It aims to determine whether combining pembrolizumab (an immunotherapy that helps the immune system fight cancer) with cryoablation (a procedure that freezes and destroys cancer cells) is more effective than pembrolizumab alone. Participants will be randomly assigned to receive either the drug alone or the drug with the freezing treatment. Those with breast cancer that has spread and can be treated with cryoablation might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new combination therapy.

The trial does not specify if you need to stop your current medications. However, it allows certain systemic therapies to be continued, so it's best to discuss your specific medications with your medical oncologist.

Research has shown that pembrolizumab is generally well-tolerated, even when combined with cryoablation. The FDA has approved pembrolizumab alone for other types of cancer, indicating its relative safety.

In studies where pembrolizumab was combined with cryoablation, results suggested this combination can be safe for treating breast cancer. Most side effects were mild to moderate, similar to those experienced with pembrolizumab alone, such as tiredness, fever, and mild pain at the cryoablation site.

Researchers are excited about the combination of pembrolizumab and cryoablation for treating metastatic triple negative breast cancer because it brings a novel approach to this challenging condition. Unlike traditional chemotherapy, which targets rapidly dividing cells broadly, pembrolizumab is an immunotherapy that specifically helps the immune system recognize and attack cancer cells. Cryoablation adds another layer of innovation by freezing and destroying tumor tissue directly, which can potentially enhance the immune response initiated by pembrolizumab. This dual approach not only targets the cancer more precisely but also aims to provoke a stronger and more sustained immune attack on the tumors.

In this trial, participants will receive either pembrolizumab alone or pembrolizumab combined with cryoablation. Research has shown that combining pembrolizumab with cryoablation might help the body's immune system fight triple-negative breast cancer more effectively. Studies have found that pembrolizumab alone can greatly improve survival rates for patients with this cancer type. When used with chemotherapy, pembrolizumab lowered the risk of the cancer worsening by 35% compared to a placebo. Cryoablation, which freezes cancer cells, may further enhance these effects by helping the immune system better target the cancer. Early research suggests that this combination could be more effective than using pembrolizumab alone.¹²⁶⁷⁸