Chemoimmunotherapy for Breast Cancer

(NeoTILs Trial)

This trial tests a new treatment for individuals with early-stage triple-negative breast cancer characterized by a high number of tumor-infiltrating lymphocytes (TILs). The study aims to determine if a combination of chemotherapy (carboplatin and paclitaxel) and immunotherapy (pembrolizumab) before surgery can effectively treat the cancer without using anthracyclines, which pose potential heart and bone marrow risks. After surgery, treatment continues based on the cancer's response, aiming to personalize care and avoid unnecessary strong treatments. Individuals with early-stage triple-negative breast cancer and high TILs might consider joining this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Previous studies have found the combination of carboplatin, paclitaxel, and pembrolizumab to be generally safe for patients with early-stage triple-negative breast cancer. Most patients can tolerate the treatment, though some side effects are expected. Research indicates that while this combination is effective, it can cause significant side effects that might necessitate dose adjustments or treatment pauses.

When used with chemotherapy, pembrolizumab has shown promising results in shrinking tumors before surgery. Earlier trials also found that combining pembrolizumab with chemotherapy is generally safe, but some patients may experience strong side effects.

Researchers are excited about this chemoimmunotherapy combination for breast cancer because it integrates immunotherapy with traditional chemotherapy. Pembrolizumab, an immunotherapy drug, helps the immune system recognize and attack cancer cells, unlike standard chemotherapy alone, which directly targets cell division. This combination aims to enhance the effectiveness of treatment, particularly for triple-negative breast cancer, which often lacks targeted therapy options. By using pembrolizumab alongside carboplatin and paclitaxel, the treatment could potentially improve outcomes by enabling a more robust immune response against cancer cells.

Research has shown that combining pembrolizumab with chemotherapy drugs like carboplatin and paclitaxel can help treat triple-negative breast cancer (TNBC). In this trial, participants will receive this combination as part of the neoadjuvant CPP regimen. Studies have found that this combination extends patient survival compared to chemotherapy alone. For example, one study found that 65% of patients were alive without cancer progression after 6 months when treated with pembrolizumab and chemotherapy, compared to 46.9% with chemotherapy alone. Another study showed that about 86.6% of patients with early-stage TNBC survived for a certain period when treated with this combination. These results suggest that this treatment approach may be particularly effective for patients with high levels of certain immune cells in their tumors.⁴⁶⁷⁸⁹