Roberto Leon-Ferre, MD

Optimizing therapies for patients with early-stage triple-negative breast cancer.

Impact

Patients with triple-negative breast cancer (TNBC) face higher risks of early recurrence and death compared to other breast cancer subtypes. Chemotherapy, often combined with immunotherapy, is the standard treatment, even for early-stage TNBC. Most patients receive a combination of two to five drugs, increasing the risk of adverse side effects. Prior research has shown that artificial intelligence (AI) tools can measure how fast TNBC cells grow, and researchers can use that information to predict the chance of cancer coming back, especially in patients with low levels of immune cells in their tumors. In these patients, tumors shown to have slower growth had a low risk of recurrence while faster-growing tumors had a high risk. These tools may be able to help predict which patients require less aggressive therapies, avoiding exposure to severe side effects.

Progress Thus Far

For his Conquer Cancer Award supported by BCRF, Dr. Leon-Ferre and his team found that the level of immune cells within a tumor, known as tumor-infiltrating lymphocytes (TILs), is a strong, stable predictor of a patient’s risk of recurrence or death in early-stage TNBC, and may be sufficient on its own to guide treatment decisions. The team’s ongoing clinical trial (TIL-CHOICE), a prospective study is designed to use baseline TILs as a biomarker to tailor systemic therapy and safely de-escalate or omit chemotherapy in patients with early-stage TNBC.

What’s next

TIL-CHOICE will enroll approximately 1,200 patients believed to have stage I TNBC based on imaging and biopsy performed before surgery. Tumor samples will be evaluated for TIL levels to sort patients into two groups. Those with high TIL levels, expected to have a low risk of recurrence, will have surgery first and, if the surgical pathology confirms stage I disease, will be offered the choice to forgo chemotherapy altogether. Those with lower TIL levels will receive chemotherapy before surgery and be randomly assigned to either standard chemotherapy alone or chemotherapy combined with immunotherapy. The team is exploring whether tracking tumor DNA circulating in the blood can further refine risk of recurrence. The team also plans to evaluate a range of AI-based image analysis tools within the trial itself, using the large dataset to test whether these tools can reliably predict which patients might safely receive less aggressive treatment.