Phase IIa Study of Dendritic Cell Vaccines Against Her2Her3 and Pembrolizumab for Treating Brain Metastases from Triple Negative, HER2, or Hormone Receptor Positive Breast Cancer

What this Trial Is About

Researchers are evaluating the combination of dendritic cell vaccines targeting Her2Her3 and pembrolizumab for treating brain metastases in patients with triple negative breast cancer, HER2 breast cancer, or hormone receptor positive breast cancer. This phase IIa trial aims to assess how these treatments impact the central nervous system response, tumor size, progression-free survival, overall survival, and safety over time. The study explores immune system boosting and checkpoint inhibition to help the body recognize and attack cancer cells. During the treatment phase, participants receive intradermal injections of the anti-HER2HER3 dendritic cell vaccine on days 1, 22, and 43, alongside intravenous pembrolizumab infusions on the same days. In the maintenance phase, pembrolizumab is given intravenously every 21 days for up to two years, provided there is no disease progression or unacceptable toxicity. Participants may also receive booster doses of the dendritic cell vaccine every 3 to 6 months as deemed appropriate by the principal investigator. Participants will undergo various assessments, including brain imaging to measure tumor response, blood tests, and evaluations of disease progression in both the brain and systemic areas. Safety monitoring will continue for up to two years. Researchers will track outcomes such as brain response rate within six months, volumetric brain metastasis changes, systemic disease responses, progression-free survival, overall survival, and adverse events. The total study duration can extend up to two years, with ongoing evaluation of treatment effects and safety.

Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer