Study of Oral Valganciclovir Treatment with Standard Care for Adults with Breast Cancer and Progressive Brain Metastases Infected with Cytomegalovirus

What this Trial Is About

Researchers are evaluating anti-cytomegalovirus CMV therapy combined with standard care in adults with metastatic breast cancer that has spread to the brain and shows active CMV infection. This phase II trial includes an initial safety lead-in to study the treatments effectiveness, safety, effects on brain function, and quality of life. Patients must have progressive brain metastases and evidence of CMV in the blood or antibodies to be eligible. Participants receive oral Valganciclovir at 900 mg twice daily for two weeks as induction therapy, followed by a maintenance dose of 450 mg twice daily for four weeks. Patients can undergo stereotactic radiosurgery SRS if at least one small lesion in a noncritical brain area remains untreated. The study includes a safety lead-in of at least 10 patients, followed by a phase II trial enrolling 18 patients to receive this combined treatment. During the study, participants undergo weekly blood tests during induction and biweekly during maintenance to monitor viral levels, blood counts, and electrolytes. Brain MRIs and neurocognitive tests are done regularly to assess tumor response and brain function. Quality-of-life questionnaires are also completed. Participants will be followed for 24 months, with adverse events recorded for two months after treatment. Correlative studies collect blood and tissue samples to better understand treatment effects.

Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection