Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metasta… (NCT07383649) | Clinical Trial Compass
RecruitingPhase 2
Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
United States28 participantsStarted 2026-05
Plain-language summary
This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female patients, aged ≥18 years, who have metastatic breast cancer with progressive brain metastases and CMV viremia (\> 250 copies/ml) or positive CMV IgG or IgM will be eligible to participate in the trial.
Patients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon/radiation oncologist. At least 10 patients will be enrolled in the initial safety lead-in followed by the Phase II trial which will include 18 patients.
Anti-HCMV therapy, oral Valganciclovir will be given to patients at 900 mg twice a day for 2 weeks. After the induction period, the maintenance will be continued with valganciclovir at 450 mg twice daily for 4 weeks (28 days).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female aged \>18 years at the time of consent
✓. Breast cancer with progressive brain metastases supra and/or infratentorial. Patients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon/radiation oncologist.
✓. At least one non irradiated, untreated progressive brain metastases site
✓. Serum HCMV DNA by real time PCR \> 250 copies/ml or positive CMV Ig G or Ig M.
✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. If the patient is unable to consent for any reason a legally authorized guardian may provide consent on their behalf. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) will be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
✓. Metastatic breast cancer who has systemically no evidence of disease, complete remission, partial remission, stable or progressive disease
✓. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
✓
What they're measuring
1
Objective Response Rate with anti-HMCV Therapy and SOC
. Adequate hematology without ongoing transfusion support (hemoglobin \> 9 g/dl, absolute neutrophil count (ANC) \> 1500 per mm3 , platelets \> 100,000 per mm3)
Exclusion criteria
✕. Single resectable intracranial lesion
✕. Last intracranial progression free survival \> 12 months
✕. All progressive brain metastases have been radiated
✕. Brain metastases needing immediate local intervention such as mass effect, herniation, active neurological symptoms, increased intracranial pressure, those near vital structures like the motor cortex, proximity to the optic nerve/chiasm or brain stem etc (can still be included if there are any other non-radiated progressive brain metastases) Multidisciplinary discussion with neurosurgery and radiation oncology will be needed to determine which patients may be safely enrolled on the trial.
✕. Active pregnancy or breast feeding
✕. Women of childbearing potential or fertile men unwilling to use effective contraception (Section 6.2, Table 6) during study and up to three months after treatment discontinuation.
✕. Known psychiatric disorder that causes poor cooperation with the trial requirements.
✕. Participants with previous other malignancies must have had at least a 3-year disease free interval, except those with non-melanoma skin cancer or carcinoma in situ of cervix