Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek powyżej 18 lat
- •Rak piersi z przerzutami do mózgu, które się rozwijają
- •Co najmniej jeden przerzut do mózgu, który nie był wcześniej leczony
- •Obecność wirusa CMV we krwi (potwierdzenie badaniem lub przeciwciałami)
- •Zdolność do wyrażenia świadomej zgody na uczestnictwo w badaniu
- •Dobry ogólny stan zdrowia (skala ECOG 0-2)
- •Prawidłowe wyniki morfologii krwi (hemoglobina, neutrocyty, płytki)
- •Prawidłowa funkcja nerek i wątroby
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 8, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Houston Methodist Neal Cancer Center
Houston, United States
Trial contact
Milan Sheth
Titilayo Olubajo
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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