Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)
Breast cancer is the second most common cause of brain metastases. Overall survival after
the development of brain metastases tends to be poor (6-8 months). Over-expression of Human
Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at
diagnosis seem to be indicators of high risk for brain metastases. Temozolomide may be a
good candidate for prophylactic chemotherapy because of its ability to cross the
blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Percent of Participants With Recurrence of Brain Metastases
The analysis could not be performed due to low enrollment.
1 Year
No
Italy: Ministry of Health
P05225
NCT00638963
October 2008
June 2010
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