NCT00638963

Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)

Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.

Detailed description

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).

Conditions

• Breast Neoplasm
• Brain Neoplasm
• Second Neoplasm

Interventions

Type	Name	Description
DRUG	temozolomide	Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles

Timeline

• Start date: 2008-10-02
• Primary completion: 2010-06-30
• Completion: 2010-06-30
• First posted: 2008-03-19
• Last updated: 2017-06-14
• Results posted: 2011-07-22