Conditions: Breast Cancer
Keywords: breast cancer Sorafenib Nexavar Endocrine Therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.

Detailed description:
A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.

Arms:
arm 1: Sorafenib \& Endocrine Therapy

Interventions: intervention 1: sorafenib
Intervention descriptions: intervention 1: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.

Protocol document: