Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Exclusion Criteria

• •Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
• •Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
• •Prior use of anti-angiogenic agents.
• •As judged by the investigator, uncontrolled intercurrent illness.
• •Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• •Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• •Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
• •Known or suspected allergy to sorafenib or any agent given in the course of this trial.
• •A serious non-healing wound or ulcer.
• •Evidence or history of bleeding diathesis or coagulopathy.
• •Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
• •Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug.
• •Pregnancy
• •Any condition that impairs patient's ability to swallow whole pills.
• •Documented malabsorption problem.