A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
- All subjects must be female.
- Age ≥ 18 years old.
- Histologically proven carcinoma of the breast.
- Estrogen receptor and/or Progesterone positive disease.
- Metastatic or locally advanced disease.
- Patients on a preexisting endocrine agent for at least 3 months before enrollment.
- Have residual measurable disease after
1. maximal response to endocrine therapy or
2. no response to endocrine therapy or
3. progressive non-visceral disease on endocrine therapy.
- Must be able to provide a tumor block from either the primary or metastatic site, if
- ECOG Performance Status 0-2.
- Adequate organ function.
- 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
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's
- Known or suspected allergy to sorafenib or any agent given in the course of this
- 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 ≥ CTCAE Grade 2 within the 4 weeks prior to the
first dose of study drug.
- Any condition that impairs patient's ability to swallow whole pills.
- Documented malabsorption problem.