Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: sorafenib
Intervention description: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; Sorafenib; Nexavar; Endocrine Therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             available.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

          -  Adequate organ function.

        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.