Clinical trial NCT00722072 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: fulvestrant, sorafenib tosylate
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H], CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    sponsor pulled funding and low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of incurable breast cancer

               -  Locally advanced or metastatic disease

          -  Measurable or evaluable disease

               -  Measurable disease is defined as ≥ 1 uni-dimensionally measurable lesion ≥ 20 mm
                  by conventional techniques or ≥ 10 mm by spiral computed tomography(CT) scan

                    -  Bone-only metastases that can be imaged with bone scan AND magnetic
                       resonance imaging (MRI) or bone scan AND plain x-ray is considered
                       measurable disease

                    -  Tumor lesions that are situated in a previously irradiated area are
                       considered measurable only if they are progressing at the time of study
                       entry

               -  Evaluable disease includes unresectable skin/chest wall metastases that can be
                  photographed and whose size can be measured with a ruler

                    -  Bone-only metastases that can only be imaged using bone scan or malignant
                       pleural effusion(s) only are not considered evaluable disease

          -  Previously treated with a third-generation aromatase inhibitor (e.g., letrozole,
             anastrazole, or exemestane) AND meets one of the following criteria:

               -  Progressed during palliative aromatase inhibitor therapy

               -  Recurred during adjuvant aromatase inhibitor therapy

               -  Recurred within 12 months of completing adjuvant aromatase inhibitor therapy

          -  Human Epidermal growth factor Receptor 2(HER2/neu)-negative tumor

               -  No Human Epidermal growth factor Receptor 2(HER2/neu) overexpression (i.e., tumor
                  staining 3+ by immunohistochemistry [IHC] or gene amplified by Fluorescence In
                  Situ Hybridization [FISH])

          -  Hormone receptor status:

               -  Estrogen receptor and/or progesterone receptor positive, defined as ≥ 10% of
                  malignant cells with positive nuclear staining

        PATIENT CHARACTERISTICS:

          -  Postmenopausal

          -  Eastern Cooperative Group(ECOG) performance status 0-1

          -  Life expectancy ≥ 16 weeks

          -  Neutrophil count ≥ 1,500/mm^³

          -  Platelet count ≥ 100,000/mm^³

          -  Hemoglobin ≥ 9.0 g/dL

          -  Creatinine < 2 mg/dL

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.5 times ULN (≤
             5 times ULN for patients with liver involvement)

          -  International Normalized Ratio(INR) < 1.5 OR Prothrombin time/ partial thromboplastin
             time (PT/PTT) normal

          -  Left ventricular ejection fraction(LVEF) normal by Multiple Gated Acquisition(MUGA) or
             ECHO

          -  No known allergy to sorafenib tosylate or fulvestrant

          -  No cardiac disease, including any of the following:

               -  New York Heart Association(NYHA) class III-IV congestive heart failure

               -  Unstable angina (anginal symptoms at rest) or new-onset angina (within the past 3
                  months)

               -  Myocardial infarction within the past 6 months

               -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

          -  No uncontrolled hypertension, defined as systolic blood pressure > 150 mm Hg or
             diastolic blood pressure > 90 mm Hg despite optimal medical management

          -  No thrombotic or embolic events, such as cerebrovascular accident (including transient
             ischemic attacks), within the past 6 months

          -  No known HIV infection or chronic hepatitis B or C infection

          -  No infection that requires IV antibiotics or produces a fever > 100°F within the past
             72 hours

          -  No pulmonary hemorrhage/bleeding event ≥ Common terminology criteria for adverse
             events(CTCAE) grade 2 within the past 4 weeks

          -  No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks

          -  No evidence or history of bleeding diathesis or coagulopathy

          -  No significant traumatic injury within the past 2 weeks

          -  No serious, nonhealing wound, ulcer, or bone fracture

          -  No condition that impairs the patient's ability to swallow whole pills

          -  No malabsorption problem

          -  No second malignancy within the past 5 years, except adequately treated and cured
             basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

          -  No underlying medical condition that, in the principal investigator's opinion, will
             make the administration of study drug hazardous or would obscure the interpretation of
             adverse events

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy for metastatic or unresectable locally advanced breast cancer

          -  No prior sorafenib tosylate or other Vascular endothelial growth
             factor(VEGF)-targeting therapies

          -  More than 2 weeks since prior major surgery or open biopsy

          -  No concurrent anticoagulation with warfarin or heparin

          -  No concurrent Hypericum perforatum (St. John wort) or rifampin

          -  No other concurrent anticancer agents, including chemotherapy or biological therapy

          -  No other concurrent investigational drugs

          -  Concurrent bisphosphonates allowed