Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer

Inclusion Criteria:

Clear evidence of metastases to bone on isotope bone scan
Histologically or cytologically confirmed metastatic Estrogen-receptor-positive (ER+) and/or Progesterone-receptor-positive (PR+) and Human Epidermal Growth Factor Receptor (HER) 2 negative breast cancer
Received at least one prior line of hormonal or chemo-therapy for metastatic disease
must be post menopausal
Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, or other non-clinically significant Adverse Events (AEs)
Life expectancy > 3 months
Adequate organ and marrow function
Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
Able to lie flat for up to 45 minutes for imaging studies
Able to swallow capsules or tablets

Exclusion Criteria:

Pregnant or breast-feeding
Has experienced clinically-significant hematemesis or hemoptysis of > 0.5 teaspoons of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
Untreated, symptomatic or uncontrolled brain metastasis requiring current treatment including steroids and anti-convulsants
more than 1 prior line of chemotherapy for treatment of metastatic breast cancer
prior treatment with fulvestrant
Requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or Factor Xa inhibitors, and antiplatelet agents (eg, clopidogrel)
Uncontrolled or significant intercurrent illness
Gastrointestinal disorders, particularly those associated with a high risk of perforation or fistula formation
Active infection requiring systemic treatment
Serious non-healing wound/ulcer/bone fracture
History of organ transplant
Concurrent uncompensated hypothyroidism or thyroid dysfunction
Previously-identified allergy or hypersensitivity to components of the study treatment formulation
Diagnosis of another malignancy, requiring systemic treatment, within the last 2 years, unless non-melanoma skin cancer, in-situ carcinoma of the cervix, or superficial bladder cancer