Capecitabine With Digoxin for Metastatic Breast Cancer

Inclusion Criteria

• •1. Patients ≥ 18 years of age with histologically confirmed, metastatic breast cancer resistant to anthracyclines and taxanes
• •2. Anthracycline resistance is defined as tumor progression during treatment or within 3 months of last dose in the metastatic setting, or recurrence within 6 months in the neoadjuvant or adjuvant setting. Alternatively, a minimum cumulative dose of anthracycline of 240 mg/m\^2 (doxorubicin) or 360 mg/m\^2 (epirubicin) has been reached, or there is contraindication to use anthracycline, the patient is also eligible
• •3. Taxane resistance is defined as recurrence within 4 months of the last dose in the metastatic setting or within 12 months in the adjuvant setting
• •4. Having progressed on anti-HER2 or hormonal therapy if they have HER2 positive or hormone-receptor positive breast cancer
• •5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy \>3 months.
• •6. Participants must have at least one target lesion as defined by RECIST 1.1 that allows for evaluation of tumor response
• •7. Absolute neutrophil count ≥ 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
• •8. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
• •9. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
• •10. At least three (3) weeks from prior chemotherapy
• •11. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.