Defining the Molecular Profile of Breast Cancer in Uganda and its Clinical Implications
Women = 18 years of age, with any menopausal status, with newly diagnosed, locally advanced and histologically confirmed invasive breast cancer (Patients with stage 2B (i.e. T3N0), 3A, 3B, and 3C disease)
Adequate bone marrow function: ANC > 1500/mm, hemoglobin > 9 g/dL, and platelets = 100,000 cells/mm3
Adequate hepatic function: Total bilirubin =1.2 mg/dL, INR =1.5x ULN, AST and ALT=1.5x ULN. Serum alkaline phosphatase should be = 1.5x ULN. Patients with positive Hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, INR, aPTT, and alkaline phosphatase on at least two consecutive occasions, separated by at least 1 week.
Adequate renal function with serum creatinine
Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.
Women of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment.
Left ventricular ejection fraction > 50%
ECOG performance status
Signed written informed consent
Other eligibility criteria may apply.
A treatment-free interval of
Active, unresolved infection or systemic disease (e.g. pulmonary or metabolic disease)
Patients with active liver disease
Patients with active cardiac disease, including congestive heart failure (or therapy specifically for CHF)
Patients with uncontrolled hypertension (diastolic >100 mmHg or systolic > 160 mmHg)
Known hypersensitivity to any of the drugs
Significant current illness (including psychiatric illness)
Any social situations or other conditions that in the opinion of the investigator limit compliance with study requirements.
Patients that have received treatment with Sorividine or Brividine (herpex) or any related analogue within 4 weeks prior to starting the IP
Patients on any of the following medications: Acitretin, Azathioprine, BCG (intravesicular), Belimumab, Deferiprone, Diphyrone, Etanercept, Foscarnet, Gimeracil, Levetriracetam, Natalizumab, Pimercrolimus, Retinoids, Sulfazalazine, Tacrolimus Tofacitininb
Patients receiving any anticoagulation (including warfarin)
Other exclusion criteria may apply.