Changes in Biomarkers of Cancer in Women With Breast Cancer and Without Evidence of Disease Who Were Given PhytoMed™

Inclusion criteria

• Women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected.
• No evidence of disease as determined by their physician.
• ER+ and/or PR+ tumour.
• Receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable dose for at least 3 months at trial entry.
• Post-menopausal women, defined as: (1) above 50 years of age who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone levels (FSH) > 40 IU/L, (2) those under 50 years of age who have FSH hormone levels >40 IU/L, or (3) those who have undergone a bilateral oophorectomy.
• CRP ≥3.9 mg/L measured as the mean of two consecutive weekly tests.
• Aged 18 years or older
• ECOG performance status 0-1
• Between 2 and 5 years from their initial surgery for breast cancer.
• Life expectancy of at least 6 months
• At least 6 months since last chemotherapy
• Laboratory tests performed within 14 days of trial starting:

• Granulocytes ≥ 1,500/µL;
• Platelets ≥ 100,000/µL;
• Haemoglobin ≥ 12.0 g/dL;
• Total bilirubin equal to or below upper limit of normal (ULN);
• AST and ALT equal to or below ULN;
• Alkaline phosphatase equal to or below ULN;
• Serum creatinine equal to or below ULN;
• Able to provide informed consent to receive the trial treatment, to provide biological specimens, self-administer oral medica-tion unsupervised for a prolonged period of time, and to complete a medication diary.

Exclusion criteria

• Pregnancy or breastfeeding
• Who have had a malignancy (other than breast cancer) which required radiotherapy or systemic treatment within the past 5 years.
• Known cardiac disease (arrhythmias, myocardial infarction, bundle branch block, ischemic heart disease, uncontrolled hypertension)
• Known autoimmune disease or inflammatory disorder
• Any condition requiring the use of systemic corticosteroids or any other immunosuppressive agents (e.g. cyclosporin, tacrolimus, azathioprine).
• Women with known immunodeficiency (such as HIV).
• Patients with infection by septicaemia, infection, acute hepatitis, or other uncontrolled severe medical condition
• Routine use of aspirin >81 mg/d or NSAIDs (> 400 mg po 4 times/day of ibuprofen or naproxen > 500 mg/d) or any use of celecoxib or similar COX-2 inhibitors;
• Subjects are asked not to take dietary supplements, olives or olive oil for 1 month prior to trial enrolment and during the trial.
• Who are taking bisphosphonates