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

Launched by PHYTOGEN MEDICAL FOODS S.L. · Mar 25, 2013

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• 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:
• • 1. Granulocytes ≥ 1,500/µL;
• • 2. Platelets ≥ 100,000/µL;
• • 3. Haemoglobin ≥ 12.0 g/dL;
• • 4. Total bilirubin equal to or below upper limit of normal (ULN);
• • 5. AST and ALT equal to or below ULN;
• • 6. Alkaline phosphatase equal to or below ULN;
• • 7. 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