Assess the impact of dietary omega 3 FFA:
Serum CSF-1 levels
patient serum-induced expression of PGE2 by neoplastic mammary epithelial cells, OM3/OM6
circulating levels of pro-inflammatory cytokines (i.e. IL-6, TNF- , IGF-1), steroids (i.e. estrogen and testosterone) and lipids (omega-6 and omega-3 PUFAs)
Tissue expression of aromatase, CSF1/CSF1R and infiltrating macrophage number and polarity.
To evaluate the Objective Response Rate (ORR) of poziotinib in patients with HER2-positive metastatic breast cancer (MBC)
To assess the safety and tolerability of poziotinib in patients with HER2-positive MBC
To evaluate other efficacy variables of poziotinib in patients with HER2-positive MBC,
including the following:
Progression-Free Survival (PFS)
Disease Control Rate (DCR)
Overall Survival (OS)
Time to Progression (TTP)
Primary Outcome Measures:
The percentage of patients who are alive without disease progression
Assess the percentage of patients without disease progression based on local investigator assessment per RECIST in cohort A and cohort B
To conduct a pilot breast cancer prevention study of hydroxytyrosol in women at increased risk of breast cancer.
To assess whether mammographic density is reduced in pre or post menopausal women at high risk of breast cancer taking hydroxytyrosol for 1 year compared with baseline.
To assess the toxicity of hydroxytyrosol
After a baseline breast tumor core biopsy, eligible women with triple negative breast cancer (ER- alpha, PR and HER-2 receptor negative) will be treated with S-equol at a dose of 50 mg twice daily for a period of about 14 days (10-21 day range). After completion of treatment, a second breast tumor sample will be obtained to compare molecular changes between the two specimens. The second pathology specimen may be from the surgical resection of the breast tumor, or a repeat core needle biopsy, if no further surgery is planned. The primary endpoint will be the absolute change in the Ki67, which is a validated marker of tumor proliferation in breast cancer. Secondary endpoints will include assessment of total ER-beta and pY36 levels as measured by immunohistochemical staining and their correlation with S-equol effects. Further treatment after surgical resection or second core needle biopsy of the tumor will be guided by tumor size, nodal status and other standard parameters, and is at the discretion of the treating physician. The Investigator hypothesizes that S-equol will cause a measurable decrease in Ki-67 in estrogen receptor beta expressing triple negative breast cancers, indicating its potential efficacy in this tumor type.