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)
To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part.
To characterize the safety and tolerability of PCA062
To characterize the pharmacokinetic profile of PCA062
To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062
To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
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