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
To evaluate the preventive effects of EGCG on colonic tissue in patients with resected colorectal cancer when compared to patients on observation.
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.
1.1 To compare the event-free survival (EFS) of patients with IR RMS treated with surgery, radiotherapy, and VAC alternating with VI (VAC/VI) to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus (TORI).
1.2 To compare the overall survival (OS) of patients with IR RMS treated with surgery, radiotherapy, and VAC alternating with VI to that of patients treated with surgery, radiotherapy and VAC/VI plus TORI.
1.3.1 To compare the outcome of patients based on their FOXO1 fusion gene partner, by evaluation PAX3 vs. PAX7 in all patients found to be FOXO1 fusion positive.
1.3.2 To compare the outcome of patients based on their [F18]-fluorodeoxy-D-glucose-positron emission tomography (FDG-PET) response at Week 9 (positive or negative), as assessed by Deauville Criteria (5-point).
Non-inferiority of partial breast irradiation (PBI) and concurrent compared to sequential
chemotherapy with respect to acute grade 3-4 radiation toxicity.