Study Name:
Breast Cancer Prevention Using Synergistic Prostaglandin Inhibitors (SPI)

Sponsors:
Department of Defense Breast Cancer Research Program
The University of Texas Health Science Center at Tyler

Specific Aims:
This study is for women at an increased risk for breast cancer or those who had breast cancer and completed their treatment. The hypothesis is that vitamin D and celecoxib act synergistically to decrease breast cancer risk by decreasing cell proliferation in the mammary epithelium through their action on prostaglandin synthesis and metabolism. The focus is on the intraductal cell morphology, as well as systemic changes in blood samples due to intervention. The effects of vitamin D will be examined with and without added celecoxib.

Number of Visits:
2 Visits: Initial visit and at the end of the medication

Study Length:
30 days (or one complete menstrual cycle)

Eligibility:
High Risk Population: women with one or more first degree or two second degree relatives with breast cancer; personal history of breast cancer; a Gail risk > 1.66% in a 5 year period.

• Must be 18 years of age or older
• Eligibility based on laboratory evaluation of a CBC with PLT and Metabolic panel
• Negative urine pregnancy test
• Cannot have history of bilateral mastectomy or bilateral breast irradiation
• Not currently on Coumadin, Tamoxifen, Evista, Fermara, Arimidex, or Aromasin
• Has not undergone prior subareolar breast surgery
• Limitations of tanning booth use and previous intake of vitamin D in the past month
• Cannot have a history of asthma requiring medication for treatment or allergies to sulfonamides or NSAIDs
• No significant history of peptic ulcer disease, upper gastrointestinal bleeding, myocardial infarction or stroke

Study Name:
Prostaglandin Inhibition to Prevent Breast Cancer

Sponsors:
Susan G. Komen For the Cure
The University of Texas Health Science Center at Tyler

Specific Aims:
This study is for women at normal risk for breast cancer. The hypothesis is that vitamin D and celecoxib act synergistically to decrease breast cancer risk by decreasing cell proliferation in the mammary epithelium through their action on prostaglandin synthesis and metabolism. The focus is on breast specific changes. The effects of vitamin D will be examined with and without celecoxib.

Number of Visits:
2 Visits: Initial visit and at the end of the medications

Study Length:
30 days total (or one complete menstrual cycle)

• Must be 18 years of age or older
• Eligibility based on laboratory evaluation of a CBC with PLT and Metabolic panel
• Negative urine pregnancy test
• Cannot have history of bilateral mastectomy or bilateral breast irradiation
• Not currently on Coumadin, Tamoxifen, Evista, Fermara, Arimidex, or Aromasin
• Has not undergone prior subareolar breast surgery
• Limitations of tanning booth use and previous intake of vitamin D in the past month
• Cannot have a history of asthma requiring medication for treatment or allergies to sulfonamides or NSAIDs
• No significant history of peptic ulcer disease, upper gastrointestinal bleeding, myocardial infarction or stroke

Study Name:
Downregulation of Inflammatory Markers by Trans-Resveratrol: A Pilot Study

Sponsors:
The University of Texas Health Science Center at Tyler

Specific Aims:
The main purpose of this study is to determine if resveratrol, a natural compound found in red grape skin, red wine, peanuts, mulberries, and certain other plants such as Japanese knotweed can effect inflammatory biomarkers and acts, at least in part, by altering gene methylation.

Number of Visits:
2 visits: initial visit (baseline), and 4 week

Study Length:
4 weeks

• Women over the age of 18 and medically obese by BMI >30 kg/m2 definition. Both pre- and post-menopausal women are eligible.
• Participants must have one intact breast that has not received radiation therapy.
• They must not have taken non-steroidal anti-inflammatory drugs (NSAIDs) within the past 2 weeks, unless medically prescribed for regular dosing.
• They must not be planning any surgeries within the next month.
• They must not be pregnant, or have been pregnant or lactating in the past 24 months.
• If they are receiving chemotherapy or radiation therapy, or are currently taking Tamoxifen, aromatase inhibitors, exogenous estrogens and/or progestins they are not eligible.
• If the potential participant has a history of prior bilateral excisional breast biopsies in the past 3 months they will be excluded from the study.
• If they have taken Chinese, Ayurvedic, or Tibetian herbal medicines within the past 3 months they are not eligible.
• If they have taken any concentrated functional food supplements within the past month, they are not eligible.

Study Name:
Inflammation Changes Overtime in Obese, Overweight and Normal Weight Women

Sponsors:
The University of Texas Health Science Center at Tyler
Susan Love Foundation

Specific Aims:
Inflammation is present in both individuals with cancer and those who are obese. Inflammation is a process critical to the development and progression of breast cancer. Chronic inflammation is a hallmark sign of obesity. Ovarian hormones influence the expression of proteins involved in multiple pathways. We hypothesize that inflammation marker expression will be higher in breast fluid than in the circulating blood; that it will be higher in obese and overweight women compared with normal weight women; and will vary more through the menstrual cycle of premenopausal women compared to postmenopausal women over a 30 day period.

Number of Visits:
Every 3-4 day sample collection for 30 days>

Eligibility:
We plan to enroll 42 healthy women in this study at The University of Texas Health Science Center at Tyler half premenopausal and half postmenopausal. Each menopausal group will have 3 BMI categories (BMI > 30 kg/mg²; BMI <30 kg/mg² >25kg/mg²; BMI <25 kg/mg²).

• Women over 18 years old, half premenopausal and half postmenopausal. Each menopausal group will have 3 BMI categories (BMI > 30 kg/mg²; BMI <30 kg/mg² >25kg/mg²; BMI <25 kg/mg²)
• They must have one intact breast that has not received radiation therapy.
• They must not have taken non-steroidal anti-inflammatory drugs (NSAIDs) within the past 2 weeks.
• They must not be planning any surgeries within the next month. If they have a history of bilateral excisional breast biopsies in the past 3 months they are not eligible.
• If they are receiving chemotherapy or radiation therapy, or are currently taking Tamoxifen, aromatase inhibitors, exogenous estrogens and/or progestins.
• If they have presented to the doctor with SND (spontaneous nipple discharge) with or without palpable mass or radiological study will not be eligible.
• No significant medical or psychiatric problems making the participant a poor protocol candidate.
• Has not been pregnant or lactating in the last 2 years for breast participants

Study Name:
Biomarkers in Breast Milk

Sponsors:
Avon Foundation: Breast Cancer Prevention Research Initiative
The University of Texas Health Science Center at Tyler

Specific Aims:
The purpose of this study is to assess proteins secreted during the time of lactation which are up-regulated during breast involution (post lactation). YKL-40 is a protein that we think increases during post lactation (involution) and this protein is also present in nipple aspirate fluid (NAF) of women with precancerous activity of the breast.

Number of Visits:
  4 sample collections:
    Sample 1: colostrum and/or breast milk within 10 days of onset of lactation
    Sample 2: breast milk approximately 2 months after starting lactation
    Sample 3: breast milk at start of weaning (breast feeding a maximum of twice a day)
    Sample 4: approximately 1 year after weaning, this will be a NAF sample

• 18 years of age or older
• Participant has delivered after a full-term pregnancy
• Participant is postpartum and has or will begin breastfeeding
• No history of breast cancer and/or radiation to the breast
• No significant medical psychiatric problems making the subject a poor protocol candidate