Clinical Trials

• # 1019524: Genomic Basis of Reproductive History on Breast Cancer. This study evaluates the biologic changes in a woman's breast related to pregnancy and nursing that lead to life-long protection (as compared with women who have never given birth) against breast cancer. Breast tissue from both normal women and women with breast cancer will be collected and analyzed for these studies.
  
  
• # 1021804: Association of Nipple Aspirates and Ductoscopy with Clinical Findings. This study is based on our belief that cytologic features and expression profiling of proteins and RNA will one day allow use of the noninvasive procedure of breast nipple aspiration to detect breast cancer. No needles are used for this diagnostic procedure and there is minimal or no discomfort.
  We also believe that ductoscopic samples collected nonsurgically with a fiberoptic scope that travels through the nipple ducts will also provide useful information to determine which women have breast cancer.
  We offer women who undergo diagnostic breast surgery (biopsy or mastectomy) the opportunity to undergo nipple aspiration and/or ductoscopy before or during their surgery. Biologic markers in the breast fluid and ductoscopic samples will be evaluated and compared to the breast tissue removed at the time of surgery.
  
  
• # 1022884: Celecoxib in Women at Increased Breast Cancer Risk. Celecoxib (celebrex) is a prostaglandin (PG) inhibitor that blocks PGE2 production. PGE2 is upregulated in breast cancer. Celebrex is FDA approved to prevent colon polyps, which can lead to colon cancer. We are studying whether celebrex may prevent breast cancer in women who are at increased risk of developing the disease. Women at greater risk are those who have a first degree relative with breast cancer, women who have atypical hyperplasia or in situ carcinoma, and women who have been treated for breast cancer in the past and are currently disease free. Women participating in the study will have breast fluid and blood collected three times: before celebrex, 2 weeks after starting and 2 weeks after stopping celebrex. We will evaluate breast cancer markers in the breast fluid and blood before and after treatment.
  
  
• # 1023047: Mitochondrial Mutations in Tumors and in Nipple Aspirate Fluid Collected from the Same Breast. Human cells have two types of DNA, nuclear and mitochondrial. The number of mitochondria are far greater in breast cancer than in normal cells, and the DNA in the mitochondria of breast cancer cells have mutations not seen in normal cells. We believe that breast fluid screening of mitochondrial mutations may aid in the early detection of breast cancer. In this study, we will collect breast fluid from women scheduled to undergo mastectomy and determine if the mitochondrial mutations present in the breast tumor tissue are also present in the breast fluid.
  
  
• # 1024525: Breast Cancer Biomarkers in Nipple Aspirates Treated with Estrogen Receptor Blockers. The Study of Tamoxifen and Raloxifene (STAR) is an international study enrolling 22,000 women to determine if raloxifene (Evista), a pill to fight osteoporosis, is as effective as or more effective than tamoxifen in preventing breast cancer. Many women not eligible for STAR are also taking tamoxifen or raloxifene to prevent breast cancer. For women scheduled to take either of these medications to prevent breast cancer, we believe that biologic markers in breast nipple aspiration can determine if a woman is responding (or not responding) to the medication that they are taking. This is important because women who are not responding may develop breast cancer. Women scheduled to start tamoxifen or raloxifene to prevent breast cancer who volunteer for this study will undergo breast nipple aspiration and blood draw at baseline and 6 months after taking the medication. Biologic markers of breast cancer are compared in the samples collected before and after starting the medication.
  
  
• # 1024344: Specimen Collection Study to Evaluate Biomarkers of Breast Cancer. This specimen collection study applies to the breast cancer studies above. Patients participating in these trials will sign two consents: the specific consent and the specimen collection consent.
  
  
• #1039927: The Effect of Black Cohosh Extract on the Human Breast. #1039927: The Effect of Black Cohosh Extract on the Human Breast. Women take black cohosh extract (BCE) to relieve menopausal symptoms. It may do this by affecting the estrogen receptor. There are estrogen receptors in many organs in the body, including the brain, the ovaries, the uterus, and the breast. This study will determine if ingestion of a standard preparation of BCE for 12 weeks by postmenopausal women experiencing menopausal symptoms 1) relieves their symptoms, 2) alters ovarian hormone levels, and 3) affects the breast. Breast fluid and one tube of blood will be collected at 4 visits: baseline, 4 weeks, 12 weeks and 24 weeks. We will assess the severity of hot flashes, markers of ovarian function and estrogen in the blood and breast fluid, and changes in shed breast cells after taking black cohosh. The woman will also complete paper and pencil questionnaires to evaluate food intake.
  
  
• #1042007: Phase IB Study of Biomarker Modulation by Celecoxib Versus Placebo in Newly Diagnosed Breast Cancer. This is a randomized, double-blind trial of celecoxib 400 mg BID vs placebo administered during the interval between biopsy and re-excision (duration of drug 10 days to 6 weeks) of women with newly diagnosed DCIS or small (T1 or T2) invasive breast cancer. Subjects will receive Celecoxib (400 mg BID) or Placebo for a planned treatment duration of at least 10 days (two weeks preferred), followed by re-excision. If scheduled re-excision is >2 weeks from study start, agent administration may be extended to 6 weeks to accommodate surgical schedules.
  Blood will be drawn for CBC, serum chemistries, as well as serum levels of estradiol, FSH, and SELDI protein pattern analysis, at baseline and at time of drug discontinuation prior to re-excision. Blood will also be drawn and stored for possible proteomics and plasma PGE2 analysis at a later date. Tissue will be collected from core biopsy and re-excision specimens to be processed into slides.

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