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Clinical Cancer Prevention Research Programs

Patient and Survivor Prevention Studies

Lapatinib for the Treatment of DCIS Breast Cancer

Contact Number: 713-563-5424
Principal Investigator:  Powel H. Brown, M.D., Ph.D.
Status: Open to new patient accrual
Population: Patients with newly diagnosed stage 0 DCIS breast cancer Brief criteria for accrual (screening available for participants)

Eligible:

  • Patients who have newly diagnosed ductal carcinoma in situ breast cancer by core biopsy.
  • Patients who are pre- or post-menopausal, 21 or older females.
  • Patients who have positive markers for EGFR or Her2 Neu.
  • Patients who have adequate heart, kidney, and liver function.

Ineligible:

  • Patients who have received Active Cancer treatment in the last 12 months will be ineligible.
  • Patients with severe underlying chronic illness will be ineligible.

Brief Description: 2008-0086 Neoadjuvant Trial of Lapatinib for the Treatment of Women with DCIS Breast Cancer. This is a multi center clinical trial, using lapatinib versus placebo, for the treatment of ductal carcinoma in situ breast cancer prior to surgical intervention.   The goals of the study are: 1) to compare the effect of women taking lapatinib at 1000 mg as compared to women taking placebo to determine whether lapatinib therapy substantially reduces proliferation of DCIS breast cancer cells in patients who are EGFR or Her2 Neu positive. 2) To determine the toxicity profile and frequency of adverse events in women with DCIS breast cancer taking lapatinib at 1000 mg as compared to women taking placebo.  3) To determine whether lapatinib treatment affects the incidence of DCIS Breast Cancer cells seen at time of surgical excision.  The results of this clinical trial will provide critical information to develop tyrosine kinase inhibitors as agents for the treatment and prevention of women with breast cancer in future clinical trials.

Phase: Phase II


Statin Polyp Prevention Trial in Patients with Resected Colon Cancer (Colorectal Polyp Prevention Trial)

Contact Number: 713-792-8064
Principal Investigator: Therese B. Bevers, M.D.
Status: Open to new patient accrual
Population: Patients diagnosed with Stage I or II colon cancer that has been removed by surgery within the past 12 months

Eligible:

  • Surgical resection  of the colon adenocarcinoma with curative intent within 1 year prior.
  • Chemotherapy, if given, must be completed before starting study.
  • Colonoscopy with removal of all observed polyps within 180 days prior to starting study.

Ineligible:

  • Patients who require cholesterol lowering agents or have a diagnosis of elevated cholesterol.
  • Total removal of colon.
  • Rectal cancers.

Brief Description: The goal of this study to learn if Crestor (rosuvastatin) is able to help prevent colon polyps from forming and/or colon cancer from returning in patients that have had colon cancer removed by surgery.  Crestor is a type of drug called a statin approved by the U.S. Food and Drug Administration (FDA) for lowering cholesterol.

Phase: Phase III randomized, double-blind study


A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer (DMP-1)

Contact Number: 713-792-8064
Principal Investigator: P Therese B. Bevers, M.D.
Status: Open to new patient accrual
Population: Women identified to be at increased risk for developing breast cancer who are given the option to take a Selective Estrogen Receptor Modulator (SERM) for breast cancer risk reduction during a counseling session.

Eligible:

  • Participants must be female and  >  35 year of age.
  • Participants must be identified as being at increased risk for breast cancer as determined by her health care provider.
  • During the participant’s counseling session, breast cancer risk and the use of SERMs for breast cancer risk reductions must have been discussed.

Ineligible:

  • Previous invasive breast cancer of any type or ductal carcinoma in situ (DCIS).
  • Participation in any other cancer prevention study involving pharmacologic interventions or osteoporosis prevention study involving pharmacologic interventions.
  • Any history of or current tamoxifen,  raloxifene, or other SERM therapy for any other reason.

Brief Description: This study will look at the social and psychological factors involved in making decisions about breast cancer risk reduction strategies.  In order to conduct the study, video recordings of the counseling sessions and individual interviews are combined with questionnaires to explore factors that influence women’s decisions about whether or not to take a SERM to reduce the risk of developing breast cancer.  

Phase: Exploratory, descriptive study


Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer

Contact Number: 713-792-8064
Principal Investigator: Therese B. Bevers, M.D.
Status: Closed to patient accrual- results published JAMA 295(23):2727-41, 2006
Population: Postmenopausal women 35 years of age or older who are at increased risk for the development of breast cancer

Brief Description: The primary aim of the study is to determine if raloxifene is either more or less effective than tamoxifen in reducing the incidence of invasive breast cancer in postmenopausal women who are at increased risk for developing breast cancer.  Eligible participants were assigned in this double-blind trial daily Tamoxifen 20mg plus placebo or Raloxifene 60mg plus placebo for a period of 5 years.

Phase: Phase III randomized, double-blind study


Phase 1b Randomized, Double-Blinded Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with a History of Hormone Receptor-Negative Breast Cancer

Contact Number: 713-792-8064
Principal Investigator: Therese B. Bevers, M.D.
Status: Closed to patient accrual — results pending

Brief Description: The goal of this clinical research study is to find the highest tolerable dose of the Polyphenon E (Poly E) that can be given to patients who have had hormone receptor-negative breast cancer. Another goal is to test the safety of Poly E at different dose levels.

Phase: Ib randomized, double-blind study


A Randomized Double Blind Placebo- Controlled Biomarker Modulations Study of High Dose Vitamin D in Premenopausal Women at High-risk for Breast Cancer

Contact Number: 713-792-8064
Principal Investigator: Therese B. Bevers, M.D.
Status: Open to new patient accrual
Population: Premenopausal women between 18 and 50 years of age identified to be at increased risk of developing breast cancer

Eligible:

  • Personal history of ductal carcinoma in situ or lobular carcinoma in situ OR
  • Known personal history of genetic mutation in BRCA 1, BRCA2, PTEN, or TP 53 OR
  • Elevated risk as determined by Gail Model.

Ineligible:

  • Prior history of invasive breast cancer.
  • Prior history of kidney stones.

Brief Description: The purpose of this study is to see if Vitamin D affects breast tissue by reducing breast tissue thickness (the amount of glandular breast issue compared to fat) on a mammogram (a special imaging exam of the breast that uses x-rays) and if it reduces the growth of breast cells to determine if it can be developed as a future option to prevent breast cancer.  Vitamin D is a natural vitamin supplement.

Phase: Phase IIb


Vitamin D and Breast Cancer Biomarkers

Contact Number: 713-792-8064
Principal Investigator: Therese B. Bevers, M.D.
Status: Approval Pending
Population: Premenopausal women between 18 and 55 years regardless risk of developing breast cancer

Eligible:

  • Premenopausal women 55 years of age or younger with regular menstrual cycles.
  • Women with breast density > 25% are eligible.

Ineligible:

  • Prior history of invasive breast cancer including ductal carcinoma in situ (DCIS).
  • Prior history of breast implants or breast reductions surgery.
  • Prior with a prior history of kidney stones, osteoporosis,  or hyperparathyroidism are not eligible.
  • Current participation in a breast cancer chemoprevention trial.

Brief Description: The purpose of this study is to see if Vitamin D affects breast tissue by reducing breast tissue thickness (density) on a mammogram (a special imaging exam of the breast that uses x-rays) and if it reduces the growth of breast cells to determine if it can be developed as a future option to prevent breast cancer.  Vitamin D is a natural vitamin supplement.

Phase: Phase IIb


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