Cancer Prevention Clinical Trials

Clinical Trials Conducted Through the iCAN PREVENT: MD Anderson International Cancer Prevention Clinical Trials Consortium

The Department of Clinical Cancer Prevention supports the National Cancer Institute and Division of Cancer Prevention clinical research by leading clinical trials in the Cancer Prevention Clinical Trials Network (CP-CTNet).

CP-CTNet trials are carried out across the United States and include Phase 0 (micro-dosing), Phase I (dose-finding), and Phase II (preliminary efficacy) multi-center clinical trials. Clinical Cancer Prevention leads such trials through its iCAN PREVENT: MD Anderson International Cancer Prevention Clinical Trials Consortium program.

Ruxolitinib for Premalignant Breast Disease

ClinicalTrials.gov ID NCT02928978

Brief Description: This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.

Study Contact

Parijatham Thomas, M.D.
Phone: 713-745-1075
Email: psthomas@mdanderson.org

Metformin and Nightly Fasting in Women With Early Breast Cancer 

ClinicalTrials.gov ID NCT05023967

Brief Description: This Phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight.

Publication in Cancer Prevention Research

MD Anderson Study Contact

Parijatham Thomas, M.D.
Phone: 713-745-1075
Email: psthomas@mdanderson.org

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

ClinicalTrials.gov ID NCT06184750

Brief Description: This Phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well-established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.

MD Anderson Study Contact

Parijatham Thomas, M.D.
Phone: 713-745-1075
Email: psthomas@mdanderson.org

Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients

ClinicalTrials.gov ID NCT05078866

Brief Description: This Phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of 50. In Lynch syndrome, errors in the genetic information inside cells are not properly corrected. When that happens, the cells produce new proteins called neoantigens. Neoantigens are recognized by the body's immune system as foreign, and the body tries to get rid of them. Nous-209 is a vaccine made with man-made copies of some of those neoantigens. This trial aims to see whether the Nous-209 vaccine is safe to give to patients with Lynch syndrome, whether people are able to take the Nous-209 vaccine without becoming too uncomfortable, and how the immune system of patients with Lynch syndrome respond to the Nous-209 vaccine. This trial may help researchers determine whether receiving Nous-209 have an effect on the development of polyps or tumors in the colon.

Publication in Nature Medicine

MD Anderson Study Contact

Eduardo Vilar-Sanchez, M.D., Ph.D.
Phone: 713-563-4743
Email: evilar@mdanderson.org

A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome

ClinicalTrials.gov ID NCT05411718

Brief Description: To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.

Study Contact

Eduardo Vilar-Sanchez, M.D.
Phone: 713-563-4743
Email: evilar@mdanderson.org

Testing Obeticholic Acid for Familial Adenomatous Polyposis

ClinicalTrials.gov ID NCT05223036

Brief Description: This Phase IIa trial investigates if giving obeticholic acid (OCA) is safe and has a beneficial effect on the number of polyps in the small bowel and colon in patients with familial adenomatous polyposis (FAP). FAP is a rare gene defect that increases the risk of developing cancer of the intestines and colon. OCA is a drug similar to a bile acid the body makes. It is fluid made and released by the liver. OCA binds to a receptor in the intestine that is believed to have a positive effect on preventing cancer development. OCA has been effective in treating primary biliary cholangitis (PBC), a liver disease, and is approved by the Food and Drug Administration (FDA) for use at a lower dose (10 mg). There have been studies showing that OCA decreases inflammation and fibrosis. However, it is not yet known whether OCA works on reducing the number of polyps in patients with FAP.

MD Anderson Study Contact

Eduardo Vilar-Sanchez, M.D., Ph.D.
Phone: 713-563-4743
Email: evilar@mdanderson.org

Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome

ClinicalTrials.gov ID NCT05419011

Brief Description: This Phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancers in participants with Lynch syndrome. Each of the three injections in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells. Injecting these substances may cause the immune system to develop a defense against cancer that recognizes and destroys any precancer and cancer cells that produce these proteins in the future. N-803 may increase immune responses to other vaccines. Giving Tri-Ad5 in combination with immune enhancing N-803 may lower the chance of developing colon and other cancers in participants with Lynch syndrome.

MD Anderson Study Contact

Eduardo Vilar-Sanchez, M.D., Ph.D.
Phone: 713-563-4743
Email: evilar@mdanderson.org

A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer

ClinicalTrials.gov ID NCT07349641

Brief Description: This Phase II trial studies whether adding tirzepatide injections to a levonorgestrel intrauterine device (LNG-IUD) improves pathologic response (absence of cancer cells in tissue samples after treatment) in women with endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) or grade 1 endometrial cancer who are overweight or obese. Endometrial cancer occurrence has continued to rise in the United States. Over half of endometrial cancer cases are thought to be attributable to being overweight and obese, and the risk relationship appears to be weight dependent. AH/EIN is a precancerous condition of the endometrium (the uterus or womb) where the lining of the uterus grows abnormally thick, and the cells become abnormal. Women with this thickening have a higher-than-average risk of developing endometrial cancer if left untreated. The usual approach for patients who have AH/EIN and grade 1 endometrial cancer is the removal of the uterus. While surgical treatment is generally safe and effective, it may not be the best approach for some patients. Tirzepatide injections are a type of glucagon-like peptide 1 (GLP-1) agonist which have been shown to drive weight loss. The LNG-IUD is a small, T-shaped device inserted into the uterus that releases the hormone levonorgestrel. Levonorgestrel is being studied in the prevention of endometrial cancer. Adding tirzepatide injections to LNG-IUD may help overweight or obese women with AH-EIN or grade 1 endometrial cancer lose weight, which may improve pathologic response.

MD Anderson Study Contact

Roni N. Wilke, M.D.
Phone: 713-822-4502
Email: RNitecki@mdanderson.org