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Protocol No. UW16083

Principal Investigator ORegan, Ruth

Phase II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer

Objective This research study looks at what effects restriction of methionine, an amino acid, from the diet before surgery will have on triple negative breast cancer. Triple negative breast cancer (TNBC) is a type of breast cancer that tests negative for estrogen receptors (ER-), progesterone receptors(PR-), and human epidermal growth factor receptor-2 (HER2-). Receptors are molecules that receive and respond to signals (such as hormones) from outside a cell. Testing negative for these receptors means that your cancer growth is not caused by the hormones estrogen or progesterone, or by having too many HER2 receptors. There is another kind of receptor expressed on cancer cells that is generally not active. Activation of these receptors can lead to death of cancer cells, so they are called "death receptors". We have found in mice that a diet low in methionine, an essential amino acid, can increase the number of active death receptors on triple negative breast cancers and can improve metabolic health.

Treatment You will take a low methionine diet, under the supervision of a registered dietitian, for 7 to 21-days prior to starting your scheduled therapy (surgery or chemotherapy). To test the effects of the study diet, the researchers need to collect samples of tumor tissue after you have been on the low-methionine diet. If you are scheduled to have surgery after the study diet, researchers will take some of the tissue left over from your surgery for research testing. This will not change how your surgery is performed. If you are scheduled to have chemotherapy after the study diet, we will do a breast biopsy to get the tumor tissue we need for research testing. This breast biopsy is for research purposes only and will be performed at no cost to you.

Description The diet will consist of beverages made with Hominex-2 along with a low methionine diet. Hominex-2 is a powder containing protein (except for the the amino acid methionine), fat, carbohydrates, vitamins, and minerals. You will drink 4 to 5 beverages made with Hominex-2 each day that will deliver 100% of your protein requirements and 40-50% of your caloric requirements. You will also eat and drink low-methionine foods, including fruits, fruit juices, vegetables, grains (such as some kinds of cereal, pasta, and bread), margarine, and cooking oils. We will provide you with a list of foods that are low in methionine as well as a few recipes using Hominex-2. Your total calorie intake will not be restricted. You can continue your usual exercise routine. Click here for more info

Key Eligibility
  • Patients must have histologically confirmed operable triple negative breast cancer
  • No prior therapy for current breast cancer
  • Operable breast cancer: Patients who are planned to undergo neo-adjuvant chemotherapy are eligible as long as they consent to an additional breast biopsy following the dietary intervention immediately prior to starting chemotherapy
  • Women age ≥18 years
  • Non-pregnant: Women of childbearing potential must have a negative pregnancy test to participate in this study
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will be excluded
  • Patients not able to swallow oral medications or with gastrointestinal conditions that may impact absorption of oral medications will be excluded
  • Patients who are receiving any other investigational agents will be excluded

Applicable Disease Sites Breast

Status Open

Participating Institutions UW Hospital and Clinics