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

Stopped early · Phase 2

Conditions studied: Breast Cancer, Triple Negative Breast Cancer

In brief

Given preliminary data demonstrating that methionine deprivation enhances cell surface expression of TRAIL receptor-2, the objective of this clinical trial is to confirm that methionine restriction enhances its expression in triple negative breast cancer and to establish the feasibility and acceptability of this dietary intervention in humans. This study will also examine the effect of methionine restriction on cancer stem cells and metabolic health.

Key facts

Study ID

NCT03186937

Run by

University of Wisconsin, Madison

People needed

6

Starts

2017-08-10

Expected to finish

2019-06-21

Last updated by the study team

2021-08-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically confirmed operable triple negative breast cancer
• ER (estrogen receptors) and PR (progesterone receptors) expression must be < 2%
• HER2 must negative as shown be either 0 or 1+ by immunohistochemistry (if 2+, in situ hybridization method used to define HER2) OR by a HER2: 17 centromere signal of <2.0 using a standard in situ hybridization method.
• No prior therapy for current breast cancer
• Operable breast cancer. Participants 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
• ECOG (Eastern Cooperative Oncology Group) performance status ≤1
• Ability to understand and the willingness to sign a written informed consent document
• Serum creatinine <ULN (upper limit of normal)
• Non-pregnant. Women of childbearing potential must have a negative pregnancy test to participate in this study
• Women of childbearing potential must agree to use effective contraceptives (as discussed with their physician) while participating in this study

You may not qualify if…

• Patients who are receiving any other investigational agents
• Patients not able to swallow oral medications or with gastrointestinal conditions that may impact absorption of oral medications
• 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.

Where it is running

• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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