Clinical trial · Interventional
A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer
NCT03186937CI-TRIAL-00053357terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding and slow enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hominex-2 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hominex-2
- description
- Participants will receive an individualized dietary prescription that incorporates a methionine-free amino acid-modified medical food (Hominex-2, Abbott Nutrition) supplemented with low-methionine foods. Hominex-2 contains a mixture of L-amino acids but lacks methionine. Participants will be asked to have an optional non-contrast MRI to assess body composition prior to and at completion of the methionine-restricted (MR) diet. Not completing a scheduled MRI is not considered a protocol deviation. Participants will be followed for 30 days after surgery or biopsy date. Subjects removed from study for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the AE.
- interventionNames
- Dietary Supplement: hominex-2
Primary outcomes (1)
- measure
- Change in cell surface expression of TRAIL receptor-2
- timeFrame
- Up to 3 weeks
- description
- To determine if methionine restriction can enhance the cell surface expression of TRAIL receptor-2 in triple negative breast cancers.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.