Clinical trial · Interventional
NEOBREADS: Neoadjuvant Breast Diet Study
IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 2 years, though each patient's participation will be approximately 6 months.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbohydrate restricted dietary intervention | Other | — | UNRESOLVED |
| standard of care aromatase inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dietary intervention
- description
- Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors
- interventionNames
- Other: Carbohydrate restricted dietary intervention
- Drug: standard of care aromatase inhibitors
Primary outcomes (1)
- measure
- Diet adherence
- timeFrame
- 6 months
- description
- Proportion of patients able to consistently adhere to the low carbohydrate diet in combination with AIs during neo-adjuvant treatment. The patient will be considered adherent for each food diary if \<20% of calories were obtained from carbohydrates. This will be approximately 80 grams of carbohydrates but will vary depending on total caloric intake. A patient will be considered adherent to the diet overall if they meet the adherence cutoff at least 75% of the time (i.e. in at least 75% of food diaries for a single patient \<20% of calories were obtained from carbohydrates).
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed breast cancer; clinical T2-T4c, any N, M0 invasive breast cancer by AJCC 7th edition clinical staging, with goal being surgery to complete excision of tumor in the breast and lymph node. Primary tumor must be palpable, largest diameter \>2.0 cm by physical examination or by radiological assessment. * ER/PR+; defined as either ER and/or PR +, 1+ in 10% of cells * HER2 Negative; HER2 negative is defined by the following criteria: 1. 0 or 1+ by IHC and ISH not done 2. 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) \< 2 3. 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) \< 2 * Ability to read, write, and understand English * BMI \>24 kg/m2 * ECOG performance status 0-2 * Planning to receive neoadjuvant aromatase inhibitor therapy * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * Age \> 18 years Exclusion Criteria: * Already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet * Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study * Candidate for chemotherapy or HER2 directed therapy * Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy, or investigational agent prior to study entry (initiation of AI within 30 days of diet initiation acceptable) * Loss of \>10% of body weight within the previous 6 months * Clinical or radiographic evidence of metastatic disease. * Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
References
Publications (0)
Data not yet available