NEOBREADS: Neoadjuvant Breast Diet Study

Study Overview
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Brief Summary
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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.

Official Title
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IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Carbohydrate restricted dietary intervention
* Drug: standard of care aromatase inhibitors


Participation Criteria
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Eligibility Criteria
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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: 0 or 1+ by IHC and ISH not done 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention<br>Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors | Other: Carbohydrate restricted dietary intervention<br>* Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)<br>Drug: standard of care aromatase inhibitors<br>* standard of care aromatase inhibitors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet adherence | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tumor size | Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group. | 6 months | 
| Mean change in Ki67 | Change in Ki67 between pre-and post- intervention | 6 months | 
| Mean change in weight | Change in weight between pre- and post- intervention | 6 months | 
| Mean change in HbA1c | Change in HbA1c between pre- and post- intervention | 6 months | 
| Mean change in insulin | Change in insulin between pre- and post- intervention | 6 months | 
| Mean change in triglycerides | Change in triglycerides between pre- and post- intervention | 6 months | 
| Mean change in LDL cholesterol | Change in LDL cholesterol between pre- and post- intervention | 6 months | 
| Mean change in HDL cholesterol | Change in HDL cholesterol between pre- and post- intervention | 6 months | 
| Mean change in total cholesterol | Change in total cholesterol between pre- and post- intervention | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatase inhibitor, carbohydrate restricted diet, neo-adjuvant treatment, low-carb diet, low carb diet