NEOBREADS: Neoadjuvant Breast Diet Study (NEOBREADS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Carbohydrate restricted dietary intervention; Drug: standard of care aromatase inhibitors

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dietary intervention; Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors	Other: Carbohydrate restricted dietary intervention; Carbohydrate restricted dietary intervention (<20 g carbohydrates/day); Drug: standard of care aromatase inhibitors; standard of care aromatase inhibitors

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Monica Mita
• Collaborators: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Monica Mita, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2019
• Primary Completion (ACTUAL): August 17, 2021
• Study Completion (ACTUAL): August 17, 2021

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: aromatase inhibitor; low carb diet; carbohydrate restricted diet; low-carb diet; neo-adjuvant treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Aromatase Inhibitors
• Other Study ID Numbers: IIT2018-25-MITA-NEOBREADS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No