NEOBREADS: Neoadjuvant Breast Diet Study

Sponsor

Monica Mita (Other)

Overall Status

Terminated

CT.gov ID

NCT03822715

Collaborator

Cedars-Sinai Medical Center (Other)

Enrollment

Location

Arm

28.9

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Carbohydrate restricted dietary intervention Drug: standard of care aromatase inhibitors	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 21, 2019

Actual Primary Completion Date :

Aug 17, 2021

Actual Study Completion Date :

Aug 17, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Diet adherence [6 months]
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 Outcome Measures

Change in tumor size [6 months]
Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.
Mean change in Ki67 [6 months]
Change in Ki67 between pre-and post- intervention
Mean change in weight [6 months]
Change in weight between pre- and post- intervention
Mean change in HbA1c [6 months]
Change in HbA1c between pre- and post- intervention
Mean change in insulin [6 months]
Change in insulin between pre- and post- intervention
Mean change in triglycerides [6 months]
Change in triglycerides between pre- and post- intervention
Mean change in LDL cholesterol [6 months]
Change in LDL cholesterol between pre- and post- intervention
Mean change in HDL cholesterol [6 months]
Change in HDL cholesterol between pre- and post- intervention
Mean change in total cholesterol [6 months]
Change in total cholesterol between pre- and post- intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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