NEOBREADS: Neoadjuvant Breast Diet Study

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Other: Carbohydrate restricted dietary intervention; Drug: standard of care aromatase inhibitors

• Registration Number: NCT03822715
• Lead Sponsor: Monica Mita

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Study Start: 2019-03-21
• Status Verified: 2021-08
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-17
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary intervention	Carbohydrate restricted dietary intervention	Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors
Dietary intervention	standard of care aromatase inhibitors	Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 HbA1c	6 months	Change in HbA1c between pre- and post- intervention
Mean change in total cholesterol	6 months	Change in total cholesterol between pre- and post- intervention
Mean change in weight	6 months	Change in weight 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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States