NEOBREADS: Neoadjuvant Breast Diet Study

Breast Cancer Clinical Trial

— NEOBREADS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03822715
• Other study ID #: IIT2018-25-MITA-NEOBREADS
• Status: Terminated
• Phase: Phase 1
• Start date: March 21, 2019
• Est. completion date: August 17, 2021

Study information

• Verified date: August 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Carbohydrate restricted dietary intervention
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)

Drug:
• standard of care aromatase inhibitors
standard of care aromatase inhibitors

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Monica Mita	Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in tumor size	Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.	6 months
Secondary	Mean change in Ki67	Change in Ki67 between pre-and post- intervention	6 months
Secondary	Mean change in weight	Change in weight between pre- and post- intervention	6 months
Secondary	Mean change in HbA1c	Change in HbA1c between pre- and post- intervention	6 months
Secondary	Mean change in insulin	Change in insulin between pre- and post- intervention	6 months
Secondary	Mean change in triglycerides	Change in triglycerides between pre- and post- intervention	6 months
Secondary	Mean change in LDL cholesterol	Change in LDL cholesterol between pre- and post- intervention	6 months
Secondary	Mean change in HDL cholesterol	Change in HDL cholesterol between pre- and post- intervention	6 months
Secondary	Mean change in total cholesterol	Change in total cholesterol between pre- and post- intervention	6 months