Clinical trial NCT03822715: NEOBREADS: Neoadjuvant Breast Diet Study
Official title: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: aromatase inhibitor
carbohydrate restricted diet
neo-adjuvant treatment
low-carb diet
low carb diet
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2019-01-30
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diet adherence
timeFrame: 6 months
Secondary outcomes:
measure: Change in tumor size
timeFrame: 6 months
measure: Mean change in Ki67
timeFrame: 6 months
measure: Mean change in weight
timeFrame: 6 months
measure: Mean change in HbA1c
timeFrame: 6 months
measure: Mean change in insulin
timeFrame: 6 months
measure: Mean change in triglycerides
timeFrame: 6 months
measure: Mean change in LDL cholesterol
timeFrame: 6 months
measure: Mean change in HDL cholesterol
timeFrame: 6 months
measure: Mean change in total cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Monica Mita, MD
role: PRINCIPAL_INVESTIGATOR
References: