Clinical Trials /

NEOBREADS: Neoadjuvant Breast Diet Study

NCT03822715

Description:

This is a randomized controlled trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via phone counseling with dietitian plus aromatase inhibitor therapy vs. 6-month control with aromatase inhibitor therapy alone. Visits will occur at screening, 3 months, and 6 months. Anthropomorphic measurements and patient reported outcomes (PROs) will be taken at all three visits. After screening, patients will be randomized to receive the carbohydrate restricted diet coaching immediately (Arm A) or to a control group (Arm B). Patients randomized to Arm A will receive weekly calls for the first 3 months of the intervention, then biweekly calls for the last 3 months of the intervention from the study dietitian. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 3 years, though each patient's participation will be approximately 6 months.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: NEOBREADS: Neoadjuvant Breast Diet Study
  • Official Title: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study

Clinical Trial IDs

  • ORG STUDY ID: IIT2018-25-MITA-NEOBREADS
  • NCT ID: NCT03822715

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
standard of care aromatase inhibitorsDietary intervention

Purpose

This is a randomized controlled trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via phone counseling with dietitian plus aromatase inhibitor therapy vs. 6-month control with aromatase inhibitor therapy alone. Visits will occur at screening, 3 months, and 6 months. Anthropomorphic measurements and patient reported outcomes (PROs) will be taken at all three visits. After screening, patients will be randomized to receive the carbohydrate restricted diet coaching immediately (Arm A) or to a control group (Arm B). Patients randomized to Arm A will receive weekly calls for the first 3 months of the intervention, then biweekly calls for the last 3 months of the intervention from the study dietitian. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 3 years, though each patient's participation will be approximately 6 months.

Trial Arms

NameTypeDescriptionInterventions
Dietary interventionExperimentalCarbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors
  • standard of care aromatase inhibitors
No dietary interventionActive ComparatorStandard of care aromatase inhibitors
  • standard of care aromatase inhibitors

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

          -  Accessible malignant breast tissue from biopsy

          -  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.

          -  Post-menopausal; defined as: The absence of menstrual cycles in women who have not
             undergone hysterectomy for at least 12 months preceding cancer diagnosis OR history of
             a bilateral oophorectomy OR history of a hysterectomy and age >55 OR no menses for <1
             year with FSH and estradiol levels in postmenopausal range according to institutional
             standards

          -  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 randomization 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:modified PEPI 0 score
Time Frame:6 months
Safety Issue:
Description:Difference in proportion of patients who have a modified PEPI 0 score at surgery between low-carb group and aromatase inhibitor only group.

Secondary Outcome Measures

Measure:Change in tumor size
Time Frame:6 months
Safety Issue:
Description:Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.
Measure:Change in Ki67
Time Frame:6 months
Safety Issue:
Description:Difference in change in Ki67 between pre-and post- intervention between carbohydrate restricted and control group.
Measure:Change in weight
Time Frame:6 months
Safety Issue:
Description:Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group.
Measure:Change in HbA1c
Time Frame:6 months
Safety Issue:
Description:Difference in change in HbA1c between pre- and post- intervention between carbohydrate restricted and control group.
Measure:Change in insulin
Time Frame:6 months
Safety Issue:
Description:Difference in change in insulin between pre- and post- intervention between carbohydrate restricted and control group.
Measure:Change in triglycerides
Time Frame:6 months
Safety Issue:
Description:Difference in change in triglycerides between pre- and post- intervention between carbohydrate restricted and control group.
Measure:Change in LDL cholesterol
Time Frame:6 months
Safety Issue:
Description:Difference in change in LDL cholesterol between pre- and post- intervention between carbohydrate restricted and control group.
Measure:Change in HDL cholesterol
Time Frame:6 months
Safety Issue:
Description:Difference in change in HDL cholesterol between pre- and post- intervention between carbohydrate restricted and control group.
Measure:Change in total cholesterol
Time Frame:6 months
Safety Issue:
Description:Difference in change in total cholesterol between pre- and post- intervention between carbohydrate restricted and control group.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Monica Mita

Trial Keywords

  • aromatase inhibitor
  • carbohydrate restricted diet

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