<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822715</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2018-25-MITA-NEOBREADS</org_study_id>
    <nct_id>NCT03822715</nct_id>
  </id_info>
  <brief_title>NEOBREADS: Neoadjuvant Breast Diet Study</brief_title>
  <acronym>NEOBREADS</acronym>
  <official_title>IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Monica Mita</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total&#xD;
      carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur&#xD;
      at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported&#xD;
      outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at&#xD;
      their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of&#xD;
      the intervention. All subjects will receive surgery after approximately 6 months of&#xD;
      intervention. Total duration of the study is expected to be 2 years, though each patient's&#xD;
      participation will be approximately 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low accrual&#xD;
  </why_stopped>
  <start_date type="Actual">March 21, 2019</start_date>
  <completion_date type="Actual">August 17, 2021</completion_date>
  <primary_completion_date type="Actual">August 17, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diet adherence</measure>
    <time_frame>6 months</time_frame>
    <description>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 &lt;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 &lt;20% of calories were obtained from carbohydrates).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in tumor size</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Ki67</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Ki67 between pre-and post- intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in weight</measure>
    <time_frame>6 months</time_frame>
    <description>Change in weight between pre- and post- intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>Change in HbA1c between pre- and post- intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in insulin</measure>
    <time_frame>6 months</time_frame>
    <description>Change in insulin between pre- and post- intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in triglycerides</measure>
    <time_frame>6 months</time_frame>
    <description>Change in triglycerides between pre- and post- intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in LDL cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>Change in LDL cholesterol between pre- and post- intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in HDL cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>Change in HDL cholesterol between pre- and post- intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in total cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>Change in total cholesterol between pre- and post- intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Dietary intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carbohydrate restricted dietary intervention (&lt;20 g carbohydrates/day) + standard of care aromatase inhibitors</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Carbohydrate restricted dietary intervention</intervention_name>
    <description>Carbohydrate restricted dietary intervention (&lt;20 g carbohydrates/day)</description>
    <arm_group_label>Dietary intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>standard of care aromatase inhibitors</intervention_name>
    <description>standard of care aromatase inhibitors</description>
    <arm_group_label>Dietary intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed breast cancer; clinical T2-T4c, any N, M0 invasive breast&#xD;
             cancer by AJCC 7th edition clinical staging, with goal being surgery to complete&#xD;
             excision of tumor in the breast and lymph node. Primary tumor must be palpable,&#xD;
             largest diameter &gt;2.0 cm by physical examination or by radiological assessment.&#xD;
&#xD;
          -  ER/PR+; defined as either ER and/or PR +, 1+ in 10% of cells&#xD;
&#xD;
          -  HER2 Negative; HER2 negative is defined by the following criteria:&#xD;
&#xD;
               1. 0 or 1+ by IHC and ISH not done&#xD;
&#xD;
               2. 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) &lt; 2&#xD;
&#xD;
               3. 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) &lt; 2&#xD;
&#xD;
          -  Ability to read, write, and understand English&#xD;
&#xD;
          -  BMI &gt;24 kg/m2&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Planning to receive neoadjuvant aromatase inhibitor therapy&#xD;
&#xD;
          -  Written informed consent obtained from subject and ability for subject to comply with&#xD;
             the requirements of the study.&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already consuming a severely carbohydrate-restricted (i.e. &lt;20g total carbohydrates&#xD;
             per day) or vegetarian diet&#xD;
&#xD;
          -  Medical comorbidities that in the opinion of the investigator limits the patient's&#xD;
             ability to complete this study&#xD;
&#xD;
          -  Candidate for chemotherapy or HER2 directed therapy&#xD;
&#xD;
          -  Treatment for this cancer including surgery, radiation therapy, chemotherapy,&#xD;
             biotherapy, hormonal therapy, or investigational agent prior to study entry&#xD;
             (initiation of AI within 30 days of diet initiation acceptable)&#xD;
&#xD;
          -  Loss of &gt;10% of body weight within the previous 6 months&#xD;
&#xD;
          -  Clinical or radiographic evidence of metastatic disease.&#xD;
&#xD;
          -  Current use of weight loss medications including herbal weight loss supplements or&#xD;
             enrolled in a diet/weight loss program&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Mita, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 27, 2021</last_update_submitted>
  <last_update_submitted_qc>August 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Monica Mita</investigator_full_name>
    <investigator_title>Professor, Medicine</investigator_title>
  </responsible_party>
  <keyword>aromatase inhibitor</keyword>
  <keyword>carbohydrate restricted diet</keyword>
  <keyword>neo-adjuvant treatment</keyword>
  <keyword>low-carb diet</keyword>
  <keyword>low carb diet</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aromatase Inhibitors</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822715
org study id: IIT2018-25-MITA-NEOBREADS
nct id: NCT03822715
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Diet adherence
time frame: 6 months
description: 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).
measure: Change in tumor size
time frame: 6 months
description: Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.
measure: Mean change in Ki67
time frame: 6 months
description: Change in Ki67 between pre-and post- intervention
measure: Mean change in weight
time frame: 6 months
description: Change in weight between pre- and post- intervention
measure: Mean change in HbA1c
time frame: 6 months
description: Change in HbA1c between pre- and post- intervention
measure: Mean change in insulin
time frame: 6 months
description: Change in insulin between pre- and post- intervention
measure: Mean change in triglycerides
time frame: 6 months
description: Change in triglycerides between pre- and post- intervention
measure: Mean change in LDL cholesterol
time frame: 6 months
description: Change in LDL cholesterol between pre- and post- intervention
measure: Mean change in HDL cholesterol
time frame: 6 months
description: Change in HDL cholesterol between pre- and post- intervention
measure: Mean change in total cholesterol
time frame: 6 months
description: Change in total cholesterol between pre- and post- intervention
arm group label: Dietary intervention
arm group type: Experimental
description: Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors
intervention type: Other
intervention name: Carbohydrate restricted dietary intervention
description: Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)
arm group label: Dietary intervention
intervention type: Drug
intervention name: standard of care aromatase inhibitors
description: standard of care aromatase inhibitors
arm group label: Dietary intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Monica Mita, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Monica Mita
investigator title: Professor, Medicine
mesh term: Aromatase Inhibitors