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NEOBREADS: Neoadjuvant Breast Diet Study (NEOBREADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03822715
Recruitment Status : Terminated (Low accrual)
First Posted : January 30, 2019
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Monica Mita, Cedars-Sinai Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Carbohydrate restricted dietary intervention Drug: standard of care aromatase inhibitors Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
Actual Study Start Date : March 21, 2019
Actual Primary Completion Date : August 17, 2021
Actual Study Completion Date : August 17, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dietary intervention
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors
 Other: Carbohydrate restricted dietary intervention
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)

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


Outcome Measures
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Primary Outcome Measures :
  1. Diet adherence [ Time Frame: 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 :
  1. Change in tumor size [ Time Frame: 6 months ]
    Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.

  2. Mean change in Ki67 [ Time Frame: 6 months ]
    Change in Ki67 between pre-and post- intervention

  3. Mean change in weight [ Time Frame: 6 months ]
    Change in weight between pre- and post- intervention

  4. Mean change in HbA1c [ Time Frame: 6 months ]
    Change in HbA1c between pre- and post- intervention

  5. Mean change in insulin [ Time Frame: 6 months ]
    Change in insulin between pre- and post- intervention

  6. Mean change in triglycerides [ Time Frame: 6 months ]
    Change in triglycerides between pre- and post- intervention

  7. Mean change in LDL cholesterol [ Time Frame: 6 months ]
    Change in LDL cholesterol between pre- and post- intervention

  8. Mean change in HDL cholesterol [ Time Frame: 6 months ]
    Change in HDL cholesterol between pre- and post- intervention

  9. Mean change in total cholesterol [ Time Frame: 6 months ]
    Change in total cholesterol between pre- and post- intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822715


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Monica Mita
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Monica Mita, MD Cedars-Sinai Medical Center
More Information
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Responsible Party: Monica Mita, Professor, Medicine, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03822715    
Other Study ID Numbers: IIT2018-25-MITA-NEOBREADS
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monica Mita, Cedars-Sinai Medical Center:
aromatase inhibitor
carbohydrate restricted diet
neo-adjuvant treatment
low-carb diet
low carb diet
Additional relevant MeSH terms:
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Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs