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NEOBREADS: Neoadjuvant Breast Diet Study | Clinical Trials | Clareo Health

TERMINATEDPHASE1

NEOBREADS: Neoadjuvant Breast Diet Study

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

NCT03822715•Monica Mita

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+2 more criteria

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

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Key Dates

Start Date

March 21, 2019

Primary Completion Date

August 17, 2021

Completion Date

August 17, 2021

Last Updated

September 1, 2021

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Carbohydrate restricted dietary intervention

OTHER

standard of care aromatase inhibitors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NEOBREADS: Neoadjuvant Breast Diet Study

Inclusion Criteria

Exclusion Criteria

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