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Terminated Phase 1 Interventional

NEOBREADS: Neoadjuvant Breast Diet Study

ClinicalTrials.gov ID: NCT03822715

Public ClinicalTrials.gov record NCT03822715. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 19, 2026, 6:51 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03822715
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Monica Mita
Other
Enrollment
2 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 20, 2019
Primary completion
Aug 16, 2021
Completion
Aug 16, 2021
Last update posted
Aug 31, 2021

2019 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cedars-Sinai Medical Center Los Angeles California 90048

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03822715, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 31, 2021 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03822715 live on ClinicalTrials.gov.

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