BREADS: Breast Adjuvant Diet Study

ClinicalTrials.gov ID: NCT04189263

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Official title

IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study

Brief summary

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

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 (such as heart rate, weight, and body measurement) and questionnaires 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. Total duration of the study is expected to be 3 years, though each patient's participation will be approximately 6 months.

Study identification

NCT ID: NCT04189263
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: Farin Amersi; Other
Enrollment: 6 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

Other · Drug

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: Feb 4, 2020 (Actual)
Primary completion: Mar 30, 2023 (Actual)
Completion: Mar 30, 2023 (Actual)
Last update posted: Apr 19, 2023

2020 – 2023

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 NCT04189263, 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 Apr 19, 2023 · Synced Nov 15, 2026