Breast CancerPhase 2NCT04189263
BREADS: Breast Adjuvant Diet Study
A Phase 2 study testing Carbohydrate restricted dietary intervention in people with Breast Cancer, run by Farin Amersi at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carbohydrate restricted dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 30 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed breast cancer
- Planning to start adjuvant hormonal therapy using an aromatase inhibitor or has started adjuvant hormonal therapy using an aromatase inhibitor
- Able to read, write, and understand English
- BMI ≥ 24 kg/m2
- Age ≥ 18 years
- ER and/or PR positive (defined as having ≥ 1% staining for ER and/or PR on IHC)
Show all 14Show fewer
- Post-menopausal
- The absence of menstrual cycles in women who have not undergone hysterectomy for at least 12 months preceding cancer diagnosis OR
- History of a bilateral oophorectomy OR
- History of a hysterectomy and age >55 OR
- No menses for <1 year with FSh and estradiol levels in postmenopausal range according to institutional standards
- ECOG Performance Status 0 or 1
- Female
- Written informed consent obtained from subject and ability for subject to comply with requirements of the study
Who cannot join
- Use of hormonal therapy other than aromatase inhibitors
- History of other malignancy within the past 5 years, except for malignancies with a > 95% likelihood of cure (e.g. thyroid cancer, non-melanoma skin cancer)
- Already consuming a severe carbohydrate restricted (<20 g carbohydrates per day) diet or vegetarian diet
- Currently on or plans to start chemotherapy (HER2/neu targeted therapy okay)
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete the study
- Symptomatic metastases (Metastases allowed if asymptomatic)
- Current use of appetite suppressant medications
- Current use of any weight loss medications including herbal weight loss supplements or if patients are enrolled in a diet/weight loss program
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study
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.
- Conditions
- Breast Cancer
- Being tested
- Carbohydrate restricted dietary intervention, standard of care aromatase inhibitors
- Keywords
- aromatase inhibitor, carbohydrate restricted diet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate restricted dietary interventionOther
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)
standard of care aromatase inhibitorsDrug
standard of care aromatase inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors Receives: Other: Carbohydrate restricted dietary intervention; Drug: standard of care aromatase inhibitors |
| No dietary intervention | Active comparator | Standard of care aromatase inhibitors Receives: Drug: standard of care aromatase inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in weight
Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group
Measured: 6 months
Secondary outcomes (8)
Changes in serum estradiol
Difference in changes in serum estradiol between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Changes in fasting glucose
Difference in changes in fasting glucose between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Changes in insulin
Difference in changes in insulin between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Changes in HbA1c
Difference in changes in HbA1c between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Changes in triglycerides
Difference in changes in triglycerides between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Changes in LDL
Difference in changes in LDL between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Changes in HDL
Difference in changes in HDL between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Changes in cholesterol
Difference in changes in cholesterol between pre- and post-intervention between low-carbohydrate group and control group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start4 Feb 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: Low participant compliance, slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farin Amersi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Farin Amersi, Cedars-Sinai Medical Center
- Investigators
- Farin Amersi, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189263
- Sponsor's protocol ID
- IIT2018-21-AMERSI-BREADS
- Status last verified
- Apr 2023
- First submitted
- 4 Dec 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study
- ClinicalTrials.gov ID
- NCT04189263
- Acronym / sponsor ID
- IIT2018-21-AMERSI-BREADS
- Conditions
- Breast Cancer
- Keywords
- aromatase inhibitor, carbohydrate restricted diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low participant compliance, slow recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Farin AmersiUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: Carbohydrate restricted dietary intervention, Drug: standard of care aromatase inhibitorsCarbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors |
| No dietary intervention | Active comparator | Drug: standard of care aromatase inhibitorsStandard of care aromatase inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed breast cancer
- Planning to start adjuvant hormonal therapy using an aromatase inhibitor or has started adjuvant hormonal therapy using an aromatase inhibitor
- Able to read, write, and understand English
- BMI ≥ 24 kg/m2
- Age ≥ 18 years
Key exclusion criteria (8 listed)
- Use of hormonal therapy other than aromatase inhibitors
- History of other malignancy within the past 5 years, except for malignancies with a > 95% likelihood of cure (e.g. thyroid cancer, non-melanoma skin cancer)
- Already consuming a severe carbohydrate restricted (<20 g carbohydrates per day) diet or vegetarian diet
- Currently on or plans to start chemotherapy (HER2/neu targeted therapy okay)
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate restricted dietary interventionCarbohydrate restricted dietary intervention (<20 g carbohydrates/day) | Other | Dietary intervention |
| standard of care aromatase inhibitorsstandard of care aromatase inhibitors | Drug | Dietary intervention, No dietary intervention |
Primary outcome
Mean change in weight
Time frame: 6 months
Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group
8 secondary outcomes
Changes in serum estradiol
Time frame: 6 months
Changes in fasting glucose
Time frame: 6 months
Changes in insulin
Time frame: 6 months
Changes in HbA1c
Time frame: 6 months
Changes in triglycerides
Time frame: 6 months
Changes in LDL
Time frame: 6 months
Changes in HDL
Time frame: 6 months
Changes in cholesterol
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Low participant compliance, slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farin Amersi, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbohydrate restricted dietary intervention in people with Breast Cancer, run by Farin Amersi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low participant compliance, slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.