Breast CancerPhase 1NEOBREADSNCT03822715
NEOBREADS: Neoadjuvant Breast Diet Study
A Phase 1 study testing Carbohydrate restricted dietary intervention in people with Breast Cancer, run by Monica Mita at 1 site in United States.
Trial 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. 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
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 17 Aug 2021
- Phase
- Phase 1
- 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; 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:
- 0 or 1+ by IHC and ISH not done
- 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2
- 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
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- 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
Who cannot join
- 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
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: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
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.
- Conditions
- Breast Cancer
- Being tested
- Carbohydrate restricted dietary intervention, standard of care aromatase inhibitors
- Keywords
- aromatase inhibitor, carbohydrate restricted diet, neo-adjuvant treatment, low-carb diet, low carb 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet adherence
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).
Measured: 6 months
Secondary outcomes (9)
Change in tumor size
Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.
Measured: 6 months
Mean change in Ki67
Change in Ki67 between pre-and post- intervention
Measured: 6 months
Mean change in weight
Change in weight between pre- and post- intervention
Measured: 6 months
Mean change in HbA1c
Change in HbA1c between pre- and post- intervention
Measured: 6 months
Mean change in insulin
Change in insulin between pre- and post- intervention
Measured: 6 months
Mean change in triglycerides
Change in triglycerides between pre- and post- intervention
Measured: 6 months
Mean change in LDL cholesterol
Change in LDL cholesterol between pre- and post- intervention
Measured: 6 months
Mean change in HDL cholesterol
Change in HDL cholesterol between pre- and post- intervention
Measured: 6 months
Mean change in total cholesterol
Change in total cholesterol between pre- and post- intervention
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 posted30 Jan 2019
- Study start21 Mar 2019
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Why it stopped: Low accrual
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monica Mita
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor-investigator, Monica Mita, Cedars-Sinai Medical Center
- Investigators
- Monica Mita, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822715
- Sponsor's protocol ID
- IIT2018-25-MITA-NEOBREADS
- Acronym
- NEOBREADS
- Status last verified
- Aug 2021
- First submitted
- 25 Jan 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
- ClinicalTrials.gov ID
- NCT03822715
- Acronym / sponsor ID
- NEOBREADS / IIT2018-25-MITA-NEOBREADS
- Conditions
- Breast Cancer
- Keywords
- aromatase inhibitor, carbohydrate restricted diet, neo-adjuvant treatment, low-carb diet, low carb diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Monica MitaUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 30 Jan 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Ability to read, write, and understand English
- BMI >24 kg/m2
Key exclusion criteria (7 listed)
- 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
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 |
Primary outcome
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).
9 secondary outcomes
Change in tumor size
Time frame: 6 months
Mean change in Ki67
Time frame: 6 months
Mean change in weight
Time frame: 6 months
Mean change in HbA1c
Time frame: 6 months
Mean change in insulin
Time frame: 6 months
Mean change in triglycerides
Time frame: 6 months
Mean change in LDL cholesterol
Time frame: 6 months
Mean change in HDL cholesterol
Time frame: 6 months
Mean change in total cholesterol
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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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.
Monica Mita, 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 1 study testing Carbohydrate restricted dietary intervention in people with Breast Cancer, run by Monica Mita 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 12 inclusion and 7 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 1 Sep 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 accrual). 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?
Diet adherence (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 1 Sep 2021.