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Low accrual
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| Name | Class |
|---|---|
| Cedars-Sinai Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention | Experimental | Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate restricted dietary intervention | Other | Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tumor size | Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group. | 6 months |
| Mean change in Ki67 | Change in Ki67 between pre-and post- intervention |
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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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica Mita, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| standard of care aromatase inhibitors | Drug | standard of care aromatase inhibitors |
|
| 6 months |
| Mean change in weight | Change in weight between pre- and post- intervention | 6 months |
| Mean change in HbA1c | Change in HbA1c between pre- and post- intervention | 6 months |
| Mean change in insulin | Change in insulin between pre- and post- intervention | 6 months |
| Mean change in triglycerides | Change in triglycerides between pre- and post- intervention | 6 months |
| Mean change in LDL cholesterol | Change in LDL cholesterol between pre- and post- intervention | 6 months |
| Mean change in HDL cholesterol | Change in HDL cholesterol between pre- and post- intervention | 6 months |
| Mean change in total cholesterol | Change in total cholesterol between pre- and post- intervention | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |