NEOBREADS: Neoadjuvant Breast Diet Study
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | March 21, 2019 |
| End Date: | June 2022 |
| Contact: | Dana Levin, MPH |
| Email: | Dana.Levin@cshs.org |
| Phone: | 310-423-0333 |
IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast 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 and patient reported outcomes (PROs) 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. All subjects will receive surgery after approximately 6 months of intervention.
Total duration of the study is expected to be 3 years, though each patient's participation
will be approximately 6 months.
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 and patient reported outcomes (PROs) 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. All subjects will receive surgery after approximately 6 months of intervention.
Total duration of the study is expected to be 3 years, though each patient's participation
will be approximately 6 months.
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:
1. 0 or 1+ by IHC and ISH not done
2. 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2
3. 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
- Ability to read, write, and understand English
- BMI >24 kg/m2
- Accessible malignant breast tissue from biopsy
- 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.
- Post-menopausal; defined as: 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
- Age > 18 years
Exclusion Criteria:
- 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 randomization 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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Monica Mita, MD
Phone: 310-423-0333
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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