NEOBREADS: Neoadjuvant Breast Diet Study

M

Monica Mita

Status and phase

Terminated
Phase 1

Conditions

Breast Cancer

Treatments

Drug: standard of care aromatase inhibitors
Other: Carbohydrate restricted dietary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03822715
IIT2018-25-MITA-NEOBREADS

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:

  • 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
  • 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

  • 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Dietary intervention
Experimental group
Description:
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors
Treatment:
Other: Carbohydrate restricted dietary intervention
Drug: standard of care aromatase inhibitors

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems