A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+/- 5 days) by the research team during their clinic visit.
Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent.
BMI 25-40 at time of enrollment.
Patients must have an ECOG performance status of 0 or 1.
Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma.
Clinical T4 and/or N3 disease, including inflammatory breast cancer.
Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention.
Patients with type 1 diabetes, or type 2 diabetes treated with insulin.
Single group
Time Restricted Eating
Other interventionUndergo intermittent fasting
1. Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days
A patient's adherence will be measured as the percent (%) of days where a patient reports on the survey that they were able to complete at least 14 or more hours of fasting per 24 hours (each day) during 16 weeks (112 days) of neoadjuvant chemotherapy. A patient will be considered adherent to TRE if percent (%) of days where a patient reports on the survey that they were able to complete at least 14 or more hours of fasting per 24 hours (each day) during 16 weeks is 70% or higher. For patients who complete \< 16 weeks of chemotherapy from the date of starting TRE, adherence will be computed based on number of days of chemotherapy cycles received. If the proportion of days with confirmed TRE adherence is 70% or greater, then the patient is considered to have achieved overall TRE adherence.
Pathologic complete response (pCR) rate
Will be estimated with corresponding the exact binomial 90% confidence intervals.
To measure the percent of patients who maintain or have a reduced BMI and waist circumference after TRE and neoadjuvant chemotherapy.
percent of patients who maintain or have a reduced BMI and waist circumference after TRE and neoadjuvant chemotherapy.
To measure the percent of patients who develop CTCAE (v5.0) grade 3 of 4 toxicities
percent of patients who develop CTCAE (v5.0) grade 3 of 4 toxicities
To compare pCR rate among African American vs. Non-Hispanic White breast cancer patients and based on social determinants of health when undergoing TRE plus neoadjuvant chemotherapy.
pCR rate among African American vs. Non-Hispanic White breast cancer
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