This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index (BMI) 25-40. TRE has been shown to elicit similar metabolic changes as calorie restriction such as reduction in blood glucose levels, improved insulin sensitivity, and reduction of tumor cell growth. TRE may improve outcomes in patients with breast cancer.
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 Eastern Cooperative Oncology Group (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
Short-Term Fasting
Other interventionUndergo TRE
Chemotherapy
DrugReceive standard of care neoadjuvant chemotherapy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Questionnaire Administration
Other interventionAncillary studies
Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days
The proportion of patients that adhere to TRE will be estimated with the corresponding exact binomial 90% confidence interval.
Pathologic complete response (pCR) rate
Will be estimated with corresponding the exact binomial 90% confidence intervals.
Percent of patients who maintain or have a reduced body mass index and waist circumference
Will be estimated with corresponding the exact binomial 90% confidence intervals.
Percent of patients who develop grade 3 or 4 toxicities
Will be assessed using Common Terminology Criteria for Adverse Event (CTCAE) version (v) 5.0.
Social determinants of health
Will be summarized descriptively for the entire study population and separately by the treatment received.
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