Neoadjuvant Breast Cancer Time Restricted Eating

NCT05327608 | Recruiting DMC

• 2 other identifiers: 21D.625JT 16674
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Ductal Carcinoma in Situ; HER2 Negative Breast Carcinoma; Hormone Receptor Positive Breast Carcinoma; Invasive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  While undergoing neoadjuvant chemotherapy

Secondary Outcomes (6)

• Pathologic complete response (pCR) rate

  4 months

• To measure the percent of patients who maintain or have a reduced BMI and waist circumference after TRE and neoadjuvant chemotherapy.

  4 months

• To measure the percent of patients who develop CTCAE (v5.0) grade 3 of 4 toxicities

  4 months

• 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.

  4 months

• To measure the acceptability, adherence, and engagement of TRE among African American vs. Non-Hispanic White breast cancer patients and based on social determinants of health when undergoing neoadjuvant chemotherapy.

  4 months

Study Arms (1)

Treatment (Time Restricted Eating)

EXPERIMENTAL

This is a single arm, non-randomized trial. All participants will undergo TRE for 16 weeks while receiving NCT. For patients requiring NCT longer than 16 weeks, they can continue TRE however this will not be included in the main adherence calculations.

Other: Time Restricted Eating

Interventions

Time Restricted Eating OTHER

Undergo intermittent fasting

Also known as: Short-term Intermittent Fasting

Treatment (Time Restricted Eating)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Multifocal or contralateral DCIS or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER/PR and HER2.
• Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy.
• Tumor status must be HER2 negative per ASCO/CAP guidelines (determined by local testing).
• Patients must have clinical stage I-III (utilizing TNM criterion) at diagnosis.
• Clinical T size must be ≥ 1.5cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved.
• Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy.
• a. Acceptable regimen includes doxorubicin and cytoxan followed by a taxane The schedule will be determined by treating physician. Carboplatin and pembrolizumab can also be added to the neoadjuvant chemotherapy regimen if determined to be appropriate by treating physician.
• Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician.
• Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks
• Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention.
• Patient must have a personal email address, an internet-capable device, and the ability/ willingness to read and reply to email every day for the duration of the study.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• Patients with a history of eating disorder or taking weight loss medications
• Patients who actively smoke
• Patients who work night shifts or on a rotating shift schedule.
• Patients must not have impaired decision-making capacity.
• Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool.
• Patients that are \>2 weeks into starting neoadjuvant chemotherapy regimen.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Central Study Contacts

Maysa Abu-Kalaf, MD

CONTACT

215-955-8874; maysa.abu-khalaf@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: April 14, 2022
• Study Start: July 28, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)