Actively Recruiting
Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy
Led by Thomas Jefferson University · Updated on 2025-08-01
55
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Time Restricted Eating (TRE) in patients diagnosed with HER2-negative breast cancer who are starting neoadjuvant chemotherapy (NCT) for stage I-III disease. This phase II study aims to see how well patients can stick to a TRE schedule during chemotherapy and to explore effects on treatment response, weight management, and side effects. Differences in outcomes among racial groups and social factors are also being studied. All participants will follow a TRE 16:8 schedule, fasting for 16 hours and eating during an 8-hour window, for 16 weeks while receiving NCT. If patients find this challenging early on, they may modify the fasting time or switch to a 14:10 schedule. For those needing chemotherapy beyond 16 weeks, TRE continuation is encouraged but extra fasting data will be tracked separately. This is a single-arm study where all patients receive the same TRE intervention alongside their chemotherapy. Participants will report their adherence daily through electronic surveys and during clinic visits every 2-3 weeks. Researchers will monitor treatment response rates, changes in body mass index and waist size, and any severe chemotherapy side effects. They will also analyze biological markers related to inflammation and metabolism using blood samples and tissue biopsies taken before and after the TRE plus chemotherapy period. Participation duration is at least 16 weeks with ongoing follow-up for those continuing TRE longer.
CONDITIONS
Brief Title
Neoadjuvant Breast Cancer Time Restricted Eating
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older and able to provide informed consent
- Body mass index (BMI) between 25 and 40 at enrollment
- ECOG performance status of 0 or 1
- Recent diagnosis of histologically confirmed primary invasive breast carcinoma
- Multifocal or contralateral DCIS or invasive breast cancers allowed if ER/PR and HER2 status match
- Oligometastatic disease allowed if neoadjuvant chemotherapy is recommended
- Tumor must be HER2 negative according to local testing
- Clinical stage I to III breast cancer at diagnosis
- Tumor size at least 1.5 cm if no lymph node involvement; any size if lymph nodes involved
- Willing and able to receive standard neoadjuvant chemotherapy for at least 16 weeks
- Adequate organ and marrow function for chemotherapy
- Willing and able to participate in 16 weeks of Time Restricted Eating
- Women of childbearing potential and sexually active males must use effective contraception or abstain during study and for 6 months after
- Must have personal email, internet-capable device, and ability to read and respond to emails daily during study
You will not qualify if you...
- Clinical T4 or N3 disease, including inflammatory breast cancer
- Prior treatment for current breast cancer diagnosis (surgery, chemotherapy, radiation, experimental therapy)
- Pregnant or breastfeeding women, or those planning to conceive during study and 6 months after
- Type 1 diabetes or insulin-treated type 2 diabetes
- History of eating disorder or use of weight loss medications
- Active smokers
- Work night shifts or rotating shift schedules
- Impaired decision-making capacity
- Non-English speakers
- More than 2 weeks into neoadjuvant chemotherapy at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks or longer if chemotherapy continues
Participants undergo Time Restricted Eating (TRE) while receiving neoadjuvant chemotherapy for their breast cancer diagnosis.
Visits aligned with chemotherapy schedule during 16 weeks
Trial Site Locations
Total: 1 location
1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
M
Maysa Abu-Kalaf, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here