Time restricted eating for patients with HER2 negative breast cancer undergoing chemotherapy

Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy

This study is testing if following a time-restricted eating schedule can help women with HER2 negative breast cancer feel better and respond better to chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Thomas Jefferson University (Academic / other)
• Drugs / interventions: pembrolizumab, chemotherapy, radiation, doxorubicin, cytoxan
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05327608 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of time restricted eating (TRE) on patients with HER2 negative breast cancer who are starting neoadjuvant chemotherapy for stage I-III breast cancer. Participants will follow a 16:8 TRE schedule, fasting for 16 hours and eating during an 8-hour window, for 16 weeks while receiving treatment. The study aims to assess adherence to TRE, its impact on pathologic complete response rates, weight management, and the occurrence of severe toxicities. Additionally, it will explore differences in outcomes based on race and social determinants of health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a BMI between 25-40 and a recent diagnosis of HER2 negative stage I-III breast cancer.

Not a fit: Patients with a BMI outside the 25-40 range or those with HER2 positive breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and weight management for patients undergoing chemotherapy for breast cancer.

How similar studies have performed: While the specific approach of TRE in this context is novel, similar dietary interventions have shown promise in other cancer-related studies.

Eligibility criteria

Inclusion Criterion

Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:

1. Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent.
2. BMI 25-40 at time of enrollment.
3. Patients must have an ECOG performance status of 0 or 1.
4. Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma.

   1. Multifocal or contralateral DCIS or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER/PR and HER2.
   2. Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy.
5. Tumor status must be HER2 negative per ASCO/CAP guidelines (determined by local testing).
6. Patients must have clinical stage I-III (utilizing TNM criterion) at diagnosis.
7. 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.
8. 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.
9. Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician.
10. Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks
11. 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.
12. 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.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Clinical T4 and/or N3 disease, including inflammatory breast cancer.
2. Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.
3. 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.
4. Patients with type 1 diabetes, or type 2 diabetes treated with insulin.
5. Patients with a history of eating disorder or taking weight loss medications
6. Patients who actively smoke
7. Patients who work night shifts or on a rotating shift schedule.
8. Patients must not have impaired decision-making capacity.
9. Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool.
10. Patients that are \>2 weeks into starting neoadjuvant chemotherapy regimen.

Where this trial is running

Philadelphia, Pennsylvania

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Maysa Abu-Kalaf, MD

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