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Anatomic Stage I Breast Cancer AJCC v8NCT05327608

Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery

A study testing Short-Term Fasting, Chemotherapy and Biospecimen Collection in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Thomas Jefferson University at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Short-Term Fasting, Chemotherapy and Biospecimen Collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
5 sitesUnited States
Study dates
28 Jul 2022to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy
  • Patients must have clinical stage I-III (utilizing tumor, node, metastasis [TNM] criterion) at diagnosis
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  • Clinical T size must be >= 1.5 cm 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
  • 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

Who cannot join

  • 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
  • Patients who work on a rotating shift schedule
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  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Site Public Contact contact

215-600-9151

ONCTrialNow@jefferson.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

    Maysa Abu-Khalaf, MD, 215-955-8874

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Maysa Abu-Khalaf, MD, 215-955-8874, ONCTrialNow@jefferson.edu

    Maysa Abu-Khalaf, MD

    Recruiting

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

    Maysa Abu-Khalaf, MD, 215-955-8874

    Recruiting

  • Sidney Kimmel Cancer Center Washington Township, , NJ USA

    Sewell, New Jersey, 08080

    Maysa Abu-Khalaf, MD, 215-955-8874

    Recruiting

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

    Maysa Abu-Khalaf, MD, 215-955-8874

    Recruiting

Other trials in United States

About this study

Official title: Time Restricted Eating for Patients With Early Stage Breast Cancer Receiving Neoadjuvant Chemotherapy

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the proportion of patients that can adhere to TRE in patients with early stage breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer.

SECONDARY OBJECTIVES:

  1. To evaluate the pathologic complete response (pCR) rate of TRE in patients with early stage breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer.

II. To evaluate the effect of TRE in the weight management (prevention of weight gain), measured by BMI and waist circumference, in patients who are undergoing neoadjuvant chemotherapy.

III. To evaluate the percent of patients who develop Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 3 or 4 toxicities IV. To evaluate the differences in the pCR rate among breast cancer patients within different race/ethnic groups, African American versus (vs.) Non-Hispanic White (AA vs NHW) and based on baseline social determinants of health when undergoing NCT.

  1. To evaluate if study intervention acceptability, adherence, and engagement differ by race (AA vs NHW) and based on baseline social determinants of health.

VI. To evaluate if percent of patients with CTCAE version 5.0 grade 3 or 4 toxicities differ by race (AA vs NHW) and based on baseline social determinants of health.

EXPLORATORY OBJECTIVE:

  1. To monitor changes in the following inflammatory markers in patients undergoing neoadjuvant chemotherapy with TRE: fasting glucose, hemoglobin A1c, insulin, C-peptide, C-reactive protein (CRP), leptin, adiponectin, insulin-like growth factor 1 (IGF-1), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and free fatty acids and lipids.

OUTLINE:

Patients undergo TRE involving 16 hours of fasting and 8 hours of eating for 4 months while undergoing standard of care neoadjuvant chemotherapy. Patients also undergo blood sample collection on study.

After completion of study treatment, patients are followed up for 6 months.

Being tested
Short-Term Fasting, Chemotherapy, Biospecimen Collection, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short-Term FastingOther

    Also called Intermittent Fasting, Short-term Intermittent Fasting

    Undergo TRE

  • ChemotherapyDrug

    Also called Chemo, Chemotherapy (NOS), Cancer, General

    Receive standard of care neoadjuvant chemotherapy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample, Collection, Biospecimen, Collected, Biospecimen, Collection, Sample

    Undergo blood sample collection

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05327608
Study groupRoleWhat they receive
Treatment (TRE)ExperimentalPatients undergo TRE involving 16 hours of fasting and 8 hours of eating for 4 months while undergoing standard of care neoadjuvant chemotherapy. Patients also undergo blood sample collection on study.
Receives: Other: Short-Term Fasting; Drug: Chemotherapy; Procedure: Biospecimen Collection; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: While undergoing neoadjuvant chemotherapy

Secondary outcomes (7)

  1. Pathologic complete response (pCR) rate

    Will be estimated with corresponding the exact binomial 90% confidence intervals.

    Measured: Up to 4 months

  2. 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.

    Measured: Up to 4 months

  3. 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.

    Measured: Up to 4 months

  4. Social determinants of health

    Will be summarized descriptively for the entire study population and separately by the treatment received.

    Measured: Up to 4 months

  5. pCR rate among Non-Hispanic White patients

    Will be tabulated estimated with corresponding the exact binomial 90% confidence intervals for entire study population and separately by the treatment received.

    Measured: Up to 4 months

  6. Acceptability, adherence, and engagement of TRE among African American versus Non-Hispanic White breast cancer patients

    Measured: Up to 4 months

  7. Incidence of adverse events

    Will assess percent of patients with CTCAE v5.0 grade 3 or 4 toxicities differs among African American versus non-Hispanic White breast cancer patients.

    Measured: Up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start28 Jul 2022
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05327608
Sponsor's protocol ID
21D.625
Other IDs
JT 16674
Status last verified
Aug 2026
First submitted
13 Dec 2021
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Short-Term Fasting, Chemotherapy and Biospecimen Collection in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Thomas Jefferson University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Site Public Contact (215-600-9151, ONCTrialNow@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days (time frame: While undergoing neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05327608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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