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New treatment option for Anatomic Stage I Breast Cancer AJCC v8
Official title Neoadjuvant Breast Cancer Time Restricted Eating
ClinicalTrials.gov ID: NCT05327608
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Inclusion Criterion Individuals must meet all of the following in order to be eligible to participate in the study:
- 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.
You likely can't join 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...
- Patients with type 1 diabetes, or type 2 diabetes treated with insulin.
- Patients with a history of eating disorder or taking weight loss medications
See the full eligibility criteria
- Inclusion Criterion Individuals must meet all of the following in order to be eligible to participate in the study:
- 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.