Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older at the time of signing consent, and who are able to understand and agree to participate.
• People with a body mass index (BMI) between 25 and 40 at the time of joining the study.
• People who are generally healthy and able to carry out daily activities with little to no limitation (this is measured using a standard medical scoring tool called ECOG — confirm with trial site).
• People who have recently been diagnosed with a primary invasive breast cancer, confirmed by a tissue sample (biopsy).
• People whose breast cancer tests negative for a protein called HER2, based on standard testing guidelines.
• People whose breast cancer has been classified as stage I, II, or III at the time of diagnosis.
• People whose tumour measures at least 1.5cm if there is no sign of cancer in the underarm lymph nodes, or any tumour size if the lymph nodes appear to be affected.
• People who are able and willing to receive at least 16 weeks of standard chemotherapy before surgery (the specific drugs used will be decided by the treating doctor).
• People whose organ and bone marrow function is considered suitable for starting chemotherapy, as assessed by their treating doctor.
• People who are willing and able to take part in a time-restricted eating (TRE) program for 16 weeks.
• People who are using an accepted and effective method of contraception, or who abstain from sex, for the full duration of the study and for 6 months after the last study activity (this applies to women who could become pregnant and to sexually active men).
• People who have a personal email address, a device that can access the internet, and who are willing and able to read and reply to emails every day throughout the study.

Who may not be able to join:

• People whose cancer is classified as T4 or N3 (meaning the tumour has grown into the chest wall or skin, or there is extensive lymph node involvement), or who have inflammatory breast cancer.
• People who have already received any treatment for their current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.
• People who are currently pregnant or breastfeeding, or who plan to become pregnant from the time of joining the study until at least 6 months after the last study activity.
• People who have type 1 diabetes, or type 2 diabetes that is managed with insulin.
• People who have a history of an eating disorder, or who are currently taking weight loss medications.
• People who currently smoke.
• People who work night shifts or rotating shift schedules.
• People who have difficulty making their own decisions or giving informed consent.
• People who do not speak English, as the study tools and support are currently only available in English.
• People who are more than 2 weeks into their chemotherapy treatment at the time of joining the study.

Important: Always verify eligibility with the trial site directly before applying.