Is NCT05327608 recruiting in Sewell, NJ?

Yes, NCT05327608 is currently recruiting participants at its Sewell, NJ location. This anatomic stage i breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Sewell clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anatomic Stage I Breast Cancer AJCC v8 Clinical Trial in Sewell, NJ

Q: How do I join the anatomic stage i breast cancer ajcc v8 clinical trial in Sewell?

To join this clinical trial in Sewell, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Anatomic Stage I Breast Cancer AJCC v8 Study in Sewell

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. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+/- 5 days) by the research team during their clinic visit.

Sponsor: Thomas Jefferson University

Who Can Participate

Inclusion Criteria

Criterion Individuals must meet all of the following inclusion criteria 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 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.

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.

Exclusion Criteria

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 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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Sewell?

Yes, this clinical trial (NCT05327608) has an active research site in Sewell, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anatomic Stage I Breast Cancer AJCC v8 Treatment Options in Sewell, NJ

If you're searching for anatomic stage i breast cancer ajcc v8 treatment options in Sewell, NJ, this clinical trial (NCT05327608) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Sewell research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anatomic stage i breast cancer ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anatomic stage i breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage I Breast Cancer AJCC v8 Clinical Trial in Sewell, NJ

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