Radiation After No Axillary Nodal Sampling (NCT07723209) | Clinical Trial Compass
RecruitingNot Applicable
Radiation After No Axillary Nodal Sampling
United States105 participantsStarted 2026-07-09
Plain-language summary
This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.
Who can participate
Age range
40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals assigned Female at birth, age 40 and older
* Breast conserving surgery without SLNB or ALND
* All patients should be capable of giving informed consent,
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
* Histologically confirmed invasive ductal carcinoma
* Individuals with pathologic tumor size \<3cm
* Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial.
* Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging)
* Electrocorticography (ECOG) performance status 0-2
Exclusion Criteria:
* Male
* Transgender or non-binary individuals.
* Mastectomy
* Metastatic disease
* History of ipsilateral or contralateral breast cancer.
* Obstacles to obtaining informed consent or undergoing regular follow-up
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.