Refining Local-Regional Therapy for IBC (NCT04636710) | Clinical Trial Compass
RecruitingNot Applicable
Refining Local-Regional Therapy for IBC
United States50 participantsStarted 2021-06-02
Plain-language summary
This Feasibility study is trying to determine:
* If Lymphoscintigraphy (imaging of the lymphatic drainage patterns) is effective in demonstrating the drainage to the sentinel lymph nodes in patients with inflammatory breast cancer.
* The likelihood of identifying the sentinel lymph nodes in the operating room, using both blue dye and the radioactive substance used for lymphoscintigraphy.
* The incidence of lymphedema (arm swelling which occurs after lymph node surgery) in women with inflammatory breast cancer
* Outcomes for women with inflammatory breast cancer, whether or not the sentinel lymph nodes can be identified.
Who can participate
Age range
18 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:
* Stage III IBC (cT4d cN0-2). Inflammatory breast cancer is defined as the following constellation of symptoms (all of the following must be met):
* Rapid onset symptoms (6 months or less from time of diagnosis)
* Breast erythema, edema and/or peau d'orange and/or warm breast with or without an underlying palpable mass
* Erythema occupying at least one-third of the breast
* Pathologic confirmation (biopsy-proven) invasive breast carcinoma
* Women age ≥18 years
* ECOG performance status ≤2
* Ability to understand and willingness to sign informed consent document and comply with study procedures, including baseline research biopsy. If the research biopsy is not felt to be reasonably safe or feasible, a waiver must be obtained from the Principal Investigator. A formal exception would not be required in this case.
Exclusion Criteria:
* Participants who initiated pre-operative/neoadjuvant therapy prior to registration are ineligible.
* Participants with Stage IV (metastatic) breast cancer are excluded. The absence of any evidence of distant disease on staging studies needs to be confirmed at the time of diagnosis (within 42 days from initial presentation) using the staging studies that are standard for the participating institution.
* Participants with positive contralateral axillary nodes identified on standard imaging studies (MMG, MRI, US) are excluded. In participants with clinically suspicious axillary nodes, US guided biopsy will be performed …
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.