CompletedNot Applicable

Axillary Reverse Mapping in Breast Cancer

Spain43 participantsStarted 2021-06-01

Plain-language summary

The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema. A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.

Who can participate

Age range

18 Years

Sex

ALL

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: Patients who will undergo ALND in the treatment of breast cancer: * cT4a, cT4c and cT4d. * cT4b with extensive involvement of the skin. * cN0 with SLNB positive (pN+) that need to associate ALND: * cT3-T4b. * \>2 lymph node macrometastasis if cTis, cT1 and cT2. * Patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy. * cN1: * If primary surgery treatment. * After neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or SLNB positive (ypN+). * cN2: * If primary surgery treatment. * After neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or HER2 overexpressed tumours. * cN3. Exclusion Criteria: * Patients with previous axillary surgery (except sentinel node biopsy) * Patients who did previous axillary radiotherapy treatment. * Patients who do not wish to participate in the study.

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.

What they're measuring

Rate of patients who it is possible preserve ARM nodes

Timeframe: 1 year

Trial details

NCT IDNCT05040685

SponsorHospital Universitari de Bellvitge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

View on ClinicalTrials.gov More Lymph Node Cancer Metastatic trials