Active — Not RecruitingNot Applicable

Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment

Sweden114 participantsStarted 2020-01-01

Plain-language summary

The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration. For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST. The main points to investigate are: 1. If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection 2. If the nodal yield and the accuracy of the procedure are affected

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients with non-metastatic primary breast cancer and cN0/cN1 axilla, as defined by clinical examination and axillary ultrasound (with fine needle aspiration or core biopsy verification of metastasis) intended for PST (chemotherapy, targeted treatment or endocrine therapy) with a curative intention at diagnosis, Exclusion Criteria: * Distant metastases at diagnosis * Inflammatory breast cancer * Tumor progression during PST for cN1 patients * ycN1 after completion of PST * surgery before the completion of PST for any reason (PST adverse effects, patient preference) * cN1-to-ycN0 patients that opted for ALND

What they're measuring

Correlation between concordance (isotope and SPIO) and timepoint of SPIO administration to surgery

Timeframe: At surgery

Detection rate

Timeframe: At surgery

Concordance

Timeframe: At surgery

Trial details

NCT IDNCT05985551

SponsorUppsala University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-30

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.