Status:
ACTIVE_NOT_RECRUITING
Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Uppsala University Hospital
Conditions:
Breast Cancer
Chemotherapy Effect
Eligibility:
All Genders
18+ years
Brief 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 wh...
Detailed Description
Superparamagnetic Iron Nanoparticles (SPIO) have shown comparable performance to the standard of Radioisotope (RI) +/- blue dye (BD) for Sentinel Lymph Node Detection in breast cancer, with the advant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05985551
Start Date
January 1 2020
End Date
October 30 2027
Last Update
May 3 2024
Active Locations (1)
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1
Uppsala University Hospital
Uppsala, Sweden, 75185