Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment

NCT05985551 | Active Not Recruiting DMC

• 1 other identifier: UUBreast03
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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 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. 1.If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection
2. 2.If the nodal yield and the accuracy of the procedure are affected

Conditions

Breast Cancer; Chemotherapy Effect; Sentinel Lymph Node

Keywords

Neoadjuvant therapy; Breast Cancer; Superparamagnetic Iron oxide nanoparticles; SLND; Targeted axillary Dissection; Delayed SLND

Outcome Measures

Primary Outcomes (3)

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

  This endpoint is necessary in ensuring that prolonged SPIO administration does not result in the retrieval of "false" SLNs, in the case that SPIO migrates to higher nodal echelons. As the radioisotope is the current standard of care, the concordance of SPIO to the radioisotope and its correlation with time of SPIO adminstration is the appropriate surrogate endpoint.

  At surgery

• Detection rate

  The successful retrieval of at least one SLN detected by each tracer (SPIO or radioisotope) separately.

  At surgery

• Concordance

  The rate (patients with at least one SLN detected with both tracers/patients with at least one SLN detected with the radioisotope)

  At surgery

Secondary Outcomes (2)

• Nodal yield

  At surgery

• Nodal concordance

  At surgery

Other Outcomes (2)

• Detection rate for 2 and 3 SLNs

  At surgery

• Adverse events

  From time of SPIO administration to four weeks after surgery

Interventions

SLND or TAD by the magnetic technique (SPIO) OTHER

All patients will receive Radioisotope according to standard of care. They will also receive SPIO in a timeframe of clinical convenience, depending on whether primary response is planned by means of MRI. For patients that are ycN0, SLND or TAD will be performed. For those that convert from cN1 to ycN0, the index lymph node will be marked with a paramagnetic marker. Axillary surgery will be undertaken with the magnetic technique and each retrieved lymph node will be controlled for radiation. Upon the completion of the procedure, a background control will be performed with the radioactive signal as guide, to ensure standard of care best practice. Any palpable lymph nodes that are not sentinels with either tracer may be removed at surgeon discretion but will be reported seperately.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that fulfilled all eligibility criteria as listed above

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ferric oxide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andreas U Karakatsanis, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2020
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)