Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer (SOLO-1)

SOLTI

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01669265

SOLTI-1113

Details and patient eligibility

About

This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.

The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.

Enrollment: 701 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed invasive breast carcinoma

• Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best clinical local practices

• Intraoperative evaluation of sentinel lymph node (SLN) by OSNA

• Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA

• Pathology report of the tumor and dissected lymph nodes that includes the following information:

  • primary tumor size (mm), tumor grade (Scarff-Bloom Richardson), estrogen receptor status
  • progesterone receptor status
  • HER2 status (ASCO/CAP guidelines)
  • Ki67 index
  • presence/absence of lymphovascular invasion
  • total number of sentinel and non-sentinel lymph nodes dissected during surgery
  • total number of positive and negative sentinel and non-sentinel lymph nodes, *size of the metastasis in both sentinel and non-sentinel lymph nodes
  • total tumoral load in each sentinel lymph node, expressed as number of CK19 mRNA copies per microliter.

Exclusion criteria

• Patients who underwent neoadjuvant chemotherapy
• CK19-negative breast tumor
• ALND with <10 lymph nodes
• In situ carcinoma only
• Metastatic breast cancer at time of diagnosis

Trial design

701 participants in 1 patient group

OSNA

Description:

Patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.