Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01669265
• Lead Sponsor: SOLTI Breast Cancer Research Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-24
• Study Start: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 701

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate the negative predictive value of the technique OSNA.	At time of surgery	Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.

Secondary Outcome Measures

Name	Time	Method
ROC curve that describes the assay	At time of surgery	ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs
Sensitivity of the assay	At time of surgery	Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)
Specificity of the assay	At time of surgery	Probability that OSNA in SLN is negative because there is no involvement of NSLN
Likelihood ratio for the cutoff of 10,000-15,000 copies/uL	At time of surgery	Likelihood ratio of positive and negative results
Positive predictive value at the cutoff of 10.000-15.000 copies/μL.	At time of surgery

Trial Locations

Locations (9)

Hospital Universitario de Bellvitge; 🇪🇸 Barcelona, Spain

Vall d´Hebron University Hospital; 🇪🇸 Barcelona, Spain

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 La Coruña, Spain

Hospital Universitario de Gran Canaria Doctor Negrin; 🇪🇸 Las Palmas, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Arnau de Vilanova; 🇪🇸 Lleida, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Virgen Del Rocio; 🇪🇸 Seville, Spain