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

Breast Cancer Clinical Trial

— SOLO-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669265
• Other study ID #: SOLTI-1113
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: November 17, 2014
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: November 2014
• Source: SOLTI Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 701
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Spain	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 Arnau de Vilanova	Lleida
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Virgen Del Rocio	Seville
Spain	Instituto Valenciano de Oncología	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
SOLTI Breast Cancer Research Group	Sysmex America, Inc.

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JJ, Salas MS, Sansano I, Delgado Sánchez JJ, Pinto W, Gozalbo F, Petit A, Rubio I. Intraoperative molecular analysis of sentinel lymph node as a new predictor of axillary status in early breast canc

Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JR, de Salas MS, Delgado-Sánchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Téllez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor — View Citation

Outcome

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

External Links

•   SOLTI Breast Cancer Research Group