Clinical trial NCT01669265: Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
Official title: Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
OSNA
sentinel lymph node
Lead sponsor: SOLTI Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Sysmex America, Inc.
First posted: 2012-08-20
Enrollment: 701
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cT1-3, N0 breast cancer, who had intraoperative SLN evaluation by OSNA assay with a complete axillary lymph node dissection.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Estimate the negative predictive value of the technique OSNA.
timeFrame: At time of surgery
Secondary outcomes:
measure: ROC curve that describes the assay
timeFrame: At time of surgery
measure: Sensitivity of the assay
timeFrame: At time of surgery
measure: Specificity of the assay
timeFrame: At time of surgery
measure: Likelihood ratio for the cutoff of 10,000-15,000 copies/uL
timeFrame: At time of surgery
measure: Positive predictive value at the cutoff of 10.000-15.000 copies/μL.
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Vall d´Hebron University Hospital
city: La Coruña
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Seville
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
Study officials:
affiliation: Vall d´Hebron University Hospital
name: Vicente Peg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vall d´Hebron University Hospital
name: Isabel Rubio, MD, PhD
role: STUDY_CHAIR
affiliation: Vall d´Hebron University Hospital
name: Martin Espinosa-Bravo, MD, PhD
role: STUDY_CHAIR
References:
citation: Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez JR, de Salas MS, Delgado-Sanchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Tellez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 May;139(1):87-93. doi: 10.1007/s10549-013-2524-z. Epub 2013 Apr 11.
citation: 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 cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.