Sentinel Node After Neoadjuvancy In Node-Positive Breast Cancer
SANA
1 other identifier
interventional
90
1 country
1
Brief Summary
The status of the axillary lymph nodes is one of the main prognostic factors in breast cancer (BC). SLNB is currently the standard staging method for patients with clinically node-negative (cN0) breast cancer. In patients with a positive SLN and in those with affected lymph nodes at the beginning (cN+), LND is the standard of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jun 2016
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedApril 29, 2021
April 1, 2021
4.3 years
April 12, 2021
April 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Targetted axilary dissection detection rate in cN+ after neoadjuvant therapy
Targetted axilary dissection detection rate in cN+ after neoadjuvant therapy (Sentinel lymph node plus cliped node)
immediately after surgery
Secondary Outcomes (7)
False negative Rate
immediately after surgery
Concordance
immediately after surgery
Ultrasound before-after NAC
before the start of systemic therapy - after finishing systemic therapy just before surgery
Response Rate by biological profile
immediately after the intervention/procedure/surgery
Response Rate by treatment
immediately after the intervention/procedure/surgery
- +2 more secondary outcomes
Study Arms (1)
TAD arm
EXPERIMENTALSentinel Node Biopsy + Targetted Axillary Dissection (Clipped cN1 node) extraction + lymphadenectomy.
Interventions
Sentinel Node Biopsy + Targetted Axillary Dissection (Previously to surgery marked cN1 node) + Lymphadenectomy
Eligibility Criteria
You may qualify if:
- Age equal to or greater than 18 years
- Patients with a diagnosis of T1-T3 primary infiltrating breast carcinoma
- Axillary clinical involvement (cN +)
- Confirmation by FNAC or BAG of lymph node involvement
- Candidates for neoadjuvant chemotherapy including anthracyclines and taxanes
You may not qualify if:
- T4 tumors
- Supra / infraclavicular lymph node or internal mammary chain (cN3) involvement
- Previous ipsilateral breast or axillary surgery
- Distant metastasis at diagnosis (M1)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Immaculada Alonso Vargas, MD PhD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 29, 2021
Study Start
June 1, 2016
Primary Completion
September 1, 2020
Study Completion
January 1, 2021
Last Updated
April 29, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share