Study Summary
This trial is testing a new method for axillary staging in breast cancer patients with 1-2 positive sentinel nodes. The new method uses radioactive seed localization (RSL) to guide removal of the biopsy-proven node (TAD). The study will compare the technical success rate and accuracy of SNB+RSL to standard SNB.
Eligible Conditions
- Lymph Node Metastasis
- Breast Cancer
- Axillary Metastases
- Sentinel Lymph Node
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 1 month
1 month
False negative rate (FNR) of Radioactive Seed Localisation (RSL)
False negative rate (FNR) of Sentinel Node Biopsy (SNB)
False negative rate (FNR) of Targeted Axillary Dissection (TAD)
Identification rate of patients with three or more positive nodes using only radioactive seed localisation (RSL) vs. Targeted Axillary Dissection (TAD)
Reduction in recommended completion node dissection rate (CND) with the use of Targeted Axillary Dissection (TAD) vs. Sentinel Node Biopsy (SNB) alone.
Technical failure rate (TFR) of Radioactive Seed Localisation (RSL)
Technical failure rate (TFR) of Sentinel Node Biopsy (SNB)
Technical failure rate (TFR) of Targeted Axillary Dissection (TAD)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Targeted Axillary Dissection
1 of 1
Experimental Treatment
98 Total Participants · 1 Treatment Group
Primary Treatment: Targeted Axillary Dissection · No Placebo Group · N/A
Targeted Axillary DissectionExperimental Group · 2 Interventions: Targeted Axillary Dissection, Ultrasound of the axilla · Intervention Types: Procedure, DiagnosticTest
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Who is running the clinical trial?
Jewish General HospitalLead Sponsor
135 Previous Clinical Trials
319,550 Total Patients Enrolled
Quebec Breast Cancer FoundationOTHER
4 Previous Clinical Trials
698 Total Patients Enrolled
Erica Patocskai, MDStudy DirectorCentre hospitalier de l'Université de Montréal (CHUM)
2 Previous Clinical Trials
182 Total Patients Enrolled
Jean-François Boileau, MD,MSc,FRCSCStudy ChairJewish General Hospital
Léamarie Meloche-Dumas, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria
Age 18+ · Female Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Giuliano, Armando E., Karla V. Ballman, Linda McCall, Peter D. Beitsch, Meghan B. Brennan, Pond R. Kelemen, David W. Ollila, et al.. 2017. “Effect of Axillary Dissection Vs No Axillary Dissection on 10-year Overall Survival Among Women with Invasive Breast Cancer and Sentinel Node Metastasis”. Jama. American Medical Association (AMA). doi:10.1001/jama.2017.11470.
- Siegel, Rebecca L., Kimberly D. Miller, and Ahmedin Jemal. 2019. “Cancer Statistics, 2019”. CA: A Cancer Journal for Clinicians. Wiley. doi:10.3322/caac.21551.
- Giuliano, Armando E., Linda McCall, Peter Beitsch, Pat W. Whitworth, Peter Blumencranz, A. Marilyn Leitch, Sukamal Saha, Kelly K. Hunt, Monica Morrow, and Karla Ballman. 2010. “Locoregional Recurrence After Sentinel Lymph Node Dissection with or Without Axillary Dissection in Patients with Sentinel Lymph Node Metastases”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e3181f08f32.
- Mansel, Robert E., Lesley Fallowfield, Mark Kissin, Amit Goyal, Robert G. Newcombe, J. Michael Dixon, Constantinos Yiangou, et al.. 2006. “Randomized Multicenter Trial of Sentinel Node Biopsy Versus Standard Axillary Treatment in Operable Breast Cancer: The ALMANAC Trial”. JNCI: Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djj158.
- Krag, David N, Stewart J Anderson, Thomas B Julian, Ann M Brown, Seth P Harlow, Joseph P Costantino, Takamaru Ashikaga, et al.. 2010. “Sentinel-lymph-node Resection Compared with Conventional Axillary-lymph-node Dissection in Clinically Node-negative Patients with Breast Cancer: Overall Survival Findings from the NSABP B-32 Randomised Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(10)70207-2.
- Boileau, Jean-Francois, Brigitte Poirier, Mark Basik, Claire M.B. Holloway, Louis Gaboury, Lucas Sideris, Sarkis Meterissian, et al.. 2015. “Sentinel Node Biopsy After Neoadjuvant Chemotherapy in Biopsy-proven Node-positive Breast Cancer: The SN FNAC Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2014.55.7827.
- Classe, Jean-Marc, Cecile Loaec, P. Gimbergues, S. Alran, C. Tunon de Lara, P. F. Dupre, Roman Rouzier, et al.. 2018. “Sentinel Lymph Node Biopsy Without Axillary Lymphadenectomy After Neoadjuvant Chemotherapy Is Accurate and Safe for Selected Patients: The GANEA 2 Study”. Breast Cancer Research and Treatment. Springer Science and Business Media LLC. doi:10.1007/s10549-018-5004-7.
- Caudle, Abigail S., Wei T. Yang, Savitri Krishnamurthy, Elizabeth A. Mittendorf, Dalliah M. Black, Michael Z. Gilcrease, Isabelle Bedrosian, et al.. 2016. “Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients with Node-positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.64.0094.
- Boughey, Judy C.. 2013. “Sentinel Lymph Node Surgery After Neoadjuvant Chemotherapy in Patients with Node-positive Breast Cancer”. Jama. American Medical Association (AMA). doi:10.1001/jama.2013.278932.
- Kuehn, Thorsten, Ingo Bauerfeind, Tanja Fehm, Barbara Fleige, Maik Hausschild, Gisela Helms, Annette Lebeau, et al.. 2013. “Sentinel-lymph-node Biopsy in Patients with Breast Cancer Before and After Neoadjuvant Chemotherapy (SENTINA): A Prospective, Multicentre Cohort Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(13)70166-9.
- Caudle, Abigail S., Wei T. Yang, Elizabeth A. Mittendorf, Daliah M. Black, Rosa Hwang, Brian Hobbs, Kelly K. Hunt, Savitri Krishnamurthy, and Henry M. Kuerer. 2015. “Selective Surgical Localization of Axillary Lymph Nodes Containing Metastases in Patients with Breast Cancer”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2014.1086.
- Krag, David N, Stewart J Anderson, Thomas B Julian, Ann M Brown, Seth P Harlow, Joseph P Costantino, Takamaru Ashikaga, et al.. 2010. “Sentinel-lymph-node Resection Compared with Conventional Axillary-lymph-node Dissection in Clinically Node-negative Patients with Breast Cancer: Overall Survival Findings from the NSABP B-32 Randomised Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(10)70207-2.
- Boileau, Jean-Francois, Brigitte Poirier, Mark Basik, Claire M.B. Holloway, Louis Gaboury, Lucas Sideris, Sarkis Meterissian, et al.. 2015. “Sentinel Node Biopsy After Neoadjuvant Chemotherapy in Biopsy-proven Node-positive Breast Cancer: The SN FNAC Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2014.55.7827.
- Giuliano, Armando E., Karla V. Ballman, Linda McCall, Peter D. Beitsch, Meghan B. Brennan, Pond R. Kelemen, David W. Ollila, et al.. 2017. “Effect of Axillary Dissection Vs No Axillary Dissection on 10-year Overall Survival Among Women with Invasive Breast Cancer and Sentinel Node Metastasis”. Jama. American Medical Association (AMA). doi:10.1001/jama.2017.11470.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer, Version 1.2020. 2020.
- Mansel RE, Fallowfield L, Kissin M, Goyal A, Newcombe RG, Dixon JM, Yiangou C, Horgan K, Bundred N, Monypenny I, England D, Sibbering M, Abdullah TI, Barr L, Chetty U, Sinnett DH, Fleissig A, Clarke D, Ell PJ. Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst. 2006 May 3;98(9):599-609. doi: 10.1093/jnci/djj158. Erratum In: J Natl Cancer Inst. 2006 Jun 21;98(12):876.
- Jean-Francois Boileau 2021. "Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04671511.
Frequently Asked Questions
How many individuals are participating in the trial overall?
"Correct. Per the information available on clinicaltrials.gov, recruitment is in progress for this trial which was first posted on March 30th 2021 and last amended May 19th 2021. The goal is to bring 98 patients into the study at 2 sites." - Anonymous Online Contributor
Unverified Answer
Are there any current openings to join this research project?
"According to the clinicaltrials.gov database, this medical research project is currently seeking participants. It was first announced on March 30th 2021 and has undergone a recent revision of May 19th this year." - Anonymous Online Contributor
Unverified Answer