NCT00636467|CompletedPhase 2
Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm
GAS2PLUS
Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm
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GAS2PLUS
Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm
Sponsor study identifier
Secondary identifiers
interventional
249
1 country
22
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection). Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month. The number of patients required in this multicentric and prospective study is 240 (16 participating centers).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2008
Actual (reported)March 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 14, 2008
Actual (reported)September 2011
Actual (reported)September 2011
Actual (reported)Quality criteria of the SLN detection technique
1 month
Total number of sampled SLN per patient
1 month
Detection of SLN by means of extra-axillary markings (lymphoscintigraphy)
1 month
Histopathological results (SLN)
1 month
Histopathological results (dissection)
1 month
Injection of Nanocis® or Nanocoll® (Tc-colloid) on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
Injection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Paul Papin
Angers, 49033, France
Institut Bergonié
Bordeaux, 33076, France
CH Boulogne sur Mer
Boulogne-sur-Mer, 62321, France
CH Calais
Calais, 62107, France
Clinique des 2 Caps
Coquelles, 62231, France
Clinique des Acacias
Cucq, 62780, France
Clinique Pasteur
Guilherand-Granges, 07500, France
Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. doi: 10.1056/NEJM199504063321401.
Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.
Hervé MIGNOTTE, MD
Centre Leon Berard, Lyon
249 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2008
First Posted
March 14, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer
Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
Contact the study team to confirm eligibility.
Centre Oscar Lambret
Lille, 59000, France
Hôtel Dieu
Lyon, 69002, France
Centre Léon Bérard
Lyon, 69008, France
Institut Paoli Calmettes
Marseille, 13009, France
Centre Val d'Aurelle
Montpellier, 34005, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CH Arrondissement Montreuil sur Mer
Rang-du-Fliers, 62180, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
Centre René Huguenin
Saint-Cloud, 92210, France
CHRU Saint Etienne
Saint-Etienne, 42055, France
Centre René Gauducheau
Saint-Herblain, 44805, France
CMCO
Saint-Martin-Boulogne, 62280, France
Institut Claudius Régaud
Toulouse, 31052, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Ververs JM, Roumen RM, Vingerhoets AJ, Vreugdenhil G, Coebergh JW, Crommelin MA, Luiten EJ, Repelaer van Driel OJ, Schijven M, Wissing JC, Voogd AC. Risk, severity and predictors of physical and psychological morbidity after axillary lymph node dissection for breast cancer. Eur J Cancer. 2001 May;37(8):991-9. doi: 10.1016/s0959-8049(01)00067-3.
Kissin MW, Querci della Rovere G, Easton D, Westbury G. Risk of lymphoedema following the treatment of breast cancer. Br J Surg. 1986 Jul;73(7):580-4. doi: 10.1002/bjs.1800730723.
Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015.
Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6.
Glass EC, Essner R, Giuliano AE. Sentinel node localization in breast cancer. Semin Nucl Med. 1999 Jan;29(1):57-68. doi: 10.1016/s0001-2998(99)80030-0.
Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast carcinoma. Ann Surg. 1997 Sep;226(3):271-6; discussion 276-8. doi: 10.1097/00000658-199709000-00006.
McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL, Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel lymph node biopsy for breast cancer: a suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol. 2000 Jul;18(13):2560-6. doi: 10.1200/JCO.2000.18.13.2560.
Weaver DL, Krag DN, Ashikaga T, Harlow SP, O'Connell M. Pathologic analysis of sentinel and nonsentinel lymph nodes in breast carcinoma: a multicenter study. Cancer. 2000 Mar 1;88(5):1099-107.
Tafra L, McMasters KM, Whitworth P, Edwards MJ. Credentialing issues with sentinel lymph node staging for breast cancer. Am J Surg. 2000 Oct;180(4):268-73. doi: 10.1016/s0002-9610(00)00466-9.
McMasters KM, Wong SL, Chao C, Woo C, Tuttle TM, Noyes RD, Carlson DJ, Laidley AL, McGlothin TQ, Ley PB, Brown CM, Glaser RL, Pennington RE, Turk PS, Simpson D, Edwards MJ; University of Louisville Breast Cancer Study Group. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: a model for implementation of new surgical techniques. Ann Surg. 2001 Sep;234(3):292-9; discussion 299-300. doi: 10.1097/00000658-200109000-00003.
Orr RK, Hoehn JL, Col NF. The learning curve for sentinel node biopsy in breast cancer: practical considerations. Arch Surg. 1999 Jul;134(7):764-7. doi: 10.1001/archsurg.134.7.764.
Bedrosian I, Reynolds C, Mick R, Callans LS, Grant CS, Donohue JH, Farley DR, Heller R, Conant E, Orel SG, Lawton T, Fraker DL, Czerniecki BJ. Accuracy of sentinel lymph node biopsy in patients with large primary breast tumors. Cancer. 2000 Jun 1;88(11):2540-5. doi: 10.1002/1097-0142(20000601)88:113.0.co;2-a.
Chung MH, Ye W, Giuliano AE. Role for sentinel lymph node dissection in the management of large (> or = 5 cm) invasive breast cancer. Ann Surg Oncol. 2001 Oct;8(9):688-92. doi: 10.1007/s10434-001-0688-y.
Lelievre L, Houvenaeghel G, Buttarelli M, Brenot-Rossi I, Huiart L, Tallet A, Tarpin C, Jacquemier J. Value of the sentinel lymph node procedure in patients with large size breast cancer. Ann Surg Oncol. 2007 Feb;14(2):621-6. doi: 10.1245/s10434-006-9232-4. Epub 2006 Nov 12.
Schwartz GF, Giuliano AE, Veronesi U; Consensus Conference Committee. Proceedings of the consensus conference on the role of sentinel lymph node biopsy in carcinoma of the breast, April 19-22, 2001, Philadelphia, Pennsylvania. Cancer. 2002 May 15;94(10):2542-51. doi: 10.1002/cncr.10539. No abstract available.
Lyman GH, Giuliano AE, Somerfield MR, Benson AB 3rd, Bodurka DC, Burstein HJ, Cochran AJ, Cody HS 3rd, Edge SB, Galper S, Hayman JA, Kim TY, Perkins CL, Podoloff DA, Sivasubramaniam VH, Turner RR, Wahl R, Weaver DL, Wolff AC, Winer EP; American Society of Clinical Oncology. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol. 2005 Oct 20;23(30):7703-20. doi: 10.1200/JCO.2005.08.001. Epub 2005 Sep 12.
Edwards M, Giuliano A, Reintgen D, Tafra L. Consensus statement on guidelines for performance of sentinel lymph node biopsy for breast cancer. Am Soc Breast Surg Q. Press Release, 1998 ;Fall :3
Primary Completion
September 2011
Actual (reported)Study Completion
September 2011
Actual (reported)Last Updated
September 26, 2012
Record last verified: 2012-09
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