Sentinel Node Biopsy Before and/or After Neoadjuvant Chemotherapy in Breast Cancer
NCT ID: NCT02031042
Last Updated: 2019-10-28
Study Results
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Basic Information
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COMPLETED
224 participants
OBSERVATIONAL
2010-10-31
2015-12-31
Brief Summary
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Detailed Description
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Neoadjuvant chemotherapy (NAC) given before breast surgery is indicated for locally advanced breast cancer but is increasingly used for early stage breast cancer with the purpose of downstaging the tumor and thereby possibly enabling breast conserving surgery. Traditionally, the standard axillary staging tool has been ALND although up to 50 per cent of the patients at diagnosis do not have any metastases in their axillary lymph nodes. In addition, NAC can eradicate metastases in the axillary lymph nodes in up to 40 per cent of the patients.
SLNB has therefore been evaluated in the neoadjuvant setting both before and after NAC but is still controversial and the timing debated.
This is a Swedish prospective multi-institutional study without any comparison goup. The comparison is between the findings in the SLNB and the following ALND performed after NAC in all patients.
If the patient is clinically node-negative at diagnosis a SLNB is performed before (without frozen section) and after NAC (substudy I). The reasons for repeating SLNB both before and after NAC are 1) to find out what happens during NAC 2) if it is possible to identify a repeat SLNB and 3) if it is reliable.
If the patient is node-positive at diagnosis (cytologically verified lymph node metastasis) SLNB is performed after NAC together with the breast operation and ALND (substudy II). When SLNB is performed after NAC, the sentinel lymph nodes are also analysed with frozen section in order to validate the method after chemotherapy. Both blue dye and radiolabelled isotope for localisation of the sentinel lymph node is recommended but lymphoscintigraphy is optional.
All consecutive clinically node-negative (or with unclear nodal status after ultrasound and cytology) patients planned for NAC will have oral and written information about the study by the responsible surgeon. After accepting to participate, the patient is asked to sign a written consent. Patients with a cytologically verified lymph node metastasis/es at diagnosis will be informed and asked to participate in substudy II after completion of NAC.
According to the statistical analysis, and with an expected loss of 10 per cent, a sample size of 220 patients is needed in substudy I to show that the false negative rate is less than 10 per cent. If we include 200 patients and 50 per cent are lymph node positive at diagnosis then the estimation of false negative rate will be based on 100 individuals. If we estimate the true false negative rate to be 8 per cent, then the precision with 80 per cent power will be +/- 7 per cent units (2-sided test with 95 per cent confidence interval).
The Central Contact (PI) is responsible for data collection, management and analysis. Each protocol will be sent together with a written consent and copies of all relevant histopathological reports to the PI, who will control for missing or incongruent data and if so, ask the responsible investigator on that institution/hospital to complement the missing data from the patients journal (copies of medical records or histopathological reports).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* signed consent from the study participant
Exclusion Criteria
* cytologically verified lymph node metastasis/es at diagnosis (substudy I), but these patients can be included in substudy II
* patients not able to give an informed consent
* hypersensitivity or allergy against blue dye or isotope
18 Years
ALL
No
Sponsors
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Swedish Breast Cancer Group
OTHER
Stockholm South General Hospital
OTHER
Responsible Party
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Linda Zetterlund
MD, PhD student
Principal Investigators
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Linda H Zetterlund, PhD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Medical Research and Education, Karolinska Institutet (KI), Stockholm, Sweden
Fuat Celebioglu, PhD
Role: STUDY_CHAIR
Dep. of Medical Research and Education, KI, Stockholm, Sweden
Jan Frisell, Professor
Role: STUDY_CHAIR
Dep. of Molecular Medicine and Surgery, KI, Stockholm, Sweden
Locations
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Falu lasarett
Falun, , Sweden
Sahlgrenska Universitetssjukhuset, Sahlgrenska
Gothenburg, , Sweden
Länssjukhuset i Halmstad
Halmstad, , Sweden
Helsingborgs lasarett
Helsingborg, , Sweden
Blekingesjukhuset Karlskrona
Karlskrona, , Sweden
Centralsjukhuset i Karlstad
Karlstad, , Sweden
Centralsjukhuset i Kristianstad
Kristianstad, , Sweden
Universitetssjukhuset i Linköping
Linköping, , Sweden
Skånes Universitetssjukhus, Lund
Lund, , Sweden
Skånes Universitetssjukhus, Malmö
Malmo, , Sweden
Universitetssjukhuset i Örebro
Örebro, , Sweden
Capio St Görans Sjukhus
Stockholm, , Sweden
Södersjukhuset/Stockholm South General Hospital
Stockholm, , Sweden
Karolinska Universitetssjukhuset i Solna
Stockholm, , Sweden
Länssjukhuset Sundsvall-Härnösand
Sundsvall, , Sweden
NU-sjukvården, Uddevalla sjukhus
Uddevalla, , Sweden
Norrlands Universitetssjukhus
Umeå, , Sweden
Akademiska sjukhuset i Uppsala
Uppsala, , Sweden
Centrallasaretttet i Växjö
Vaxjo, , Sweden
Centrallasarettet i Västerås
Västerås, , Sweden
Countries
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References
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Kuerer HM, Sahin AA, Hunt KK, Newman LA, Breslin TM, Ames FC, Ross MI, Buzdar AU, Hortobagyi GN, Singletary SE. Incidence and impact of documented eradication of breast cancer axillary lymph node metastases before surgery in patients treated with neoadjuvant chemotherapy. Ann Surg. 1999 Jul;230(1):72-8. doi: 10.1097/00000658-199907000-00011.
Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
Xing Y, Foy M, Cox DD, Kuerer HM, Hunt KK, Cormier JN. Meta-analysis of sentinel lymph node biopsy after preoperative chemotherapy in patients with breast cancer. Br J Surg. 2006 May;93(5):539-46. doi: 10.1002/bjs.5209.
Schrenk P, Hochreiner G, Fridrik M, Wayand W. Sentinel node biopsy performed before preoperative chemotherapy for axillary lymph node staging in breast cancer. Breast J. 2003 Jul-Aug;9(4):282-7. doi: 10.1046/j.1524-4741.2003.09406.x.
Papa MZ, Zippel D, Kaufman B, Shimon-Paluch S, Yosepovich A, Oberman B, Sadetzki S. Timing of sentinel lymph node biopsy in patients receiving neoadjuvant chemotherapy for breast cancer. J Surg Oncol. 2008 Nov 1;98(6):403-6. doi: 10.1002/jso.21128.
Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.
Zetterlund L, Celebioglu F, Axelsson R, de Boniface J, Frisell J. Swedish prospective multicenter trial on the accuracy and clinical relevance of sentinel lymph node biopsy before neoadjuvant systemic therapy in breast cancer. Breast Cancer Res Treat. 2017 May;163(1):93-101. doi: 10.1007/s10549-017-4163-2. Epub 2017 Feb 17.
Related Links
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Homepage for the Swedish Breast Surgical Association
Other Identifiers
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2010/441-31/4
Identifier Type: -
Identifier Source: org_study_id
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