Sentinel Node Biopsy Before and/or After Neoadjuvant Chemotherapy in Breast Cancer

NCT02031042 | Completed

• 1 other identifier: 2010/441-31/4
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this study is to investigate if sentinel lymph node biopsy is a reliable staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the sentinel lymph node is free of metastasis.

Conditions

Breast Cancer

Keywords

neoadjuvant chemotherapy; breast cancer; sentinel lymph node biopsy; false negative rate; identification rate

Outcome Measures

Primary Outcomes (1)

• False negative rate

  The rate of patients with no metastasis/ses in their sentinel lymph node/s before neoadjuvant chemotherapy (NAC) but metastasis/ses in the nodes from the axillary lymph node dissection performed after NAC will be analysed. In substudy II we also investigate the false negative rate in sentinel lymph node biopsies performed after NAC if the patient had positive lymph nodes at diagnosis.

  Up to two years

Secondary Outcomes (1)

• Identification rate

  Up to two years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically verified breast cancer planned for neoadjuvant chemotherapy

You may qualify if:

• clinically node-negative (or unclear nodal status) substudy I
• signed consent from the study participant

You may not qualify if:

• inflammatory breast cancer
• 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

Sponsors & Collaborators

• Stockholm South General Hospital: lead
• Swedish Breast Cancer Group: collaborator

Study Sites (20)

Falu lasarett

Falun, 791 85, Sweden

Location

Sahlgrenska Universitetssjukhuset, Sahlgrenska

Gothenburg, 413 45, Sweden

Location

Länssjukhuset i Halmstad

Halmstad, 301 85, Sweden

Location

Helsingborgs lasarett

Helsingborg, 251 87, Sweden

Location

Blekingesjukhuset Karlskrona

Karlskrona, 371 81, Sweden

Location

Centralsjukhuset i Karlstad

Karlstad, 651 85, Sweden

Location

Centralsjukhuset i Kristianstad

Kristianstad, 291 85, Sweden

Location

Universitetssjukhuset i Linköping

Linköping, 581 85, Sweden

Location

Skånes Universitetssjukhus, Lund

Lund, 221 85, Sweden

Location

Skånes Universitetssjukhus, Malmö

Malmo, 205 02, Sweden

Location

Universitetssjukhuset i Örebro

Örebro, 701 85, Sweden

Location

Capio St Görans Sjukhus

Stockholm, 112 81, Sweden

Location

Södersjukhuset/Stockholm South General Hospital

Stockholm, 118 83, Sweden

Location

Karolinska Universitetssjukhuset i Solna

Stockholm, 171 76, Sweden

Location

Länssjukhuset Sundsvall-Härnösand

Sundsvall, 851 86, Sweden

Location

NU-sjukvården, Uddevalla sjukhus

Uddevalla, 451 80, Sweden

Location

Norrlands Universitetssjukhus

Umeå, 901 85, Sweden

Location

Akademiska sjukhuset i Uppsala

Uppsala, 751 85, Sweden

Location

Centrallasaretttet i Växjö

Vaxjo, 351 85, Sweden

Location

Centrallasarettet i Västerås

Västerås, 721 89, Sweden

Location

Related Publications (9)

• 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.

  PMID: 10400039 BACKGROUND

• 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.

  PMID: 14559892 BACKGROUND

• 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.

  PMID: 15837984 BACKGROUND

• 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.

  PMID: 16329089 BACKGROUND

• 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.

  PMID: 12846861 BACKGROUND

• 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.

  PMID: 18683193 BACKGROUND

• 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.

  PMID: 23683750 BACKGROUND

• 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.

  PMID: 24101169 BACKGROUND

• 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.

  PMID: 28213781 DERIVED

Related Links

• Homepage for the Swedish Breast Surgical Association

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Linda H Zetterlund, PhD

  Dep. of Medical Research and Education, Karolinska Institutet (KI), Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

• Fuat Celebioglu, PhD

  Dep. of Medical Research and Education, KI, Stockholm, Sweden

  STUDY CHAIR

• Jan Frisell, Professor

  Dep. of Molecular Medicine and Surgery, KI, Stockholm, Sweden

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 9, 2014
• Study Start: October 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (20)