Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer

NCT02481128 | Completed

• 1 other identifier: SenSzi (GBG80)
• Study Type: interventional
• Target: 1,198
• Locations: 2 countries
• Sites: 23

Brief Summary

Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized multicenter study design.

Conditions

Early-Stage Breast Carcinoma

Keywords

lymphoscintigraphy; sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (1)

• Average number of histologically detected sentinel lymph nodes per patient

  Number of resected sentinel lymph nodes is inversely correlated with false negative rate of sentinel lymph node biopsy. Average number of histologically detected sentinel lymph nodes per patient is assessed through pathologic report and serves as surrogate marker for false negative rate of sentinel node biopsy.

  Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

Secondary Outcomes (3)

• Rate of patients with proven metastasis in sentinel lymph nodes

  Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

• Rate of completion axillary dissection with proven metastasis in sentinel lymph nodes

  histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy

• Detection rates of sentinel nodes lymph nodes with preoperative lymphoscintigraphy vs. intraoperative gamma probe and histological detection rates of sentinel lymph nodes with vs. without preoperative access to lymphoscintigraphy

  Histological report expected within an average of 2 weeks after sentinel lymph node biopsy

Study Arms (2)

A (access to lymphoscintigraphy)

NO INTERVENTION

Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings

B (no access to lymphoscintigraphy)

EXPERIMENTAL

Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings

Procedure: without preoperative access to lymphoscintigraphy findings

Interventions

without preoperative access to lymphoscintigraphy findings PROCEDURE

axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

B (no access to lymphoscintigraphy)

Eligibility Criteria

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

You may qualify if:

• invasive mamma carcinoma as verified by core cut biopsy
• extensive ductal carcinoma in situ as verified by core cut biopsy (at least 5 cm or at least 2,5 cm and G3 grading)
• clinical stage tumor T1-T3
• no signs of axillary lymph node metastasis on clinical examination including ultrasound examination
• no signs of distant metastatic disease
• male/ female patient in the age not less than 18 years
• Karnofsky performance status at least 70% or Eastern Cooperative Oncology Group (ECOG) score not higher than 1
• written patient informed consent

You may not qualify if:

• suspect axillary lymph nodes on clinical/ultrasound examination
• positive fine-needle biopsy of axillary lymph nodes
• sentinel lymph node biopsy to be performed after neoadjuvant chemotherapy
• recurrence of a mamma carcinoma
• prior extensive surgery of breast or axilla
• inflammatory or extramammary breast cancer
• pregnancy
• contraindication to the radionuclide
• inability to understand the studies purpose
• inability to receive surgery
• no written patient informed consent

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• GBG Forschungs GmbH: collaborator

Study Sites (23)

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Location

Brustzentrum im Klinikum Ansbach

Ansbach, 91522, Germany

Location

Brustzentrum am Hochwaldkrankenhaus Bad Nauheim

Bad Nauheim, 61231, Germany

Location

Kreisklinik Ebersberg, Brustzentrum

Ebersberg, 85560, Germany

Location

Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen

Esslingen am Neckar, 73730, Germany

Location

Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum

Frankfurt A. M., 60431, Germany

Location

Franziskus Hospital Harderberg, Brustzentrum Osnabrück

Georgsmarienhütte, 49129, Germany

Location

Asklepios Harzkliniken Goslar, Brustzentrum

Goslar, 38642, Germany

Location

Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe

Gütersloh, 33332, Germany

Location

Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik

Gütersloh, 33332, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Kreiskrankenhaus Bergstrasse, Brustzentrum

Heppenheim an der Bergstrasse, 64646, Germany

Location

Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel

Kiel, 24105, Germany

Location

Universitätsfrauenklinik Magdeburg, Brustzentrum

Magdeburg, 39108, Germany

Location

Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein

Mönchengladbach, 41061, Germany

Location

Universitätsfrauenklinik am Klinikum Südstadt Rostock

Rostock, 18059, Germany

Location

DRK Krankenhaus Saarlouis, Brustzentrum

Saarlouis, 66740, Germany

Location

Leopoldina Krankenhaus Schweinfurt, Brustzentrum

Schweinfurt, 97422, Germany

Location

Klinikum St. Elisabeth Straubing, Brustzentrum

Straubing, 94304, Germany

Location

Katharinen Hospital Unna, Brustzentrum

Unna, 59423, Germany

Location

Kliniken Nordoberpfalz, Frauenklinik

Weiden, 92637, Germany

Location

Marien-Hospital Wesel, Brustzentrum

Wesel, 46483, Germany

Location

Brustzentrum Bern, Engerriedspital/Lindenhofspital

Bern, 3012, Switzerland

Location

Related Publications (2)

• Kuemmel S, Holtschmidt J, Gerber B, Von der Assen A, Heil J, Thill M, Krug D, Schem C, Denkert C, Lubitz J, Blohmer JU, Reinisch M, Hotzeldt M, Seither F, Nekljudova V, Schwidde I, Uhrhan K, Von Minckwitz G, Rezai M, Mulowski J, Loibl S, Kuehn T. Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial. J Clin Oncol. 2019 Jun 10;37(17):1490-1498. doi: 10.1200/JCO.18.02092. Epub 2019 May 1.

  PMID: 31042410 RESULT

• Holtschmidt J, Kuemmel S, Krug D, Breit E, Kuehn T, Reinisch M. Reply to E. Hindie and A.K. Goel et al. J Clin Oncol. 2019 Oct 10;37(29):2705-2707. doi: 10.1200/JCO.19.01860. Epub 2019 Aug 29. No abstract available.

  PMID: 31465263 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Sherko Kümmel, MD

  Kliniken Essen-Mitte

  PRINCIPAL INVESTIGATOR

• Thorsten Kühn, MD

  Klinikum Esslingen

  STUDY CHAIR

• Johannes Holtschmidt, MD

  Kliniken Essen-Mitte

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 25, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (22); CH (1)