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

NCT ID: NCT02481128

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-01-31

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.

Detailed Description

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. Several studies indicate sentinel node biopsy to be a reliable method irrespective of prior lymph node scintigraphy, but data from prospective randomized trials are not available.

Although a preoperative lymph node scintigraphy is not explicitly demanded in current S3 guidelines in Germany its performance is a common practice.

If a preoperative lymphoscintigraphy could be safely omitted, possible benefits are a facilitation of the preoperative workflow as well as cost reduction for health care systems.

This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized study design. In the two study arms sentinel node biopsy is performed either with or without knowledge of the preoperative lymphoscintigraphy findings. Primary end point is the average number of histologically detected sentinel lymph nodes per patient in both treatment arms.

Conditions

Early-Stage Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A (access to lymphoscintigraphy)

Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings

Group Type: NO_INTERVENTION

No interventions assigned to this group

B (no access to lymphoscintigraphy)

Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings

Group Type: EXPERIMENTAL

without preoperative access to lymphoscintigraphy findings

Intervention Type: PROCEDURE

axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

Interventions

without preoperative access to lymphoscintigraphy findings

axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GBG Forschungs GmbH

OTHER

Sponsor Role: collaborator

Kliniken Essen-Mitte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherko Kümmel, MD

Role: PRINCIPAL_INVESTIGATOR

Kliniken Essen-Mitte

Thorsten Kühn, MD

Role: STUDY_CHAIR

Klinikum Esslingen

Johannes Holtschmidt, MD

Role: STUDY_CHAIR

Kliniken Essen-Mitte

Locations

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Brustzentrum im Klinikum Ansbach

Ansbach, , Germany

Brustzentrum am Hochwaldkrankenhaus Bad Nauheim

Bad Nauheim, , Germany

Kreisklinik Ebersberg, Brustzentrum

Ebersberg, , Germany

Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen

Esslingen am Neckar, , Germany

Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum

Frankfurt A. M., , Germany

Franziskus Hospital Harderberg, Brustzentrum Osnabrück

Georgsmarienhütte, , Germany

Asklepios Harzkliniken Goslar, Brustzentrum

Goslar, , Germany

Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe

Gütersloh, , Germany

Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik

Gütersloh, , Germany

Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Kreiskrankenhaus Bergstrasse, Brustzentrum

Heppenheim an der Bergstrasse, , Germany

Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel

Kiel, , Germany

Universitätsfrauenklinik Magdeburg, Brustzentrum

Magdeburg, , Germany

Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein

Mönchengladbach, , Germany

Universitätsfrauenklinik am Klinikum Südstadt Rostock

Rostock, , Germany

DRK Krankenhaus Saarlouis, Brustzentrum

Saarlouis, , Germany

Leopoldina Krankenhaus Schweinfurt, Brustzentrum

Schweinfurt, , Germany

Klinikum St. Elisabeth Straubing, Brustzentrum

Straubing, , Germany

Katharinen Hospital Unna, Brustzentrum

Unna, , Germany

Kliniken Nordoberpfalz, Frauenklinik

Weiden, , Germany

Marien-Hospital Wesel, Brustzentrum

Wesel, , Germany

Brustzentrum Bern, Engerriedspital/Lindenhofspital

Bern, , Switzerland

Countries

Germany; Switzerland

References

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.

Reference Type: RESULT

PMID: 31042410 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31465263 (View on PubMed)

Other Identifiers

SenSzi (GBG80)

Identifier Type: -

Identifier Source: org_study_id