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

Early-Stage Breast Carcinoma Clinical Trial

Official title:

Randomized Controlled Multicenter Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer; SenSzi (GBG80)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481128
• Other study ID #: SenSzi (GBG80)
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2020
• Source: Kliniken Essen-Mitte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1198
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-Stage Breast Carcinoma

Intervention

Procedure:
• without preoperative access to lymphoscintigraphy findings
axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

Locations

Country	Name	City	State
Germany	Brustzentrum im Klinikum Ansbach	Ansbach
Germany	Brustzentrum am Hochwaldkrankenhaus Bad Nauheim	Bad Nauheim
Germany	Kreisklinik Ebersberg, Brustzentrum	Ebersberg
Germany	Kliniken Essen-Mitte	Essen	Nordrhein-Westfalen
Germany	Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen	Esslingen
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
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
Switzerland	Brustzentrum Bern, Engerriedspital/Lindenhofspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Kliniken Essen-Mitte	German Breast Group

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (2)

Holtschmidt J, Kuemmel S, Krug D, Breit E, Kuehn T, Reinisch M. Reply to E. Hindié 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. — View Citation

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, Hötzeldt M, Seither F, Nekljudova V, Schwidde I, Uhrhan K, Von Minckwitz G, Rezai M, Mulowski J, Loibl S, Kuehn T. Prospect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of patients with proven metastasis in sentinel lymph nodes		Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Secondary	Rate of completion axillary dissection with proven metastasis in sentinel lymph nodes	A completion axillary dissection can be performed in case of proven metastasis in sentinel lymph nodes. A completion axillary dissection ca be performed either right away during sentinel lymph node biopsy or after completion of neoadjuvant chemotherapy. Hence assessment will be performed within 6 months after initial sentinel lymph node biopsy in order to include all patients planned for neoadjuvant chemotherapy.	histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy
Secondary	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