Clinical trial NCT02481128: Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early-Stage Breast Carcinoma
Keywords: lymphoscintigraphy
sentinel lymph node biopsy
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
Collaborators: name: GBG Forschungs GmbH
First posted: 2015-06-25
Enrollment: 1198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Average number of histologically detected sentinel lymph nodes per patient
timeFrame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Secondary outcomes:
measure: Rate of patients with proven metastasis in sentinel lymph nodes
timeFrame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
measure: Rate of completion axillary dissection with proven metastasis in sentinel lymph nodes
timeFrame: histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy
measure: 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
timeFrame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: Nordrhein-Westfalen
city: Ansbach
country: Germany
facility: Brustzentrum im Klinikum Ansbach
city: Bad Nauheim
country: Germany
facility: Brustzentrum am Hochwaldkrankenhaus Bad Nauheim
city: Ebersberg
country: Germany
facility: Kreisklinik Ebersberg, Brustzentrum
city: Esslingen
country: Germany
facility: Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen
city: Frankfurt a. M.
country: Germany
facility: Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum
city: Georgsmarienhütte
country: Germany
facility: Franziskus Hospital Harderberg, Brustzentrum Osnabrück
city: Goslar
country: Germany
facility: Asklepios Harzkliniken Goslar, Brustzentrum
city: Gütersloh
country: Germany
facility: Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe
city: Gütersloh
country: Germany
facility: Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Heppenheim
country: Germany
facility: Kreiskrankenhaus Bergstrasse, Brustzentrum
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel
city: Magdeburg
country: Germany
facility: Universitätsfrauenklinik Magdeburg, Brustzentrum
city: Mönchengladbach
country: Germany
facility: Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein
city: Rostock
country: Germany
facility: Universitätsfrauenklinik am Klinikum Südstadt Rostock
city: Saarlouis
country: Germany
facility: DRK Krankenhaus Saarlouis, Brustzentrum
city: Schweinfurt
country: Germany
facility: Leopoldina Krankenhaus Schweinfurt, Brustzentrum
city: Straubing
country: Germany
facility: Klinikum St. Elisabeth Straubing, Brustzentrum
city: Unna
country: Germany
facility: Katharinen Hospital Unna, Brustzentrum
city: Weiden
country: Germany
facility: Kliniken Nordoberpfalz, Frauenklinik
city: Wesel
country: Germany
facility: Marien-Hospital Wesel, Brustzentrum
city: Bern
country: Switzerland
facility: Brustzentrum Bern, Engerriedspital/Lindenhofspital
Study officials:
affiliation: Kliniken Essen-Mitte
name: Sherko Kümmel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Esslingen
name: Thorsten Kühn, MD
role: STUDY_CHAIR
affiliation: Kliniken Essen-Mitte
name: Johannes Holtschmidt, MD
role: STUDY_CHAIR
References:
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, 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.
citation: 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.