Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer
Primary Purpose
Early-Stage Breast Carcinoma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
without preoperative access to lymphoscintigraphy findings
Sponsored by
About this trial
This is an interventional diagnostic trial for Early-Stage Breast Carcinoma focused on measuring lymphoscintigraphy, sentinel lymph node biopsy
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
Sites / Locations
- Kliniken Essen-Mitte
- Brustzentrum im Klinikum Ansbach
- Brustzentrum am Hochwaldkrankenhaus Bad Nauheim
- Kreisklinik Ebersberg, Brustzentrum
- Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen
- Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum
- Franziskus Hospital Harderberg, Brustzentrum Osnabrück
- Asklepios Harzkliniken Goslar, Brustzentrum
- Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe
- Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik
- Universitätsklinikum Hamburg Eppendorf
- Kreiskrankenhaus Bergstrasse, Brustzentrum
- Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel
- Universitätsfrauenklinik Magdeburg, Brustzentrum
- Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein
- Universitätsfrauenklinik am Klinikum Südstadt Rostock
- DRK Krankenhaus Saarlouis, Brustzentrum
- Leopoldina Krankenhaus Schweinfurt, Brustzentrum
- Klinikum St. Elisabeth Straubing, Brustzentrum
- Katharinen Hospital Unna, Brustzentrum
- Kliniken Nordoberpfalz, Frauenklinik
- Marien-Hospital Wesel, Brustzentrum
- Brustzentrum Bern, Engerriedspital/Lindenhofspital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
A (access to lymphoscintigraphy)
B (no access to lymphoscintigraphy)
Arm Description
Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings
Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of patients with proven metastasis in sentinel lymph nodes
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.
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
Full Information
NCT ID
NCT02481128
First Posted
June 5, 2015
Last Updated
July 8, 2020
Sponsor
Kliniken Essen-Mitte
Collaborators
German Breast Group
1. Study Identification
Unique Protocol Identification Number
NCT02481128
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kliniken Essen-Mitte
Collaborators
German Breast Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Stage Breast Carcinoma
Keywords
lymphoscintigraphy, sentinel lymph node biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A (access to lymphoscintigraphy)
Arm Type
No Intervention
Arm Description
Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings
Arm Title
B (no access to lymphoscintigraphy)
Arm Type
Experimental
Arm Description
Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings
Intervention Type
Procedure
Intervention Name(s)
without preoperative access to lymphoscintigraphy findings
Intervention Description
axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings
Primary Outcome Measure Information:
Title
Average number of histologically detected sentinel lymph nodes per patient
Description
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.
Time Frame
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Secondary Outcome Measure Information:
Title
Rate of patients with proven metastasis in sentinel lymph nodes
Time Frame
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Title
Rate of completion axillary dissection with proven metastasis in sentinel lymph nodes
Description
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.
Time Frame
histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy
Title
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
Time Frame
Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherko Kümmel, MD
Organizational Affiliation
Kliniken Essen-Mitte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thorsten Kühn, MD
Organizational Affiliation
Klinikum Esslingen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johannes Holtschmidt, MD
Organizational Affiliation
Kliniken Essen-Mitte
Official's Role
Study Chair
Facility Information:
Facility Name
Kliniken Essen-Mitte
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Brustzentrum im Klinikum Ansbach
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
Facility Name
Brustzentrum am Hochwaldkrankenhaus Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Kreisklinik Ebersberg, Brustzentrum
City
Ebersberg
ZIP/Postal Code
85560
Country
Germany
Facility Name
Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum
City
Frankfurt a. M.
ZIP/Postal Code
60431
Country
Germany
Facility Name
Franziskus Hospital Harderberg, Brustzentrum Osnabrück
City
Georgsmarienhütte
ZIP/Postal Code
49129
Country
Germany
Facility Name
Asklepios Harzkliniken Goslar, Brustzentrum
City
Goslar
ZIP/Postal Code
38642
Country
Germany
Facility Name
Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
Facility Name
Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Kreiskrankenhaus Bergstrasse, Brustzentrum
City
Heppenheim
ZIP/Postal Code
64646
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsfrauenklinik Magdeburg, Brustzentrum
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Universitätsfrauenklinik am Klinikum Südstadt Rostock
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
DRK Krankenhaus Saarlouis, Brustzentrum
City
Saarlouis
ZIP/Postal Code
66740
Country
Germany
Facility Name
Leopoldina Krankenhaus Schweinfurt, Brustzentrum
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Facility Name
Klinikum St. Elisabeth Straubing, Brustzentrum
City
Straubing
ZIP/Postal Code
94304
Country
Germany
Facility Name
Katharinen Hospital Unna, Brustzentrum
City
Unna
ZIP/Postal Code
59423
Country
Germany
Facility Name
Kliniken Nordoberpfalz, Frauenklinik
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Marien-Hospital Wesel, Brustzentrum
City
Wesel
ZIP/Postal Code
46483
Country
Germany
Facility Name
Brustzentrum Bern, Engerriedspital/Lindenhofspital
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31042410
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.
Results Reference
result
PubMed Identifier
31465263
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.
Results Reference
result
Learn more about this trial
Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer
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