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Early-Stage Breast CarcinomaNCT02481128

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

A study testing without preoperative access to lymphoscintigraphy findings in people with Early-Stage Breast Carcinoma, run by Kliniken Essen-Mitte at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early-Stage Breast Carcinoma
What is being tested?
without preoperative access to lymphoscintigraphy findings
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,198 participants
Where
23 sitesin 2 countries
Study dates
May 2014to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • pregnancy
  • contraindication to the radionuclide
  • inability to understand the studies purpose
  • inability to receive surgery
  • no written patient informed consent

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

Germany22 sites

  • Brustzentrum im Klinikum Ansbach

    Ansbach, 91522

  • Brustzentrum am Hochwaldkrankenhaus Bad Nauheim

    Bad Nauheim, 61231

  • Kreisklinik Ebersberg, Brustzentrum

    Ebersberg, 85560

  • Kliniken Essen-Mitte

    Essen, North Rhine-Westphalia, 45136

  • Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum

    Frankfurt A. M., 60431

  • Franziskus Hospital Harderberg, Brustzentrum Osnabrück

    Georgsmarienhütte, 49129

  • Asklepios Harzkliniken Goslar, Brustzentrum

    Goslar, 38642

  • Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe

    Gütersloh, 33332

  • Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik

    Gütersloh, 33332

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Kreiskrankenhaus Bergstrasse, Brustzentrum

    Heppenheim an der Bergstrasse, 64646

  • Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel

    Kiel, 24105

  • Universitätsfrauenklinik Magdeburg, Brustzentrum

    Magdeburg, 39108

  • Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein

    Mönchengladbach, 41061

  • Universitätsfrauenklinik am Klinikum Südstadt Rostock

    Rostock, 18059

  • DRK Krankenhaus Saarlouis, Brustzentrum

    Saarlouis, 66740

  • Leopoldina Krankenhaus Schweinfurt, Brustzentrum

    Schweinfurt, 97422

  • Klinikum St. Elisabeth Straubing, Brustzentrum

    Straubing, 94304

  • Katharinen Hospital Unna, Brustzentrum

    Unna, 59423

  • Kliniken Nordoberpfalz, Frauenklinik

    Weiden, 92637

  • Marien-Hospital Wesel, Brustzentrum

    Wesel, 46483

Other trials in Germany

Switzerland1 site

  • Brustzentrum Bern, Engerriedspital/Lindenhofspital

    Bern, 3012

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Being tested
without preoperative access to lymphoscintigraphy findings
Keywords
lymphoscintigraphy, sentinel lymph node biopsy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • without preoperative access to lymphoscintigraphy findingsProcedure or surgery

    axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings

Study groups in NCT02481128
Study groupRoleWhat they receive
A (access to lymphoscintigraphy)No interventionAxillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings
B (no access to lymphoscintigraphy)ExperimentalAxillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings
Receives: Procedure: without preoperative access to lymphoscintigraphy findings

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Rate of patients with proven metastasis in sentinel lymph nodes

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

  2. 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.

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2015 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02481128
Sponsor's protocol ID
SenSzi (GBG80)
Status last verified
Jul 2020
First submitted
5 Jun 2015
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31042410

  • 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.

    PubMed 31465263

Questions about this trial

What is this clinical trial studying?

A study testing without preoperative access to lymphoscintigraphy findings in people with Early-Stage Breast Carcinoma, run by Kliniken Essen-Mitte at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average number of histologically detected sentinel lymph nodes per patient (time frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02481128, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.

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