Clinical Research Directory
Browse clinical research sites, groups, and studies.
Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients with RCR and PCR in the Breast After NAST
Sponsor: Toralf Reimer, MD PhD
Summary
Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on this, the postsurgical therapy should be considered on the basis of biologic tumor characteristics rather than nodal involvement. Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to decrease, and perhaps eliminate, surgery in patients who have a pCR. The investigators designed a clinical trial in which only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) will be included and type of surgery will be defined according to the response to NAST rather than on the classical T and N status at presentation. In the planned trial, axillary surgery will be eliminated completely (no axillary sentinel lymph node biopsy \[SLNB\]) for initially cN0 patients with radiologic complete remission (rCR) and a breast pCR as determined in the lumpectomy specimen. The trial design is a multicenter single-arm study with a limited number of patients (N=350) which might give practice-changing results in a short period of time, sparing the time and the costs of a randomized comparison. Patients will be recruited in European countries (Austria, Germany, Italy, and Spain) over a period of 48 months.
Official title: Omission of Sentinel Lymph Node Biopsy in Triple-negative and HER2-positive Breast Cancer Patients with Radiologic and Pathologic Complete Response in the Breast After Neoadjuvant Systemic Therapy: a Single-arm, Prospective Surgical Trial.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2021-01-13
Completion Date
2028-01
Last Updated
2025-01-07
Healthy Volunteers
No
Conditions
Interventions
omission of SLNB
After radiologic complete remission at the end of NAST all patients will be treated with breast-conserving surgery alone without any axillary surgery.
Locations (40)
Med. Universität Graz, Frauenklinik
Graz, Austria
Praxis Dres. Heinrich & Bangerter
Augsburg, Germany
Universitäts-Klinikum, Frauenklinik
Augsburg, Germany
Klinikum Mittelbaden Brustzentrum
Baden-Baden, Germany
DRK Kliniken Köpenick, Brustzentrum
Berlin, Germany
Evang. Waldkrankenhaus Spandau, Brustzentrum
Berlin, Germany
Sana Klinikum Lichtenberg
Berlin, Germany
Augusta-Klinik Brustzentrum
Bochum, Germany
Brustzentrum Nordsachsen, Frauenklinik
Borna, Germany
Marienhospital, Klinik für Gynäkologie
Bottrop, Germany
Kreiskliniken Böblingen, Frauenklinik
Böblingen, Germany
Carl-Thiem-Klinikum, Frauenklinik
Cottbus, Germany
Diakonissen-Krankenhaus Brustzentrum
Dresden, Germany
Brustzentrum Kreisklinik Ebersberg
Ebersberg, Germany
Uni-Klinikum Essen, Frauenklinik
Essen, Germany
Klinikum Esslingen, Frauenklinik
Esslingen am Neckar, Germany
Agaplesion Diakonie Klinikum, Frauenklinik
Hamburg, Germany
Albertinen Krankenhaus, Gynäkologie
Hamburg, Germany
Sana Klinikum Hameln-Pyrmont
Hamelin, Germany
Klinikum Hanau GmbH, Frauenklinik
Hanau, Germany
Brustzentrum Klinikum Siloah
Hanover, Germany
Medizinische Hochschule Hannover, Frauenklinik
Hanover, Germany
Universitätsklinikum Heidelberg, Frauenklinik
Heidelberg, Germany
ViDia Christliche Kliniken, Frauenklinik
Karlsruhe, Germany
Elisabeth Krankenhaus, Brustzentrum
Kassel, Germany
Universitäts-Klinikum Magdeburg, Frauenklinik
Magdeburg, Germany
Ludmillenstift, Brustzentrum
Meppen, Germany
Klinikum Passau, Frauenklinik
Passau, Germany
Universitäts-Frauenklinik am Klinikum Südstadt
Rostock, Germany
Helios Klinik, Gynäkologie
Schkeuditz, Germany
Helios Kliniken Schwerin, Frauenklinik
Schwerin, Germany
Diakonissen-Stiftungs-Krankenhaus, Gynäkologie
Speyer, Germany
Johanniter-Krankenhaus, Frauenklinik
Stendal, Germany
Asklepios Paulinen Klinik, Frauenklinik
Wiesbaden, Germany
Helios HSK, Brustzentrum
Wiesbaden, Germany
St. Josefs-Hospital, Frauenklinik
Wiesbaden, Germany
Rems-Murr-Klinik, Frauenklinik
Winnenden, Germany
Stadtkrankenhaus Worms gGmbH, Brustzentrum
Worms, Germany
San Raffaele Hospital, Breast Unit
Milan, Italy
Universidad de Navarra
Madrid, Spain