Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02240472
Recruitment Status : Recruiting
First Posted : September 15, 2014
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
The Swedish Research Council
Swedish Cancer Foundation
Nordic Cancer Union
Information provided by (Responsible Party):
Jana de Boniface, Karolinska Institutet

Brief Summary:

Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.

The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years.

This study is a prospective international randomized trial including 3500 patients.

Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Omission of axillary clearance Not Applicable

Detailed Description:
Details can be found on www.senomac.se

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival and Axillary Recurrence Following Sentinel Node-positive Breast Cancer Without Completion Axillary Lymph Node Dissection - a Randomized Study of Patients With Macrometastases in the Sentinel Node
Study Start Date : January 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Axillary clearance
Patients in this arm will be treated by completion axillary clearance after a sentinel node biopsy showing 1-2 nodes with macrometastasis
Experimental: No axillary clearance
Patients in this arm will not undergo further axillary surgery after a sentinel node biopsy showing 1-2 nodes with macrometastasis
Procedure: Omission of axillary clearance
The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis




Primary Outcome Measures :
  1. breast cancer-specific survival [ Time Frame: up to 15 years ]
    death due to breast cancer in both arms measured at a median follow-up of 5, 10 and 15 years


Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: 5, 10 and 15 years ]
    Breast cancer recurrence rate in both arms after a median follow-up of 5, 10 and 15 years

  2. axillary recurrence rate [ Time Frame: 5, 10 and 15 years ]
    The rate of axillary relapse in specific after a median follow-up of 5, 10 and 15 years

  3. overall survival [ Time Frame: 5, 10 and 15 years ]
    The rate of overall deaths after a median follow-up of 5, 10 and 15 years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with invasive breast cancer (T1-T3)
  • N0 on palpation
  • Preoperative ultrasound performed
  • Pathology report shows macrometastasis in 1-2 sentinel lymph nodes
  • Patients undergo breast-conserving therapy or mastectomy
  • The patient must have provided oral and written consent
  • Age ≥ 18 years

Exclusion Criteria:

  • Metastases outside of the ipsilateral axilla
  • Prior history of invasive breast cancer
  • Pregnancy
  • Bilateral breast cancer if one side meets exclusion criteria
  • Medical contraindication for radiotherapy or systemic treatment
  • Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240472


Contacts
Layout table for location contacts
Contact: Jana de Boniface, PhD +46858701000 ext 1804 jana.de-boniface@ki.se
Contact: Leif Bergkvist, Professor +4621173000 leif.bergkvist@ltv.se

Locations
Layout table for location information
Denmark
Sygehus Sonderjylland Recruiting
Aabenraa, Denmark
Contact: Jürgen Handler         
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: ute Hoyer         
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Peer Christiansen         
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Tove Tvedskov Filtenborg         
Sydvestjysk Sygehus Recruiting
Esbjerg, Denmark
Contact: Lena Carstensen         
Sygehus Lillebaelt Recruiting
Lillebaelt, Denmark
Contact: Marianne Lautrup         
Odense University Hospital Recruiting
Odense, Denmark
Contact: Katrine Soe         
Randers Regionshospitalet Recruiting
Randers, Denmark
Contact: Peer Christiansen         
Regionshospitalet Viborg Recruiting
Viborg, Denmark
Contact: Inge Scheel Andersen         
Greece
Athens University Hospital Recruiting
Athens, Greece
Contact: Michalis Kontos         
Sweden
Gävle sjukhus Recruiting
Gävle, Sweden
Contact: Gyula Nagy         
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden
Contact: Roger Olofsson, PhD       roger.olofsson@surgery.gu.se   
Principal Investigator: Roger Olofsson, PhD         
Hallands sjukhus Recruiting
Halmstad, Sweden
Contact: Ann-Christin Källström         
Helsingborg lasarett Recruiting
Helsingborg, Sweden
Contact: Anna-Karin Falck         
Länssjukhuset Ryhov Recruiting
Jönköping, Sweden
Contact: Rebecka Malterling         
Kalmar sjukhus Recruiting
Kalmar, Sweden
Contact: Marie Sundqvist         
Blekinge sjukhuset Recruiting
Karlskrona, Sweden
Contact: Monika Sjövall         
Karlstad sjukhus Recruiting
Karlstad, Sweden
Contact: Lars Ohlsson         
Central Hospital Kristianstad Recruiting
Kristianstad, Sweden
Contact: Shabaz Majid         
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Christina Hedin         
Malmö/Lund University Hospital Recruiting
Lund, Sweden
Contact: Lisa Ryden, PhD       lisa.ryden@skane.se   
Principal Investigator: Lisa Ryden, PhD         
Skaraborgs sjukhus Recruiting
Skövde/Lidköping, Sweden
Contact: Per Nyman         
Contact: Anja Lundberg         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Helena Sackey, PhD    +46851770000    helena.ikonomidis-sackey@sll.se   
Principal Investigator: Helena Sackey, PhD         
Southern Gerenal Hospital Recruiting
Stockholm, Sweden
Contact: Fuat Celebioglu, PhD       fuat.celebioglu@sodersjukhuset.se   
Principal Investigator: Fuat Celebioglu, PhD         
St. Görans Hospital Recruiting
Stockholm, Sweden
Contact: Sophie Norenstedt, PhD       sophie.norenstedt@capiostgoran.se   
Principal Investigator: Sophie Norenstedt, PhD         
Sundsvall länssjukhus Recruiting
Sundsvall, Sweden
Contact: Charlotta Wadsten         
Uddevalla sjukhus Recruiting
Uddevalla, Sweden
Contact: Carin Wångblad         
Umeå University Hospital Recruiting
Umeå, Sweden
Contact: Malin Sund         
Akademiska Sjukhuset Recruiting
Uppsala, Sweden
Contact: Fredrik Wärnberg, PhD       fredrik.warnberg@akademiska.se   
Principal Investigator: Fredrik Wärnberg, PhD         
Varbergs sjukhus Recruiting
Varberg, Sweden
Contact: Michael Wallberg         
Västervik Hospital Recruiting
Västervik, Sweden
Contact: Peter Gustafsson, PhD       peter.gustafsson2@ltkalmar.se   
Principal Investigator: Peter Gustafsson, PhD         
Västerås Central Hospital Recruiting
Västerås, Sweden
Contact: Yvette Andersson, PhD    +4621173000    yvette.andersson@ltv.se   
Principal Investigator: Yvette Andersson, PhD         
Örebro University Hospital Recruiting
Örebro, Sweden
Contact: Marie Wedin         
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Swedish Cancer Foundation
Nordic Cancer Union
Investigators
Layout table for investigator information
Principal Investigator: Jana de Boniface, PhD Karolinska Institutet
Study Chair: Jan Frisell, Professor Karolinska University Hospital
Study Chair: Leif Bergkvist, Professor Central Hospital Västerås
Study Chair: Yvette Andersson, PhD Central Hospital Västerås
Study Chair: Lisa Ryden, Professor Lund University
Study Chair: Malin Sund, Professor Umeå University Hospital
Study Chair: Olofsson Roger, PhD Sahlgrenska University Hospital, Sweden
Study Chair: Johan Ahlgren, PhD Region Örebro County
Study Chair: Dan Lundstedt, PhD Sahlgrenska University Hospital, Sweden
Principal Investigator: Peer Christiansen, Professor Aarhus University Hospital, Denmark
Study Chair: Tove Tvedskov Filtenborg, MD Rigshospitalet Copenhagen, Dnmark
Study Chair: Michalis Kontos, PhD University of Athens
Study Chair: Birgitte Offersen, Professor University of Aarhus
Principal Investigator: Thorsten Kühn, Professor Klinikum Esslingen
Principal Investigator: Toralf Reimer, Professor Universität Rostock
Principal Investigator: Oreste Gentilini San Raffaele Hospital, Milano
Principal Investigator: Roland Reitsamer Universitätsklinikum Salzburg

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Study protocol and patient information (English)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jana de Boniface, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02240472     History of Changes
Other Study ID Numbers: SENOMAC
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

Keywords provided by Jana de Boniface, Karolinska Institutet:
sentinel node biopsy, lymph node metastasis, survival

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases