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Trial record 1 of 1 for:    senomac
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Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

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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

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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

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

Locations
Show Show 33 study locations
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Swedish Cancer Foundation
Nordic Cancer Union
Investigators
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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):
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Responsible Party: Jana de Boniface, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02240472    
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases