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Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis (SENOMIC)

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ClinicalTrials.gov Identifier: NCT02049632
Recruitment Status : Recruiting
First Posted : January 30, 2014
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Centrallasarettet Västerås
Uppsala University
Information provided by (Responsible Party):
Jana de Boniface, Karolinska University Hospital

Study Description
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Brief Summary:

Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation.

However, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not.

This Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.


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

Detailed Description:
From April 2017 onwards, only patients operated by mastectomy or those receiving neoadjuvant therapy and having a sentinel node biopsy before its initiation may be recruited into SENOMIC. The inclusion target has been met for those patients operated by breast-conserving therapy, and from now on, these patients will not be included in SENOMIC anymore. Recruitment of the above-mentioned patient selection will continue until 452 patients operated by mastectomy have been enrolled.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 452 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study
Study Start Date : December 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Omission of axillary clearance
No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases
 Procedure: Omission of axillary clearance


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. Axillary recurrence rate [ Time Frame: Five years ]

Other Outcome Measures:
  1. Breast cancer-specific survival [ Time Frame: Five years ]
  2. Overall survival [ Time Frame: Five years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinically node-negative, invasive breast cancer ≤ 5 cm (T1-T2)
  • Histopathology results demonstrate SN micrometastases.
  • Patients who undergo mastectomy (protocol change from April 2017 onwards)
  • The patient must have given verbal and written consent.

Exclusion Criteria:

  • Preoperatively diagnosed lymph node metastases.
  • Sentinel node metastases > 2 mm.
  • Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
  • History of previous breast cancer.
  • Pregnancy.
  • Bilateral breast cancer where any of the other exclusion criteria applies to either side.
  • Medical contraindication for systemic adjuvant therapy
Contacts and Locations
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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): NCT02049632


Contacts
Contact: Jana M de Boniface, Ass.Prof. jana.de-boniface@ki.se
Contact: Jan Frisell, Professor +46851770000 jan.frisell@ki.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Sub-Investigator: Roger Olofsson, MD, PhD         
Helsingborgs Hospital Recruiting
Helsingborg, Sweden
Sub-Investigator: Anna-Karin Falck, MD, PhD         
Kalmar Hospital Recruiting
Kalmar, Sweden
Sub-Investigator: Marie Sundqvist         
Karlskrona Hospital Recruiting
Karlskrona, Sweden
Sub-Investigator: Monika Sjövall         
Kristianstad Hospital Recruiting
Kristianstad, Sweden
Sub-Investigator: Bertil Sjölund         
Lidköping Hospital Recruiting
Lidköping, Sweden
Sub-Investigator: Per Nyman         
Linköping University Hospital Recruiting
Linköping, Sweden
Sub-Investigator: Christina Hedin         
Lund and Malmö University Hospital Recruiting
Lund, Sweden
Sub-Investigator: Lisa Rydén, MD, PhD         
Skövde Hospital Recruiting
Skövde, Sweden
Sub-Investigator: Anja Jungquist         
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Jan M Frisell, Prof    +4685770000    jan.frisell@ki.se   
Principal Investigator: Jan Frisell, Prof         
Capio St Görans Hospital Recruiting
Stockholm, Sweden
Sub-Investigator: Sophie Norenstedt, MD, PhD         
Danderyds Hospital AB Recruiting
Stockholm, Sweden
Sub-Investigator: Kristina Dahlberg, MD, PhD         
Southern General Hospital Recruiting
Stockholm, Sweden
Sub-Investigator: Fuat Celebioglu, MD, PhD         
Sundsvall Hospital Recruiting
Sundsvall, Sweden
Sub-Investigator: Lotta Wadsten         
Uddevalla Hospital Recruiting
Uddevalla, Sweden
Sub-Investigator: Carin Wångblad         
Umeå University Hospital Recruiting
Umeå, Sweden
Sub-Investigator: Malin Sund, Professor         
Akademiska Universitetssjukhuset Recruiting
Uppsala, Sweden
Sub-Investigator: Fredrik Wärnberg, MD, PhD         
Varberg Hospital Recruiting
Varberg, Sweden
Sub-Investigator: Michael Wallberg         
Västervik Hospital Recruiting
Västervik, Sweden
Sub-Investigator: Peter Gustafsson         
Västmanlands Hospital Recruiting
Västerås, Sweden
Contact: Yvette Andersson, MD, PhD       yvette.andersson@ltv.se   
Principal Investigator: Yvette Andersson, MD, PhD         
Växjö Hospital Recruiting
Växjö, Sweden
Sub-Investigator: Lena Myrskog         
Örebro University Hospital Recruiting
Örebro, Sweden
Sub-Investigator: Daniel Tegnelius         
Sponsors and Collaborators
Karolinska Institutet
Centrallasarettet Västerås
Uppsala University
Investigators
Principal Investigator: Jana M de Boniface, MD, PhD Karolinska Institutet
Principal Investigator: Jan Frisell, Professor Karolinska Institutet
Principal Investigator: Leif Bergkvist, Professor Uppsala University
Principal Investigator: Yvette Andersson, MD, PhD Västmanlands Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jana de Boniface, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02049632     History of Changes
Other Study ID Numbers: SENOMIC
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Jana de Boniface, Karolinska University Hospital:
Breast cancer
Sentinel Node Biopsy
Micrometastasis
Axillary lymph node dissection

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Micrometastasis
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes