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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Jana de Boniface, Karolinska University Hospital
Sponsor:
Collaborators:
Karolinska Institutet
Centrallasarettet Västerås
Uppsala University
Information provided by (Responsible Party):
Jana de Boniface, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT02049632
First received: January 24, 2014
Last updated: April 20, 2017
Last verified: April 2017

January 24, 2014
April 20, 2017
December 2013
December 2019   (Final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: Five years ]
Same as current
Complete list of historical versions of study NCT02049632 on ClinicalTrials.gov Archive Site
Axillary recurrence rate [ Time Frame: Five years ]
Same as current
  • Breast cancer-specific survival [ Time Frame: Five years ]
  • Overall survival [ Time Frame: Five years ]
Same as current
 
Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Breast Cancer
Procedure: Omission of axillary clearance
Experimental: Omission of axillary clearance
No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases
Intervention: Procedure: Omission of axillary clearance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
452
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jana M de Boniface, MD, PhD +46851770000 jana.deboniface@karolinska.se
Contact: Jan Frisell, Professor +46851770000 jan.frisell@ki.se
Sweden
 
 
NCT02049632
SENOMIC
Yes
Not Provided
Not Provided
Not Provided
Jana de Boniface, Karolinska University Hospital
Karolinska University Hospital
  • Karolinska Institutet
  • Centrallasarettet Västerås
  • Uppsala University
Principal Investigator: Jana M de Boniface, MD, PhD Karolinska University Hospital
Principal Investigator: Jan Frisell, Professor Karolinska Institutet
Principal Investigator: Leif Bergkvist, Professor Uppsala University
Principal Investigator: Yvette Andersson, MD, PhD Västmanlands Hospital
Karolinska University Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP