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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 October 2014 by 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: October 22, 2014
Last verified: October 2014
  Purpose

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 Intervention
Breast Cancer
Procedure: Omission of axillary clearance

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Axillary recurrence rate [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Breast cancer-specific survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 452
Study Start Date: December 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omission of axillary clearance
No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases
Procedure: Omission of axillary clearance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 breast-conserving surgery or mastectomy.
  • 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.
  • Neoadjuvant therapy.
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049632

Contacts
Contact: Jana M de Boniface, MD, PhD +46851770000 jana.deboniface@karolinska.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         
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         
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Jana M de Boniface, MD, PhD    +4685770000    jana.deboniface@karolinska.se   
Principal Investigator: Jana M de Boniface, 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 University Hospital
Karolinska Institutet
Centrallasarettet Västerås
Uppsala University
Investigators
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
  More Information

No publications provided

Responsible Party: Jana de Boniface, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02049632     History of Changes
Other Study ID Numbers: SenOMic
Study First Received: January 24, 2014
Last Updated: October 22, 2014
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014