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

History of Changes

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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 March 01, 2015

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