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
|
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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 |
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 |

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 |
- Disease-free survival [ Time Frame: Five years ]
- Axillary recurrence rate [ Time Frame: Five years ]
- Breast cancer-specific survival [ Time Frame: Five years ]
- Overall survival [ Time Frame: Five years ]

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

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