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Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis (SENOMIC)
This study is currently recruiting participants.
Verified August 2017 by Jana de Boniface, Karolinska University Hospital
Sponsor:
Karolinska Institutet
Collaborators:
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: August 30, 2017
Last verified: August 2017
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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: | 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 |
Resource links provided by NLM:
Further study details as provided by Jana de Boniface, Karolinska University Hospital:
Primary Outcome Measures:
- Disease-free survival [ Time Frame: Five years ]
Secondary Outcome Measures:
- Axillary recurrence rate [ Time Frame: Five years ]
Other Outcome Measures:
- Breast cancer-specific survival [ Time Frame: Five years ]
- Overall survival [ Time Frame: Five years ]
| Estimated Enrollment: | 452 |
| Study Start Date: | December 2013 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2019 (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 |
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.
Eligibility| 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02049632
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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: | August 30, 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 |
ClinicalTrials.gov processed this record on September 21, 2017