Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
NCT ID: NCT02049632
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
805 participants
INTERVENTIONAL
2013-12-31
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Omission of axillary clearance
No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases
Omission of axillary clearance
Interventions
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Omission of axillary clearance
Eligibility Criteria
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Inclusion Criteria
* 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
* Sentinel node metastases \> 2 mm.
* Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
* History of previous breast cancer.
* Pregnancy.
* Medical contraindication for systemic adjuvant therapy
18 Years
ALL
No
Sponsors
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Centrallasarettet Västerås
OTHER
Uppsala University
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Jana de Boniface
MD, PhD
Principal Investigators
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Jana M de Boniface, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Jan Frisell, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Leif Bergkvist, Professor
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Yvette Andersson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Västmanlands Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Helsingborgs Hospital
Helsingborg, , Sweden
Kalmar Hospital
Kalmar, , Sweden
Karlskrona Hospital
Karlskrona, , Sweden
Kristianstad Hospital
Kristianstad, , Sweden
Lidköping Hospital
Lidköping, , Sweden
Linköping University Hospital
Linköping, , Sweden
Lund and Malmö University Hospital
Lund, , Sweden
Örebro University Hospital
Örebro, , Sweden
Skövde Hospital
Skövde, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Capio St Görans Hospital
Stockholm, , Sweden
Danderyds Hospital AB
Stockholm, , Sweden
Southern General Hospital
Stockholm, , Sweden
Sundsvall Hospital
Sundsvall, , Sweden
Uddevalla Hospital
Uddevalla, , Sweden
Umeå University Hospital
Umeå, , Sweden
Akademiska Universitetssjukhuset
Uppsala, , Sweden
Varberg Hospital
Varberg, , Sweden
Växjö Hospital
Vaxjo, , Sweden
Västmanlands Hospital
Västerås, , Sweden
Västervik Hospital
Västervik, , Sweden
Countries
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Other Identifiers
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SENOMIC
Identifier Type: -
Identifier Source: org_study_id
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