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Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis

NCT02049632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2023-03-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Omission of axillary clearance

Sponsors & Collaborators

  • Centrallasarettet Västerås

    collaborator OTHER

  • Uppsala University

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Jana M de Boniface, MD, PhD · Karolinska Institutet

  • Jan Frisell, Professor · Karolinska Institutet

  • Leif Bergkvist, Professor · Uppsala University

  • Yvette Andersson, MD, PhD · Västmanlands Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02049632 on ClinicalTrials.gov