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

Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 805
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
  • Helsingborg, Sweden
    • Helsingborgs Hospital
  • Kalmar, Sweden
    • Kalmar Hospital
  • Karlskrona, Sweden
    • Karlskrona Hospital
  • Kristianstad, Sweden
    • Kristianstad Hospital
  • Lidköping, Sweden
    • Lidkoping Hospital
  • Linköping, Sweden
    • Linkoping University Hospital
  • Lund, Sweden
    • Lund and Malmö University Hospital
  • Skövde, Sweden
    • Skövde Hospital
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital
  • Stockholm, Sweden
    • Capio St Görans Hospital
  • Stockholm, Sweden
    • Danderyds Hospital AB
  • Stockholm, Sweden
    • Southern General Hospital
  • Sundsvall, Sweden
    • Sundsvall Hospital
  • Uddevalla, Sweden
    • Uddevalla Hospital
  • Umeå, Sweden
    • Umea University Hospital
  • Uppsala, Sweden
    • Akademiska Universitetssjukhuset
  • Varberg, Sweden
    • Varberg Hospital
  • Västervik, Sweden
    • Västervik Hospital
  • Västerås, Sweden
    • Västmanlands Hospital
  • Växjö, Sweden
    • Växjö Hospital
  • Örebro, Sweden
    • Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	Five years

Secondary Outcome Measures

Outcome Measure	Time Frame
Axillary recurrence rate	Five years

Other Outcome Measures

Outcome Measure	Time Frame
Overall survival	Five years
Breast cancer-specific survival	Five years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Uppsala University; Centrallasarettet Västerås
• 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

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Axillary lymph node dissection; Micrometastasis; Sentinel Node Biopsy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasm Metastasis; Breast Neoplasms; Neoplasm Micrometastasis
• Other Study ID Numbers: SENOMIC