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

Breast Cancer Clinical Trial

— SENOMIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049632
• Other study ID #: SENOMIC
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Omission of axillary clearance

Locations

Country	Name	City	State
Sweden	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	Capio St Görans Hospital	Stockholm
Sweden	Danderyds Hospital AB	Stockholm
Sweden	Karolinska University Hospital	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	Västmanlands Hospital	Västerås
Sweden	Västervik Hospital	Västervik
Sweden	Växjö Hospital	Växjö

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Centrallasarettet Västerås, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breast cancer-specific survival		Five years
Other	Overall survival		Five years
Primary	Disease-free survival		Five years
Secondary	Axillary recurrence rate		Five years