Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

Breast Cancer Clinical Trial

Official title:

Survival and Axillary Recurrence Following Sentinel Node-positive Breast Cancer Without Completion Axillary Lymph Node Dissection - a Randomized Study of Patients With Macrometastases in the Sentinel Node

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02240472
• Other study ID #: SENOMAC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 27, 2015
• Est. completion date: December 31, 2026

Study information

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

Clinical Trial Summary

Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.

The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years.

This study is a prospective international randomized trial including 3500 patients.

Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.

Description:

Details can be found on www.senomac.se

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2700
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with invasive breast cancer (T1-T3)

• N0 on palpation

• Preoperative ultrasound performed

• Pathology report shows macrometastasis in 1-2 sentinel lymph nodes

• Patients undergo breast-conserving therapy or mastectomy

• The patient must have provided oral and written consent

• Age = 18 years

Exclusion Criteria:

• Metastases outside of the ipsilateral axilla

• Prior history of invasive breast cancer

• Pregnancy

• Bilateral breast cancer if one side meets exclusion criteria

• Medical contraindication for radiotherapy or systemic treatment

• Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Omission of axillary clearance
The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis

Locations

Country	Name	City	State
Denmark	Sygehus Sonderjylland	Aabenraa
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Sydvestjysk Sygehus	Esbjerg
Denmark	Sygehus Lillebaelt	Lillebaelt
Denmark	Odense University Hospital	Odense
Denmark	Randers Regionshospitalet	Randers
Denmark	Regionshospitalet Viborg	Viborg
Greece	Athens University Hospital	Athens
Sweden	Gävle sjukhus	Gävle
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Hallands sjukhus	Halmstad
Sweden	Helsingborg lasarett	Helsingborg
Sweden	Länssjukhuset Ryhov	Jönköping
Sweden	Kalmar sjukhus	Kalmar
Sweden	Blekinge sjukhuset	Karlskrona
Sweden	Karlstad sjukhus	Karlstad
Sweden	Central Hospital Kristianstad	Kristianstad
Sweden	Linköping University Hospital	Linköping
Sweden	Malmö/Lund University Hospital	Lund
Sweden	Örebro University Hospital	Örebro
Sweden	Skaraborgs sjukhus	Skövde/Lidköping
Sweden	Karolinska University Hospital	Stockholm
Sweden	Southern Gerenal Hospital	Stockholm
Sweden	St. Görans Hospital	Stockholm
Sweden	Sundsvall länssjukhus	Sundsvall
Sweden	Uddevalla sjukhus	Uddevalla
Sweden	Umeå University Hospital	Umeå
Sweden	Akademiska Sjukhuset	Uppsala
Sweden	Varbergs sjukhus	Varberg
Sweden	Västerås Central Hospital	Västerås
Sweden	Västervik Hospital	Västervik

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Nordic Cancer Union, Swedish Cancer Foundation, The Swedish Research Council

Countries where clinical trial is conducted

Denmark,  Greece,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast cancer-specific survival	death due to breast cancer in both arms measured at a median follow-up of 5, 10 and 15 years	up to 15 years
Secondary	disease-free survival	Breast cancer recurrence rate in both arms after a median follow-up of 5, 10 and 15 years	5, 10 and 15 years
Secondary	axillary recurrence rate	The rate of axillary relapse in specific after a median follow-up of 5, 10 and 15 years	5, 10 and 15 years
Secondary	overall survival	The rate of overall deaths after a median follow-up of 5, 10 and 15 years	5, 10 and 15 years

External Links

•   study homepage