Clinical trial NCT02049632: Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Sentinel Node Biopsy
Micrometastasis
Axillary lymph node dissection
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Centrallasarettet Västerås
name: Uppsala University
First posted: 2014-01-30
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: Five years
Secondary outcomes:
measure: Axillary recurrence rate
timeFrame: Five years
Other outcomes:
measure: Breast cancer-specific survival
timeFrame: Five years
measure: Overall survival
timeFrame: Five years
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Helsingborg
country: Sweden
facility: Helsingborgs Hospital
city: Kalmar
country: Sweden
facility: Kalmar Hospital
city: Karlskrona
country: Sweden
facility: Karlskrona Hospital
city: Kristianstad
country: Sweden
facility: Kristianstad Hospital
city: Lidköping
country: Sweden
facility: Lidköping Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Lund and Malmö University Hospital
city: Skövde
country: Sweden
facility: Skövde Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Capio St Görans Hospital
city: Stockholm
country: Sweden
facility: Danderyds Hospital AB
city: Stockholm
country: Sweden
facility: Southern General Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
city: Uppsala
country: Sweden
facility: Akademiska Universitetssjukhuset
city: Varberg
country: Sweden
facility: Varberg Hospital
city: Västervik
country: Sweden
facility: Västervik Hospital
city: Västerås
country: Sweden
facility: Västmanlands Hospital
city: Växjö
country: Sweden
facility: Växjö Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Jana M de Boniface, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Jan Frisell, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Leif Bergkvist, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Västmanlands Hospital
name: Yvette Andersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: