Clinical Trial: Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
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 Summary: 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.
Sponsor: Karolinska University Hospital
Current Primary Outcome: Disease-free survival [ Time Frame: Five years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Axillary recurrence rate [ Time Frame: Five years ]
Original Secondary Outcome: Same as current
Information By: Karolinska University Hospital
Dates:
Date Received: January 24, 2014
Date Started: December 2013
Date Completion: December 2019
Last Updated: April 20, 2017
Last Verified: April 2017
