Spots Global Cancer Trial Database for Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
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Trial Identification
Brief Title: 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 ID: NCT02049632
Conditions
Interventions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Skövde Hospital, Skövde, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Capio St Görans Hospital, Stockholm, , Sweden
Danderyds Hospital AB, 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
Västervik Hospital, Västervik, , Sweden
Västmanlands Hospital, Västerås, , Sweden
Växjö Hospital, Växjö, , Sweden
Örebro University Hospital, Örebro, , Sweden
Contact Details
Name: Jana M de Boniface, MD, PhD
Affiliation: Karolinska Institutet
Role: PRINCIPAL_INVESTIGATOR
Name: Jan Frisell, Professor
Affiliation: Karolinska Institutet
Role: PRINCIPAL_INVESTIGATOR
Name: Leif Bergkvist, Professor
Affiliation: Uppsala University
Role: PRINCIPAL_INVESTIGATOR
Name: Yvette Andersson, MD, PhD
Affiliation: Västmanlands Hospital
Role: PRINCIPAL_INVESTIGATOR
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