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

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Trial Identification

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

Study ID: NCT02240472

Conditions

Breast Cancer

Study Description

Brief 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.

Detailed Description: Details can be found on www.senomac.se

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, , Denmark

Athens University Hospital, Athens, , Greece

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

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

Västervik Hospital, Västervik, , Sweden

Västerås Central Hospital, Västerås, , Sweden

Örebro University Hospital, Örebro, , Sweden

Contact Details

Name: Jana de Boniface, PhD

Affiliation: Karolinska Institutet

Role: PRINCIPAL_INVESTIGATOR

Name: Jan Frisell, Professor

Affiliation: Karolinska University Hospital

Role: STUDY_CHAIR

Name: Leif Bergkvist, Professor

Affiliation: Central Hospital Västerås

Role: STUDY_CHAIR

Name: Yvette Andersson, PhD

Affiliation: Central Hospital Västerås

Role: STUDY_CHAIR

Name: Lisa Ryden, Professor

Affiliation: Lund University

Role: STUDY_CHAIR

Name: Malin Sund, Professor

Affiliation: Umeå University Hospital

Role: STUDY_CHAIR

Name: Olofsson Roger, PhD

Affiliation: Sahlgrenska University Hospital, Sweden

Role: STUDY_CHAIR

Name: Johan Ahlgren, PhD

Affiliation: Region Örebro County

Role: STUDY_CHAIR

Name: Dan Lundstedt, PhD

Affiliation: Sahlgrenska University Hospital, Sweden

Role: STUDY_CHAIR

Name: Peer Christiansen, Professor

Affiliation: Aarhus University Hospital, Denmark

Role: PRINCIPAL_INVESTIGATOR

Name: Tove Tvedskov Filtenborg, MD

Affiliation: Rigshospitalet Copenhagen, Dnmark

Role: STUDY_CHAIR

Name: Michalis Kontos, PhD

Affiliation: University of Athens

Role: STUDY_CHAIR

Name: Birgitte Offersen, Professor

Affiliation: University of Aarhus

Role: STUDY_CHAIR

Name: Thorsten Kühn, Professor

Affiliation: Klinikum Esslingen

Role: PRINCIPAL_INVESTIGATOR

Name: Toralf Reimer, Professor

Affiliation: Universität Rostock

Role: PRINCIPAL_INVESTIGATOR

Name: Oreste Gentilini

Affiliation: San Raffaele Hospital, Milano

Role: PRINCIPAL_INVESTIGATOR

Name: Roland Reitsamer

Affiliation: Universitätsklinikum Salzburg

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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