Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.
Launched by KAROLINSKA INSTITUTET · Sep 12, 2014
Trial Information
Current as of April 30, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether it is safe for breast cancer patients to skip a surgery called axillary clearance (removal of additional lymph nodes from the armpit) if their sentinel node biopsy shows that 1-2 lymph nodes have larger tumor deposits, known as macrometastasis. The goal is to see if not doing this extra surgery affects patients' survival rates in a significant way over five years. Researchers believe that avoiding this surgery could reduce complications, such as swelling and pain in the arm, while still providing effective treatment for breast cancer.
To be eligible for the trial, patients must have invasive breast cancer but show no signs of cancer spread to the lymph nodes during a physical exam. They should also have a preoperative ultrasound and a pathology report that confirms macrometastasis in 1-2 sentinel lymph nodes. Participants will be randomly assigned to either have the axillary clearance surgery or not. Throughout the study, researchers will monitor important outcomes like survival rates and the recurrence of cancer in the axillary area. This trial includes 3,500 patients and is currently active but not recruiting new participants.
Gender
ALL
Eligibility criteria
- 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.
About Karolinska Institutet
Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Odense, , Denmark
Aarhus, , Denmark
Uppsala, , Sweden
Göteborg, , Sweden
Stockholm, , Sweden
Linköping, , Sweden
Aalborg, , Denmark
örebro, , Sweden
Umeå, , Sweden
Uddevalla, , Sweden
Västervik, , Sweden
örebro, , Sweden
Gävle, , Sweden
Viborg, , Denmark
Halmstad, , Sweden
Jönköping, , Sweden
Karlstad, , Sweden
Esbjerg, , Denmark
Aabenraa, , Denmark
Lillebaelt, , Denmark
Randers, , Denmark
Athens, , Greece
Helsingborg, , Sweden
Kalmar, , Sweden
Karlskrona, , Sweden
Kristianstad, , Sweden
Lund, , Sweden
Skövde/Lidköping, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Varberg, , Sweden
Västerås, , Sweden
Patients applied
Trial Officials
Jana de Boniface, PhD
Principal Investigator
Karolinska Institutet
Jan Frisell, Professor
Study Chair
Karolinska University Hospital
Leif Bergkvist, Professor
Study Chair
Central Hospital Västerås
Yvette Andersson, PhD
Study Chair
Central Hospital Västerås
Lisa Ryden, Professor
Study Chair
Lund University
Malin Sund, Professor
Study Chair
Umeå University Hospital
Olofsson Roger, PhD
Study Chair
Sahlgrenska University Hospital
Johan Ahlgren, PhD
Study Chair
Region Örebro County
Dan Lundstedt, PhD
Study Chair
Sahlgrenska University Hospital
Peer Christiansen, Professor
Principal Investigator
Aarhus University Hospital, Denmark
Tove Tvedskov Filtenborg, MD
Study Chair
Rigshospitalet Copenhagen, Dnmark
Michalis Kontos, PhD
Study Chair
University of Athens
Birgitte Offersen, Professor
Study Chair
University of Aarhus
Thorsten Kühn, Professor
Principal Investigator
Klinikum Esslingen
Toralf Reimer, Professor
Principal Investigator
Universität Rostock
Oreste Gentilini
Principal Investigator
San Raffaele Hospital, Milano
Roland Reitsamer
Principal Investigator
Universitätsklinikum Salzburg
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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