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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 October 2023
Main ID:	NCT02240472
Date of registration:	11/09/2014
Prospective Registration:	Yes
Primary sponsor:	Karolinska Institutet
Public title:	Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.
Scientific 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
Date of first enrolment:	January 27, 2015
Target sample size:	2700
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02240472
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Denmark	Greece	Sweden

Contacts

Name:	Dan Lundstedt, PhD
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Affiliation:	Sahlgrenska University Hospital, Sweden

Name:	Yvette Andersson, PhD
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Affiliation:	Central Hospital Västerås

Name:	Thorsten Kühn, Professor
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Affiliation:	Klinikum Esslingen

Name:	Oreste Gentilini
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Affiliation:	San Raffaele Hospital, Milano

Name:	Michalis Kontos, PhD
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Affiliation:	University of Athens

Name:	Tove Tvedskov Filtenborg, MD
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Affiliation:	Rigshospitalet Copenhagen, Dnmark

Name:	Olofsson Roger, PhD
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Affiliation:	Sahlgrenska University Hospital, Sweden

Name:	Leif Bergkvist, Professor
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Affiliation:	Central Hospital Västerås

Name:	Toralf Reimer, Professor
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Affiliation:	Universität Rostock

Name:	Jana de Boniface, PhD
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Affiliation:	Karolinska Institutet

Name:	Lisa Ryden, Professor
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Affiliation:	Lund University

Name:	Malin Sund, Professor
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Affiliation:	Umeå University Hospital

Name:	Roland Reitsamer
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Affiliation:	Universitätsklinikum Salzburg

Name:	Birgitte Offersen, Professor
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Affiliation:	University of Aarhus

Name:	Peer Christiansen, Professor
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Affiliation:	Aarhus University Hospital, Denmark

Name:	Jan Frisell, Professor
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Affiliation:	Karolinska University Hospital

Name:	Johan Ahlgren, PhD
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Affiliation:	Region Örebro County

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Procedure: Omission of axillary clearance

Primary Outcome(s)

breast cancer-specific survival [Time Frame: up to 15 years]

Secondary Outcome(s)

axillary recurrence rate [Time Frame: 5, 10 and 15 years]

disease-free survival [Time Frame: 5, 10 and 15 years]

overall survival [Time Frame: 5, 10 and 15 years]

Secondary ID(s)

SENOMAC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swedish Cancer Foundation

Nordic Cancer Union

The Swedish Research Council

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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