Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
NCT ID: NCT04486495
Last Updated: 2022-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
549 participants
OBSERVATIONAL
2020-07-16
2027-07-01
Brief Summary
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Detailed Description
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Patients who are included in this study will complete Patient Reported Outcome Measures (PROMs) at baseline (time of diagnosis), and 1 and 5 years after diagnosis to assess impact on QoL.
A database will be built by the Netherlands Cancer Registry. Data on patient-, tumor-, pre-NST staging-, post-NST staging- and treatment-characteristics will be retrieved from patients' records by trained data registrars of the Netherlands Comprehensive Cancer Organisation (IKNL) using electronic case report forms (eCRFs). Five-year survival and recurrence will be evaluated to determine oncologic safety.
The results will be incorporated in the national guidelines. In case of an equilibrium between less and more invasive strategies, the data of this study will at least be extremely suitable to be used in the shared decision making process.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Pathologically proven positive axillary lymph node
* Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla
Exclusion Criteria
* Bilateral invasive breast cancer
* Neoadjuvant endocrine therapy
* Distant metastases (including oligometastatic disease)
* History of invasive breast cancer
* Other malignancies, except for basal/squamous cell skin cancer, and in situ carcinoma of the cervix or breast
* Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)
18 Years
FEMALE
No
Sponsors
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Erasmus Medical Center
OTHER
The Netherlands Cancer Institute
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marjolein Smidt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Marie-Jeanne Vrancken Peeters, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Linetta Koppert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Northwest Clinics
Alkmaar, , Netherlands
The Netherlands Cancer Institute
Amsterdam, , Netherlands
Gelre Hospital
Apeldoorn, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Red Cross Hospital
Beverwijk, , Netherlands
Alexander Monro Hospital
Bilthoven, , Netherlands
Amphia Hospital
Breda, , Netherlands
Van Weel-Bethesda
Dirksland, , Netherlands
Slingeland Hospital
Doetinchem, , Netherlands
Albert Schweitzer Hospital
Dordrecht, , Netherlands
Gelderse Vallei Hospital
Ede, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Máxima Medical Center
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Martini Hospital
Groningen, , Netherlands
Saxenburgh Medical Center
Hardenberg, , Netherlands
Ziekenhuisgroep Twente
Hengelo, , Netherlands
Tergooi Hospital
Hilversum, , Netherlands
Spaarne Gasthuis
Hoofddorp, , Netherlands
Dijklander Hospital
Hoorn, , Netherlands
Medical Center Leeuwarden
Leeuwarden, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Alrijne Hospital
Leiderdorp, , Netherlands
Haaglanden Medical Center
Leidschendam, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Canisius Wilhelmina Hospital
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Franciscus Gasthuis
Rotterdam, , Netherlands
Ikazia Hospital
Rotterdam, , Netherlands
Maasstad Hospital
Rotterdam, , Netherlands
Spijkenisse Medical Center
Spijkenisse, , Netherlands
ZorgSaam Hospital
Terneuzen, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Isala Hospital
Zwolle, , Netherlands
Countries
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Central Contacts
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Other Identifiers
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2020-12518
Identifier Type: -
Identifier Source: org_study_id
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