Leids Universitair Medisch Centrum
G.J. Liefers, MD, PhD (LUMC)
J. Braak (datacenter LUMC), E. van Leeuwen-Stok (BOOG SC)
Clinical Research Center LUMC
Ir. W.M. Meershoek – Klein Kranenbarg & Ing. J.P.B.M. Braak
J-10-070, K6-R
Postbus 9600
2300 RC Leiden
The Netherlands
ClinicalResearchCenter@lumc.nl
ClinicalResearchCenter@lumc.nl. | 003171-5263500
IKNL (alleen NKI zelf)
KWF: UL2015-8056
Inclusieduur en aantal is uitgebreid tot het moment dat de eerste 800 patiënten (geïncludeerd t/m augustus 2021) tenminste 1 follow-up moment van 12 maanden hebben bereikt. De studie is gesloten voor inclusie per 31 december 2022.
Onderzoekersgeïnitieerde prospectieve registratiestudie (zonder randomisatie, één arm)
Primary objective
To determine if radiotherapy (RT) can safely be omitted after breastconserving surgery (BCS) in elderly patients at low risk of developing a local recurrence (LR)
Secondary objectives
Assessment of: quality of life, toxicity, geriatric assessment, overall- and breast cancer specific survival, distant metastasis free survival, relating biomarkers to outcome (tumor characteristics, at least: IHC ER, PR, HER2 and Ki-67), additional state of the art molecular analysis if possible, development and validation of local recurrence rate prediction models, (cost) efficacy (comparison with historical control group) and implementation of findings into standard care.
Primary endpoint
Local recurrence rate (LRR) at 5 years
Secondary endpoints
Distant metastases free survival (DMFS), breast cancer-specific survival (BCSS), overall survival (OS), quality of life, side-effects, costs, cosmetic outcome, geriatric assessment, biomarkers
Inclusion criteria
Exclusion criteria
