Studieoverzicht - 2016-01 TOP-1

Number 2016-01 TOP-1
Nickname TOP-1
Status Follow up Date: 01-01-2023
Inclusion closed 31-12-2022
Other study number(s)
Participating parties/groups
Full title Tailored treatment in Older Patients TOP-1: Omission of radiotherapy in elderly patients with low risk breast cancer
Phase and type Observational
Age > 70
Menopausal status Postmenopausal
Indication Data registration
Subindication HER2- HR+
Target sample size 800-> wordt verhoogd
Actual accrual 1182 Date: 26-06-2023
Estimated study completion date
CCMO approval Not applicable Date: Nr:
EudraCT nr.
Trial Register NTR 6147
METC approval Yes Date: 24-11-2016 METC: Leiden Universitair Medisch Centrum Nr: NL 58117.058.16
Amendments Yes Date: 01-01-2022
KWF-CKS approval Yes Date: 18-12-2015 Nr: UL2015-8056
News item
Website , voor patienten:
Sponsor Leids Universitair Medisch Centrum
Principal Investigator(s) G.J. Liefers, MD, PhD (LUMC)
Study manager J. Braak (datacenter LUMC)
E. van Leeuwen-Stok (BOOG sc)
Central datamanagement and randomization 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 | 003171-5263500
Local datamanagement IKNL (alleen NKI zelf)
Funding KWF: UL2015-8056
Extra Registratie is uitgebreid na 800 patiënten tot 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.



Primary Objective: To determine if radiotherapy (RT) can safely be omitted after breast
conserving 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 endpoints: the local recurrence rate (LRR)
at 5 years. Secondary endpoint: distant metastases free survival (DMFS), breast
cancer-specific survival (BCSS) and overall survival (OS), quality of life, side-effects, costs,
cosmetic outcome, geriatric assessment and biomarkers.

Main eligibility criteria:

Inclusion criteria:

- age 70 years or older;
- within 3 months after BCS;
- tumor <1 cm grade 1-2 or tumor 1-2cm grade 1;
- tumor ER>50% positive, HER2 negative;
- sN0 or sN0(itc);
- R0 resection;

- female.


Exclusion criteria:

- Indication for hormornal therapy;

- Bilateral

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