Studieoverzicht - 2016-01 TOP-1

 
Number 2016-01 TOP-1
Nickname TOP-1
Status Open Date: 24-11-2016
Inclusion closed
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
Actual accrual 185 Date: 08-02-2019
Estimated study completion date
CCMO approval Date: Nr:
EudraCT nr.
Trial Register
METC approval Yes Date: 24-11-2016 METC: Leiden Universitair Medisch Centrum Nr:
Amendments Yes Date: 08-02-2018
KWF-CKS approval Yes Date: 18-12-2015 Nr: TDM-Hi/8o5G
News item
Website https://www.boogstudycenter.nl/studie/283/top-1.html
Sponsor Leids Universitair Medisch Centrum
Principal Investigator(s) G.J. Liefers, MD, PhD (LUMC)
Study manager J. Braak (datacenter LUMC)
J. Rademaker-Lakhai (BOOG sc)
Central datamanagement and randomization Datacenter Heelkunde, 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
datacenter@lumc.nl | 003171-5263500
Monitoring
Local datamanagement Door het IKNL (alleen NKI zelf)
Funding KWF
Extra

Design:

Objectives:

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.

Endpoints:

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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