Studieoverzicht - 2017-03 TRAIN-3

 
Number 2017-03 TRAIN-3
Nickname TRAIN-3
Status Open Date: 27-02-2019
Inclusion closed
Other study number(s)
Participating parties/groups
Full title Image-guided de-escalation of neoadjuvant chemotherapy in HER2-positive breast cancer: the TRAIN-3 study
Phase and type single arm
Age ≥18 woman / man
Menopausal status Not applicable
Indication Neoadjuvant
Subindication HER2+, any HR
Target sample size 462
Actual accrual 0 Date: 27-02-2019
Estimated study completion date 31-12-2022
CCMO approval Yes Date: 08-01-2019 Nr: NL66887.038.18
EudraCT nr. 2018-003275-35
Trial Register NCT03820063
METC approval Yes Date: 07-02-2019 METC: Nederlands Kanker Instituut Nr: M18TRD
Amendments Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website
Sponsor BOOG Study Center
Principal Investigator(s) Dr. GS Sonke MD PhD (The Netherlands Cancer Institute)
Study manager Dr. A.E. van Leeuwen-Stok (BOOG Study Center)

Studycoördinator:
A. van der Voort, MD
T 020-5126169

Central datamanagement and randomization Randomization: Authorized persons at the site, through ALEA

Central contact Data Centre:
I. Mandjes MSc
NKI Data Center
Phone +31 20 512 2880
E-mail i.mandjes@nki.nl
Monitoring NKI Data Center
Phone +31 20 512 2655
E-mail e.v.schaffelaar@nki.nl; r.vd.wiel@nki.nl
Local datamanagement Centrum zelf of IKNL
E-mail trialbureau@iknl.nl
Phone +31 88 234 6500
Funding
Extra Contracts & finances: BOOG Study Center (info@boogstudycenter.nl)

Design:
Objectives:
Endpoints:
Main eligibility criteria:
Documents (public):

Protocol synopsis

Documents (protected):
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