Studieoverzicht - 2016-02 PALLAS

 
Number 2016-02 PALLAS
Nickname PALLAS
Status Follow up Date: 30-11-2018
Inclusion closed 30-11-2018
Other study number(s) ABCSG 42, BIG 14-03
Participating parties/groups ABCSG, BIG
Full title PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer
Phase and type Randomized Phase III
Age ≥ 18, woman/man
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication HER2- HR+
Target sample size 3125
Actual accrual 3381(NL: 25) Date: 30-11-2018
Estimated study completion date 15-11-2018
CCMO approval Date: Nr:
EudraCT nr. 2014-005181-30
Trial Register NCT02513394
METC approval Yes Date: 14-12-2016 METC: Nr:
Amendments Date:
KWF-CKS approval Date: Nr:
News item
Website http://pallastrial.org/
Sponsor BOOG
Principal Investigator(s)
Study manager
Central datamanagement and randomization
Monitoring
Local datamanagement
Funding
Extra

Design:

Objectives:
Endpoints:

Primair eindpunt

Invasive disease-free survival (iDFS) voor de combinatie van min. 5 jaar HT plus 2 jaar palbociclib t versus min. 5 jaar HT alleen

 

Secundaire eindpunten

  • iDFS excludief tweede primaire tumoren(niet-borstkanker) , distant disease-free survival (DDFS), locoregional recurrences-free survival (LRRFS), overall survival (OS);
  • Safety voor de combinatie van min. 5 jaar HT plus 2 jaar palbociclib t versus min. 5 jaar HT alleen;
  • Evaluate iDFS en OS in genomisch-gedefinieerde borstkanker subgroepen gebaseerd op een pre-specified genomische clinical assay;
  • QoL.
Main eligibility criteria:
  • ER+ en/of PR+, HER2 negatef, invasieve borstkanker
  • Pre- en  postmenopauzaal
  • Stadium II (Stadium IIA gelimiteerd tot max.1000 patienten) of Stadium III
  • Vrouw of man
Documents (public):

Protocol synopsis

Documents (protected):
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