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 5795 (NL: 27) 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
Sponsor Pfizer
Principal Investigator(s) NL: M. Los
Study manager
Central datamanagement and randomization
Local datamanagement
Funding Pfizer
Extra 2nd interim analysis May 2020; Final analysis Q4 2020



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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