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PALLAS

  • Follow up

BOOG 2016-02

General Information

BOOG number

BOOG 2016-02

Nickname

PALLAS

Status

  • Follow up
Date: 30/11/2018

Inclusion closed

30/11/2018

Participating parties / group

ABCSG, BIG

Other study number

ABCSG 42, BIG 14-03

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

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

Contact

Sponsor

Pfizer

Principal Investigator(s)

NL: M. Los

Funding

Pfizer

Other

2nd interim analysis May 2020; Final analysis Q4 2020

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.

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

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 14/12/2016

EudraCT number

2014-005181-30

Trial Register

NCT02513394

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