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 | |||||
Website | http://pallastrial.org/ | ||||
Sponsor | Pfizer |
Principal Investigator(s) | NL: M. Los | |||
Study manager | ||||
Central datamanagement and randomization | ||||
Monitoring | ||||
Local datamanagement | ||||
Funding | Pfizer | |||
Extra | 2nd interim analysis May 2020; Final analysis Q4 2020 |
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
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