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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