Studieoverzicht - 2013-03 PERNETTA

 
Number 2013-03 PERNETTA
Nickname PERNETTA Trial
Status Follow up Date: 21-01-2016
Inclusion closed 21-01-2016
Other study number(s) SAKK 22/10 / UNICANCER UC-0140/1207
Participating parties/groups SAKK / UNICANCER
Full title A randomized phase II trial of pertuzumab incombination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer
Phase and type Randomized Phase II
Age ≥18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2+, any HR
Target sample size 208
Actual accrual 210 (NL 13) Date: 01-03-2016
Estimated study completion date 01-06-2015
CCMO approval Yes Date: 24-02-2014 Nr: NL46227.029.13
EudraCT nr. 2012-002556-17
Trial Register
METC approval Yes Date: 27-06-2014 METC: Vrije Universiteit Medisch Centrum Nr: 2014.055
Amendments Date:
KWF-CKS approval No Date: Nr:
News item
Website http://www.boogstudycenter.nl
Sponsor SAKK
Principal Investigator(s) E. Boven (VUMC)
Study manager J. Rademaker-Lakhai (BOOG Study Center)
Central datamanagement and randomization SAKK
Monitoring IKNL
Local datamanagement
Funding
Extra

Design:

 

Objectives:

The primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inhibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line) and of a chemotherapy-containing dual HER2-inhibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second line) in patients with HER2-positive metastatic breast cancer.

Secondary objectives are:

  • To evaluate other efficacy parameters
  • To evaluate the safety and tolerability profile of the two treatment strategies
  • To evaluate the Quality of Life (QoL)
  • To learn how patients are treated after trial treatment
Endpoints:

Primary endpoints: Overall survival (OS) at 24 months

Secondary endpoints:

  1. OS at 24 months (secondary analysis, see protocol section 13.2)
  2. PFS of first-line treatment ignoring first brain lesion
  3. PFS of second-line treatment
  4. PFS of second-line treatment ignoring first brain lesion
  5. Time to failure of strategy (TFS) of first- plus second-line treatment
  6. OS
  7. Objective response (OR) of first-line treatment (based on investigator assessment)
  8. Disease control (DC) of first-line treatment (based on investigator assessment)
  9. OR of second-line treatment (based on investigator assessment)
  10. DC of second-line treatment (based on investigator assessment)
  11. Adverse events according to CTCAE v4.0 of first-line treatment
  12. Adverse events according to CTCAE v4.0 of second-line treatment
  13. Adverse events grade ≥2 until first progression (ignoring first brain lesion)
  14. Quality of Life (QoL)
  15. PFS of third-line treatment
  16. Further treatment lines (third-line etc.)
  17. Time to brain metastases
  18. Time from first brain metastases to death
Main eligibility criteria:
Documents (public):
Documents (protected):
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