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PERNETTA Trial

  • Closed

BOOG 2013-03

General Information

BOOG number

BOOG 2013-03

Nickname

PERNETTA Trial

Status

  • Closed
Date: 10/12/2020

Inclusion closed

21/01/2016

Participating parties / group

SAKK / UNICANCER

Other study number

SAKK 22/10 / UNICANCER UC-0140/1207

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

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

Contact

Sponsor

SAKK

Principal Investigator(s)

E. Boven (VUMC)

Study manager

E. van Leeuwen-Stok (BOOG Study Center)

Central datamanagement and randomization

SAKK

Monitoring

IKNL

Other

https://www.sakk.ch/en/news/sakk-presentations-esmo-breast-cancer-2019

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

Regulatory Information

CCMO approval

Yes
Date: 24/02/2014
Nr: NL46227.029.13

EC approval

Yes
Date: 27/06/2014
Nr:2014.055

EC

Vrije Universiteit Medisch Centrum

EudraCT number

2012-002556-17

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