Studieoverzicht - 2013-03 PERNETTA
| Number | 2013-03 PERNETTA | ||||
| Nickname | PERNETTA Trial | ||||
| Status | Closed | Date: 10-12-2020 | |||
| 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 | https://www.sakk.ch/en/news/sakk-presentations-esmo-breast-cancer-2019 | ||||
| Sponsor | SAKK | ||||
| Principal Investigator(s) | E. Boven (VUMC) | |||
| Study manager | E. van Leeuwen-Stok (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:
- OS at 24 months (secondary analysis, see protocol section 13.2)
- PFS of first-line treatment ignoring first brain lesion
- PFS of second-line treatment
- PFS of second-line treatment ignoring first brain lesion
- Time to failure of strategy (TFS) of first- plus second-line treatment
- OS
- Objective response (OR) of first-line treatment (based on investigator assessment)
- Disease control (DC) of first-line treatment (based on investigator assessment)
- OR of second-line treatment (based on investigator assessment)
- DC of second-line treatment (based on investigator assessment)
- Adverse events according to CTCAE v4.0 of first-line treatment
- Adverse events according to CTCAE v4.0 of second-line treatment
- Adverse events grade ≥2 until first progression (ignoring first brain lesion)
- Quality of Life (QoL)
- PFS of third-line treatment
- Further treatment lines (third-line etc.)
- Time to brain metastases
- Time from first brain metastases to death
Main eligibility criteria:
Documents (public):
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