Studieoverzicht - 2013-06 Biomarker Study Everolimus
| Number | 2013-06 Biomarker Study Everolimus | ||||
| Nickname | Biomarker Study Everolimus | ||||
| Status | Closed | Date: 14-02-2017 | |||
| Inclusion closed | 14-02-2017 | ||||
| Other study number(s) | |||||
| Participating parties/groups | |||||
| Full title | PI3K pathway analysis in tumor tissue and circulating DNA to obtain further insight in the efficacy of everolimus when combined with exemestane | ||||
| Phase and type | Biomarker | ||||
| Age | ≥18 | ||||
| Menopausal status | Postmenopausal | ||||
| Indication | Advanced/metastatic | ||||
| Subindication | HER2- HR+ | ||||
| Target sample size | 175 | ||||
| Actual accrual | 175 | Date: 14-02-2017 | |||
| Estimated study completion date | 31-12-2016 | ||||
| CCMO approval | Yes | Date: 17-11-2013 | Nr: NL46195.029.13 | ||
| EudraCT nr. | 2013-004120-11 | ||||
| Trial Register | NTR4570 Clinicaltrails.gov NCT02109913 | ||||
| METC approval | Yes | Date: 17-03-2014 | METC: | Nr: 2.013.406 | |
| Amendments | No | Date: | |||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | VUmc | ||||
| Principal Investigator(s) | Prof. dr. Epie Boven (VUmc) | |||
| Study manager | A.E. van Leeuwen-Stok (BOOG Study Center) | |||
| Central datamanagement and randomization | VUmc | |||
| Monitoring | Not applicable |
|||
| Local datamanagement | VUmc | |||
| Funding | ||||
| Extra | ||||
Design:
Objectives:
In this side-study proposal we plan to gain more insight in tumor characteristics in order to predict which patients will have a high chance of a long progression-free survival
Endpoints:
Main eligibility criteria:
This side-study will be performed in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer whose disease is refractory to non-steroidal aromatase inhibitors (NSAI) and have a documented recurrence or progression on last therapy for breast cancer and will be treated with everolimus and exemestane.
Documents (public):
Back