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 |
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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):
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