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 NCT02109913
METC approval Yes Date: 17-03-2014 METC: Nr: 2.013.406
Amendments No Date:
KWF-CKS approval No Date: Nr:
News item
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


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

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.

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