Studieoverzicht - 2013-06 Biomarker Study Everolimus

 
Number 2013-06 Biomarker Study Everolimus
Nickname Biomarker Study Everolimus
Status Follow up 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) E. Boven (VUmc)
Study manager D. Kruger VUmc e-mail: d.kruger@vumc.nl
J. Rademaker-Lakhai (BOOG Study Center)
Central datamanagement and randomization D. Kruger VUmc e-mail: d.kruger@vumc.nl
Monitoring Not applicable

Local datamanagement D. Kruger VUmc e-mail: d.kruger@vumc.nl
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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