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Biomarker Study Everolimus

  • Closed

BOOG 2013-06

General Information

BOOG number

BOOG 2013-06

Nickname

Biomarker Study Everolimus

Status

  • Closed
Date: 14/02/2017

Inclusion closed

14/02/2017

Full title

PI3K pathway analysis in tumor tissue and circulating DNA to obtain further insight in the efficacy of everolimus when combined with exemestane

Indication

  • Advanced/Metastatic

Subindication

HER2- HR+

Target sample size

175

Actual accrual

175
Date: 14/02/2017

Estimated study completion date

31/12/2016

Contact

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

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

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.

Regulatory Information

CCMO approval

Yes
Date: 17/11/2013
Nr: NL46195.029.13

EC approval

Yes
Date: 17/03/2014
Nr:2.013.406
Amendments:
No

EudraCT number

2013-004120-11

Trial Register

NTR4570 Clinicaltrails.gov NCT02109913

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