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Analysis of Tumor Tissue and Circulating Genetic Material in the Blood to Obtain Further Insight in the Effectiveness of Everolimus When Combined With Exemestane

NCT02109913 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2019-10-14

No results posted yet for this study

Summary

The purpose of this study is to determine whether biomarkers could be found to gain more insight in tumor characteristics in order to predict which patients will have a high chance of a long progression-free survival. Postmenopausal patients with advanced metastatic breast cancer who have progressed on anastrozole or letrozole will be eligible for this study.

Conditions

Interventions

DRUG

Everolimus plus Exemestane

Everolimus 10mg, oral, daily; exemestane 25 mg, oral, daily. Number of Cycles: until progression or unacceptable toxicity develops. From all patients, 4 additional blood samples, 6ml each, will be collected and an optional tumor biopsy will be taken, if eligible.

Sponsors & Collaborators

  • Borstkanker Onderzoek Groep

    collaborator NETWORK

  • Novartis

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Epie Boven, Prof.dr. MD · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109913 on ClinicalTrials.gov