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Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

NCT02028364 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-08-24

No results posted yet for this study

Summary

This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive Everolimus 10mg orally daily given in conjunction with exemestane 25mg orally daily until disease progression or treatment discontinuation for any other reasons. The main objectives are to evaluate if early metabolic response (MR) using FDG-PET/CT is associated with progression free survival (PFS) and overall survival (OS) in this population.

Tumour, metastatic lesions and blood samples will be collected during the treatment period in order to identify biomarkers predicting resistance to study treatment. Results will be correlated with the results of early FDG PET/CT data in order to better characterise the non-responders.

Conditions

Interventions

DRUG

Everolimus

10mg orally daily

DRUG

Exemestane

25mg orally daily

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Andrea Gombos, MD · Insitut Jules Bordet

  • Patrick Flamen, MD · Jules Bordet Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-12
Primary Completion
2021-07-06
Completion
2021-08-09

Countries

  • Belgium

Study Locations

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Entities

Drugs
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 NCT02028364 on ClinicalTrials.gov