NCT04653740

Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer

Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC): A Cohort Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a monocentric cohort study, prospective and interventional with minimal risks and constraints for advanced breast cancer. The planned interventions are collection of biological samples at different times. The study will aim to do a descriptive analysis of omics profiles evolution (tumor, volatile organic components) over time, before and after disease progression under Palbociclib treatment with a clinical-biological database.

Detailed description

Patients enrolled in the study will receive the following interventions: * Biospecimen sample collection: before and during treatment, and at progression * Tumor biopsy before treatment and at progression The aim of this study is to describe molecular changes associated with resistance to Palbociclib at the individual level and describe longitudinal changes in the profile of tumor, VOCs and exosomes according to treatment response. Other objectives of the study include: * Proportion of single or shared molecular alterations / signatures between patients at progression time * Associations between tumor signatures, VOCs and exosomes * Compare molecular changes identified by proteomics with those observed by genomics / transcriptomics * Compare the evolution of VOCs and exosomes over time with evolution of liquid biopsy markers.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	specimen sample collection	Before and during treatment, and at progression, collection of : * Blood * Exhaled air * Saliva * Sweat * Tears * Urine

Timeline

• Start date: 2020-09-08
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-12-04
• Last updated: 2026-03-17

Locations

1 site across 1 country: France