Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC)

March 16, 2026 updated by: Centre Oscar Lambret

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France
      • Lille, France, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women over 18 years old
  • With histologically proven breast cancer, positives hormones receptors and negative HER2
  • Advanced disease (metastases or non-resequable locoregional disease), from the 1st to the 4th line.
  • With an indication for hormone therapy associated with the CDK4/6 inhibitor Palbociclib
  • Agree to the sampling of the study
  • Signed the informed consent form

Exclusion Criteria:

  • Neoadjuvant or adjuvant treatment for localized breast cancer
  • Metastatic breast cancer beyond the forth line
  • Impossibility to give informed consent (person deprived of liberty or under guardianship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrapatient variation in molecular profiles at progression compared to baseline
Time Frame: From date of inclusion until the date of first documented progression (around 2 years)
Variation over time in the rate of VOCs in response to treatment and in progression situations.
From date of inclusion until the date of first documented progression (around 2 years)
longitudinal changes in VOCs profile and exosomes according to response to treatment
Time Frame: From date of inclusion until the date of first documented progression, assessed up to 2 years
variation over time in exosomes count in response to treatment and in progression situations
From date of inclusion until the date of first documented progression, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of alterations / molecular signatures unique or shared between patients at progression
Time Frame: At progression time, up to 2 years
Frequency of molecular alterations in the population
At progression time, up to 2 years
Correlation between tumor signatures, VOCs and exosomes
Time Frame: At progression time, up to 2 years
Distribution of VOCs and exosome profiles according to the different molecular profiles of tumors that will be identified
At progression time, up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between molecular changes identified by proteomics and those observed by genomics/transcriptomics
Time Frame: At progression time, up to 2 years
Concordance between identified proteins and expressed genes and/or detected mutations
At progression time, up to 2 years
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
Time Frame: At progression time, up to 2 years
Intra-patient variation over time in VOC rate (rate of CA15.3)
At progression time, up to 2 years
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
Time Frame: At progression time, up to 2 years
Intra-patient variation over time in exosomes count (rate of CA15.3)
At progression time, up to 2 years
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
Time Frame: At progression time, up to 2 years
Intra-patient variation over time in liquid biopsy markers (rate of CA15.3)
At progression time, up to 2 years
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
Time Frame: At progression time, up to 2 years
Intra-patient variation over time in VOC rate (rate of LDH)
At progression time, up to 2 years
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
Time Frame: At progression time, up to 2 years
Intra-patient variation over time in exosomes count (rate of LDH)
At progression time, up to 2 years
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
Time Frame: At progression time, up to 2 years
Intra-patient variation over time in liquid biopsy markers (rate of LDH)
At progression time, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Laboratoire PRISM - Michel SALZET

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMERIC-1904
  • 2019-A02235-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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