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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Oscar Lambret

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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