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NCT Number: NCT04653740

Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer

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.

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Key information

Conditions

Advanced Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, France, 59020

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

specimen sample collection

Procedure

Before and during treatment, and at progression, collection of :

  • Blood
  • Exhaled air
  • Saliva
  • Sweat
  • Tears
  • Urine

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Laboratoire PRISM - Michel SALZET

Registry information

Official study title

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

Acronym: OMERIC

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2020
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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