Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer

  • STATUS
    Recruiting
  • End date
    Sep 27, 2023
  • participants needed
    25
  • sponsor
    Centre Oscar Lambret
Updated on 27 January 2021

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.

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.

Details
Condition Advanced Breast Cancer
Treatment specimen sample collection
Clinical Study IdentifierNCT04653740
SponsorCentre Oscar Lambret
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Do you have Advanced Breast Cancer??
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)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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