Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
NCT ID: NCT04653740
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
25 participants
INTERVENTIONAL
2020-09-08
2025-09-30
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Interventions
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specimen sample collection
Before and during treatment, and at progression, collection of :
* Blood
* Exhaled air
* Saliva
* Sweat
* Tears
* Urine
Eligibility Criteria
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Inclusion Criteria
* 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
* Metastatic breast cancer beyond the forth line
* Impossibility to give informed consent (person deprived of liberty or under guardianship)
18 Years
FEMALE
No
Sponsors
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Laboratoire PRISM - Michel SALZET
UNKNOWN
Centre Oscar Lambret
OTHER
Responsible Party
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Locations
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Centre Oscar Lambret
Lille, , France
Countries
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Other Identifiers
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OMERIC-1904
Identifier Type: -
Identifier Source: org_study_id