Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Advanced Breast Cancer

Intervention / Treatment
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* Procedure: specimen sample collection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: specimen sample collection|Before and during treatment, and at progression, collection of : Blood Exhaled air Saliva Sweat Tears Urine|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrapatient variation in molecular profiles at progression compared to baseline | 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 | 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 | Frequency of molecular alterations in the population | At progression time, up to 2 years | 
| Correlation between tumor signatures, VOCs and exosomes | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, omics profiles, proteomics, volatile organic compounds, exosomes