Advanced Breast Cancer
Conditions
Keywords
breast cancer, omics profiles, proteomics, volatile organic compounds, exosomes
Brief 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.
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.
Interventions
PROCEDUREspecimen sample collection
Before and during treatment, and at progression, collection of : * Blood * Exhaled air * Saliva * Sweat * Tears * Urine
Sponsors
Centre Oscar Lambret
Laboratoire PRISM - Michel SALZET
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrapatient variation in molecular profiles at progression compared to baseline | 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. |
| longitudinal changes in VOCs profile and exosomes according to response to treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of alterations / molecular signatures unique or shared between patients at progression | At progression time, up to 2 years | Frequency of molecular alterations in the population |
| Correlation between tumor signatures, VOCs and exosomes | 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 |
Countries
France
Outcome results
None listed