Clinical trial NCT04653740: Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
Official title: Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC): A Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Advanced Breast Cancer
Keywords: breast cancer
omics profiles
proteomics
volatile organic compounds
exosomes
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Laboratoire PRISM - Michel SALZET
First posted: 2020-12-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intrapatient variation in molecular profiles at progression compared to baseline
timeFrame: From date of inclusion until the date of first documented progression (around 2 years)
measure: longitudinal changes in VOCs profile and exosomes according to response to treatment
timeFrame: From date of inclusion until the date of first documented progression, assessed up to 2 years
Secondary outcomes:
measure: Proportion of alterations / molecular signatures unique or shared between patients at progression
timeFrame: At progression time, up to 2 years
measure: Correlation between tumor signatures, VOCs and exosomes
timeFrame: At progression time, up to 2 years
Other outcomes:
measure: Concordance between molecular changes identified by proteomics and those observed by genomics/transcriptomics
timeFrame: At progression time, up to 2 years
measure: Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
timeFrame: At progression time, up to 2 years
measure: Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
timeFrame: At progression time, up to 2 years
measure: Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
timeFrame: At progression time, up to 2 years
measure: Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
timeFrame: At progression time, up to 2 years
measure: Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
timeFrame: At progression time, up to 2 years
measure: Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
timeFrame: At progression time, up to 2 years
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
References: