Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Palbociclib

Before and during treatment, and at progression, collection of :

* Blood
* Exhaled air
* Saliva
* Sweat
* Tears
* Urine

specimen sample collection

Nawale NH HAJJAJI, MD, PhD

Marie MV VANSEYMORTIER, MD, PhD

Nawale NH Hajjaji, MD, PhD

Charlotte CB Bellier, MD, PhD

Emilie EK Kaczmarek, MD, PhD

Audrey AM Maillez, MD, PhD

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.

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.

Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer

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

Concordance between identified proteins and expressed genes and/or detected mutations

Intra-patient variation over time in VOC rate (rate of CA15.3)

Intra-patient variation over time in exosomes count (rate of CA15.3)

Intra-patient variation over time in liquid biopsy markers (rate of CA15.3)

Intra-patient variation over time in VOC rate (rate of LDH)

Intra-patient variation over time in exosomes count (rate of LDH)

Intra-patient variation over time in liquid biopsy markers (rate of LDH)

Variation over time in the rate of VOCs in response to treatment and in progression situations.

variation over time in exosomes count in response to treatment and in progression situations

Frequency of molecular alterations in the population

Distribution of VOCs and exosome profiles according to the different molecular profiles of tumors that will be identified

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer	NCT04653740	Advanced Breast...	specimen sample...	18 Years -	Centre Oscar Lambret
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer	NCT04653740	Advanced Breast...	specimen sample...	18 Years -	Centre Oscar Lambret

Spots Global Cancer Trial Database for omics profiles