Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer

Advanced Breast Cancer Clinical Trial

— OMERIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653740
• Other study ID #: OMERIC-1904
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: September 2023

Study information

• Verified date: September 2020
• Source: Centre Oscar Lambret
• Contact: Nawale NH HAJJAJI, MD, PhD
• Phone: 0320295910
• Email: promotion[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• specimen sample collection
Before and during treatment, and at progression, collection of : Blood Exhaled air Saliva Sweat Tears Urine

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Laboratoire PRISM - Michel SALZET

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concordance between molecular changes identified by proteomics and those observed by genomics/transcriptomics	Concordance between identified proteins and expressed genes and/or detected mutations	At progression time, up to 2 years
Other	Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)	Intra-patient variation over time in VOC rate (rate of CA15.3)	At progression time, up to 2 years
Other	Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)	Intra-patient variation over time in exosomes count (rate of CA15.3)	At progression time, up to 2 years
Other	Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)	Intra-patient variation over time in liquid biopsy markers (rate of CA15.3)	At progression time, up to 2 years
Other	Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)	Intra-patient variation over time in VOC rate (rate of LDH)	At progression time, up to 2 years
Other	Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)	Intra-patient variation over time in exosomes count (rate of LDH)	At progression time, up to 2 years
Other	Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)	Intra-patient variation over time in liquid biopsy markers (rate of LDH)	At progression time, up to 2 years
Primary	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)
Primary	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	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
Secondary	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