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Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC)

Primary Purpose

Advanced Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
specimen sample collection
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Advanced Breast Cancer focused on measuring breast cancer, omics profiles, proteomics, volatile organic compounds, exosomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre Oscar LambretRecruiting

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Proportion of alterations / molecular signatures unique or shared between patients at progression
Frequency of molecular alterations in the population
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

Full Information

First Posted
September 15, 2020
Last Updated
November 27, 2020
Sponsor
Centre Oscar Lambret
Collaborators
Laboratoire PRISM - Michel SALZET
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1. Study Identification

Unique Protocol Identification Number
NCT04653740
Brief Title
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
Acronym
OMERIC
Official Title
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC): A Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Laboratoire PRISM - Michel SALZET

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
Keywords
breast cancer, omics profiles, proteomics, volatile organic compounds, exosomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
specimen sample collection
Intervention Description
Before and during treatment, and at progression, collection of : Blood Exhaled air Saliva Sweat Tears Urine
Primary Outcome Measure Information:
Title
Intrapatient variation in molecular profiles at progression compared to baseline
Description
Variation over time in the rate of VOCs in response to treatment and in progression situations.
Time Frame
From date of inclusion until the date of first documented progression (around 2 years)
Title
longitudinal changes in VOCs profile and exosomes according to response to treatment
Description
variation over time in exosomes count in response to treatment and in progression situations
Time Frame
From date of inclusion until the date of first documented progression, assessed up to 2 years
Secondary Outcome Measure Information:
Title
Proportion of alterations / molecular signatures unique or shared between patients at progression
Description
Frequency of molecular alterations in the population
Time Frame
At progression time, up to 2 years
Title
Correlation between tumor signatures, VOCs and exosomes
Description
Distribution of VOCs and exosome profiles according to the different molecular profiles of tumors that will be identified
Time Frame
At progression time, up to 2 years
Other Pre-specified Outcome Measures:
Title
Concordance between molecular changes identified by proteomics and those observed by genomics/transcriptomics
Description
Concordance between identified proteins and expressed genes and/or detected mutations
Time Frame
At progression time, up to 2 years
Title
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
Description
Intra-patient variation over time in VOC rate (rate of CA15.3)
Time Frame
At progression time, up to 2 years
Title
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
Description
Intra-patient variation over time in exosomes count (rate of CA15.3)
Time Frame
At progression time, up to 2 years
Title
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (CA15.3)
Description
Intra-patient variation over time in liquid biopsy markers (rate of CA15.3)
Time Frame
At progression time, up to 2 years
Title
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
Description
Intra-patient variation over time in VOC rate (rate of LDH)
Time Frame
At progression time, up to 2 years
Title
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
Description
Intra-patient variation over time in exosomes count (rate of LDH)
Time Frame
At progression time, up to 2 years
Title
Describe the evolution of VOCs and exosomes over time in relation to the evolution of liquid biopsy markers (LDH)
Description
Intra-patient variation over time in liquid biopsy markers (rate of LDH)
Time Frame
At progression time, up to 2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female with breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nawale NH HAJJAJI, MD, PhD
Phone
0320295910
Email
promotion@o-lambret.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie MV VANSEYMORTIER, MD, PhD
Phone
0320295910
Email
promotion@o-lambret.fr
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nawale NH HAJJAJI, MD, PhD
Phone
0320295910
Email
promotion@o-lambret.fr
First Name & Middle Initial & Last Name & Degree
Nawale NH Hajjaji, MD, PhD
First Name & Middle Initial & Last Name & Degree
Charlotte CB Bellier, MD, PhD
First Name & Middle Initial & Last Name & Degree
Emilie EK Kaczmarek, MD, PhD
First Name & Middle Initial & Last Name & Degree
Audrey AM Maillez, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer

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