Advanced Breast CancerOMERICNCT04653740
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
A study testing specimen sample collection in people with Advanced Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- specimen sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2020to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC): A Cohort Study
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.
Read the 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.
- Conditions
- Advanced Breast Cancer
- Being tested
- specimen sample collection
- Keywords
- breast cancer, omics profiles, proteomics, volatile organic compounds, exosomes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specimen sample collectionProcedure or surgery
Before and during treatment, and at progression, collection of :
- Blood
- Exhaled air
- Saliva
- Sweat
- Tears
- Urine
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of inclusion until the date of first documented progression (around 2 years)
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
Measured: From date of inclusion until the date of first documented progression, assessed up to 2 years
Secondary outcomes (2)
Proportion of alterations / molecular signatures unique or shared between patients at progression
Frequency of molecular alterations in the population
Measured: At progression time, up to 2 years
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
Measured: At progression time, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start8 Sep 2020
- Primary completionOct 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire PRISM - Michel SALZET
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653740
- Sponsor's protocol ID
- OMERIC-1904
- Other IDs
- 2019-A02235-52
- Acronym
- OMERIC
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC): A Cohort Study
- ClinicalTrials.gov ID
- NCT04653740
- Acronym / sponsor ID
- OMERIC / OMERIC-1904
- Conditions
- Advanced Breast Cancer
- Keywords
- breast cancer, omics profiles, proteomics, volatile organic compounds, exosomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Laboratoire PRISM - Michel SALZET
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specimen sample collectionBefore and during treatment, and at progression, collection of : * Blood * Exhaled air * Saliva * Sweat * Tears * Urine | Procedure or surgery | – |
Primary outcome
Intrapatient variation in molecular profiles at progression compared to baseline
Time frame: 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
Time frame: 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
2 secondary outcomes
Proportion of alterations / molecular signatures unique or shared between patients at progression
Time frame: At progression time, up to 2 years
Correlation between tumor signatures, VOCs and exosomes
Time frame: At progression time, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specimen sample collection in people with Advanced Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapatient variation in molecular profiles at progression compared to baseline (time frame: From date of inclusion until the date of first documented progression (around 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.