Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| specimen sample collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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)
- description
- Variation over time in the rate of VOCs in response to treatment and in progression situations.
- 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
- description
- variation over time in exosomes count in response to treatment and in progression situations
Secondary outcomes (2)
- measure
- Proportion of alterations / molecular signatures unique or shared between patients at progression
- timeFrame
- At progression time, up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available