Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (NCT04653740) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
France25 participantsStarted 2020-09-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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