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Scientists hunt for genetic signs that show which breast cancer patients will benefit from kisqali

NCT ID NCT05529862

Knowledge-focused Sponsor: Institut Paoli-Calmettes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study collects tumor and blood samples from 241 women with HR+/HER2- advanced breast cancer before and after treatment with ribociclib (Kisqali) plus hormone therapy. Researchers will analyze DNA and RNA changes to find markers that predict who responds well and who develops resistance. The goal is to better understand why some patients benefit while others relapse, and to identify new drug targets for future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ribociclib (Kisqali) plus endocrine therapy
What this could lead to
If successful, this could help doctors predict which patients will benefit from ribociclib and endocrine therapy, and identify new treatment targets for those who don't respond.
What could go wrong
This is an observational, biomarker-focused study, not a treatment trial. It may not lead to immediate changes in patient care, and the findings might not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

115 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients included in the RosaLEE study. 2. Patients having read and signed the ICF relative to Trans-RosaLEE. 3. Tumour material: primary and/or metastatic tumour sample, either available as frozen and collected within 3 months before V0, or newly collected before ribociclib + ET treatment initiation. Brain metastases and non-osteolytic bone metastases will be considered as non-collectable/biopsable. 4. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen. Exclusion Criteria: 1. Not enrolled in RosaLEE. 2. Brain metastasis and non-osteolytic bone metastases as only metastatic sites, if no available frozen tumour sample already collected within 3 months before V0. 3. Tumour material not collected before ribociclib + ET initiation. 4. Person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to give their consent.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic breast cancer (BC)

Contacts and locations

Locations

  • Institut Paoli Calmettes

    Marseille, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.