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Breast cancer study to track Real-World use of newer pills

NCT ID NCT07443774

Knowledge-focused Sponsor: University Hospital, Grenoble 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 81 people with early-stage, hormone-positive breast cancer who are at high risk of the cancer coming back. Researchers want to see how often patients take their prescribed CDK4/6 inhibitor pills (abemaciclib or ribociclib) alongside standard hormone therapy. The goal is to understand real-world adherence and why some patients stop treatment early.

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.

Participants

About 81 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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.

Who is studied

Patients will be selected from those with localized, high-risk, hormone receptor-positive, HER2-negative breast cancer who are treated at one of the two participating centers and receive adjuvant therapy between 2023 and 2028, and who are eligible for treatment with CDK4/6 inhibitors. Patients will be seen in dedicated consultations, according to international recommendations, at least every six months, to assess treatment adherence, tolerability, and risk of recurrence. Recruitment will therefore take place directly during these consultations. All patients for whom an indication for iCDK4/6 therapy is established will be eligible to participate in the study. This indication is determined during multidisciplinary tumor board meetings, which are standard practice in the patient care pathway. The end of the inclusion period has been arbitrarily set five years later, in order to obtain a sufficient number of patients.

Ages

18 years and older

Sex

Anyone

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 * Male or female patients aged ≥18 years. * Operable invasive breast carcinoma of no special type, hormone receptor-positive / HER2-negative (estrogen receptor expression \>10% with or without progesterone receptor expression \>10%; HER2-negative defined as score 0, 1+, or 2+ non-amplified). * M0 disease according to the TNM 2018 classification. * Having undergone curative surgery of the primary breast tumor. * Having received adjuvant radiotherapy, if indicated. * Indication for combined adjuvant endocrine therapy and iCDK4/6 therapy validated during a multidisciplinary tumor board meeting. * Initiation of adjuvant endocrine therapy combined with a CDK4/6 inhibitor between June 2023 and June 2028. * No objection to participation in the study. * Affiliation with the national health insurance system. Non-Inclusion Criteria * Medical, geographical, sociological, psychological, or legal conditions that could prevent the patient from completing the study or from providing informed non-opposition. * Locally advanced, non-operable disease or metastatic disease not amenable to curative-intent treatment

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Abemaciclib Breast cancer Early breast cancer Endocrine therapy ER+ breast cancer Ribociclib

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Grenoble Alpes

    Grenoble, 38043, France

More trials for these conditions

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