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Blood test may predict breast cancer drug response

NCT ID NCT05303129

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 explored whether a simple blood test measuring the neutrophil-to-lymphocyte ratio (NLR) can help predict how well women with advanced breast cancer respond to a common treatment (CDK4/6 inhibitors plus hormone therapy). Researchers followed 165 patients starting this treatment for the first time. The goal was to see if a higher NLR before treatment was linked to faster disease progression.

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

165 people

The number who actually took part.

Started

May 2022

Finished

Dec 2024

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: * Patients with locally advanced or metastatic HR-positive, Her2-negative breast cancer * Patients who are scheduled to receive first-line metastatic CDK4/6 inhibitor therapy in combination with hormone therapy as per the marketing authorization * Patients who have not received previous anti-neoplastic therapies for metastatic or advanced disease (chemotherapy, targeted therapy or hormonal therapy). However, it will be possible to have initiated 1st line hormonal therapy within 4 to 6 weeks prior to inclusion. * Prior radiotherapy allowed even in metastatic disease. In case of radiotherapy treatment, side effects attributable to the treatment must be resolved. * Postmenopausal patients or patients with suppressed ovarian function * Patient with measurable or non-measurable disease (according to RECIST v1.1 criteria) * Adequate organ and marrow function to allow prescription of CDK 4/6 inhibitor therapy * Age of Patient ≥ 18 years * Willingness and ability to comply with scheduled visits, treatment plan, biologic tests and other trial procedures including assessments requested for inclusion * Patient affiliated with a social security plan * Informed consent signed prior to any specific study-related procedures Exclusion Criteria: * Men (no marketing authorization for CDK4/6 inhibitors in men in France) * Previous systemic treatment for metastatic disease (chemotherapy, hormone therapy, etc.) * Previous treatment with a CDK4/6 inhibitor (adjuvant or for metastatic disease) * Locally advanced or relapsed breast cancer for which curative treatment would be considered * Her2-positive tumor status on either the primary or relapsed tumor as defined by ASCO criteria * Patient with advanced, symptomatic visceral extension who may be at risk for a potentially fatal short-term complication ("visceral crisis") and who requires treatment with chemotherapy * Patients who are deprived of their liberty, under guardianship, or subject to a legal protection measure or who are unable to express their consent * Patients who cannot undergo the trial follow-up for geographical, social or psychopathological reasons

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centre François Baclesse

    Caen, France

  • Centre Henri BECQUEREL

    Rouen, France

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