Blood test may predict breast cancer drug response
NCT ID NCT05303129
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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165 people
The number who actually took part.
- Started
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May 2022
- Finished
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Dec 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Centre François Baclesse
Caen, France
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Centre Henri BECQUEREL
Rouen, France
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Other studies related to the condition(s) this trial covers.
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