NCT05303129Completed
Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 Inhibitor.
Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 in
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied. We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer. We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients. Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 165 (actual)
- First submitted
- 21 Mar 2022
- Start date
- 27 May 2022
- Primary completion date
- 17 Dec 2024
- Lead sponsor
- Centre Francois Baclesse
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05303129
What you commit to
- Study type: Interventional
- Participants enrolled: 165
- From 27 May 2022 to the primary completion date, 17 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
Other illness
- Locally advanced or relapsed breast cancer for which curative treatment would be considered
Other
- Her2-positive tumor status on either the primary or relapsed tumor as defined by ASCO criteria
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.