Status:
COMPLETED
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.
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Breast Cancer
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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. W...
Detailed Description
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. W...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2024
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT05303129
Start Date
May 27 2022
End Date
December 17 2024
Last Update
January 20 2025
Active Locations (2)
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1
Centre François Baclesse
Caen, France
2
Centre Henri BECQUEREL
Rouen, France