Clinical trial NCT05303129: 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Metastatic Breast Cancer
Keywords: CDK4/6
lymphocyte typing
Neutrophil/Lymphocyte ratio (NLR)
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival rate
timeFrame: At 12 months after initiation of CDK 4/6 treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Rouen
country: France
facility: Centre Henri BECQUEREL
Study officials:
References: