Breast Cancer, Metastatic Breast Cancer
Conditions
Keywords
CDK4/6, lymphocyte typing, Neutrophil/Lymphocyte ratio (NLR)
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.
Interventions
BIOLOGICALBlood sampling
Blood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )
Sponsors
Centre Francois Baclesse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival Rate | At 12 months after initiation of CDK 4/6 treatment | Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53 |
Countries
France
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66 years |
| CDK 4/6 treatment type Abemaciclib | 53 Participants |
| CDK 4/6 treatment type Palbociclib | 23 Participants |
| CDK 4/6 treatment type Ribociclib | 87 Participants |
| Sex: Female, Male Female | 163 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 165 |
| other Total, other adverse events | 159 / 165 |
| serious Total, serious adverse events | 0 / 165 |
Outcome results
None listed