Ignite Creation Date:
2024-05-06 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05303129
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2022-03-21
Brief Title:
Prognostic Impact of the NeutrophilLymphocyte Ratio NLR in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK46 Inhibitor
Sponsor:
Centre Francois Baclesse
Organization:
Centre Francois Baclesse
Study Overview
Official Title:
Prognostic Impact of the NeutrophilLymphocyte Ratio NLR in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK46 in
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEPSI
Brief Summary:
The impact of the inflammatory microenvironment in predicting the benefit of a CDK46 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 CDK46 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 CDK46 inhibitor therapy in combination with hormone therapy in these patients
Specific blood tests lymphocyte typing will be performed during treatment with CDK46
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 CDK46 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 CDK46 inhibitor therapy in combination with hormone therapy in these patients
Specific blood tests lymphocyte typing will be performed during treatment with CDK46
Detailed Description:
The impact of the inflammatory microenvironment in predicting the benefit of a CDK46 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 CDK46 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 CDK46 inhibitor therapy in combination with hormone therapy in these patients
Specific blood tests lymphocyte typing will be performed during treatment with CDK46
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 CDK46 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 CDK46 inhibitor therapy in combination with hormone therapy in these patients
Specific blood tests lymphocyte typing will be performed during treatment with CDK46
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None