Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650748
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK46 Inhibitors in HRHER2- Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK46 Inhibitors in HRHER2- Breast Cancer a Randomize-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center randomize-controlled study The purpose of this study is to evaluate the efficacy of neoadjuvant CDK46 inhibitors in patients with high-risk EPclin multigene risk analysis and non-response to Ki-67 2W and to explore predictive biomarkers for sensitivity to CDK46 inhibitor therapy
Detailed Description:
China is a country with a high incidence of breast cancer For operable hormone receptor-positive HR human epidermal growth factor receptor 2-negative HER2- breast cancer traditional neoadjuvant chemotherapy often fails to achieve clinical complete response CCR and has poor tolerability Endocrine therapy plays a significant role in the treatment of advanced and early-stage HRHER2- breast cancer but its efficacy in neoadjuvant settings needs further exploration Studies have shown that the CCR and breast conservation rate of neoadjuvant endocrine therapy for HRHER2- breast cancer are similar to those of neoadjuvant chemotherapy with lower toxicity Therefore by precisely stratifying the recurrence risk of HRHER2- patients and treating them according to different risk levels the response rate to neoadjuvant endocrine therapy can be further improved which would be more beneficial for the patients With the clinical application of CDK46 inhibitors the effectiveness of neoadjuvant endocrine therapy is expected to be enhanced
In PALLET study the combination of palbociclib and letrozole significantly inhibited Ki-67 expression leading to a higher number of patients achieving a state of cell cycle arrest CCCA defined as Ki-6727 NeoMONARCH study suggests that a regimen containing abemaciclib is significantly superior to anastrozole monotherapy with statistical significance P 0001 The NeoPAL and CORALLEEN studies indicate that neoadjuvant endocrine therapy with palbociclib or ribociclib is comparable in efficacy to neoadjuvant chemotherapy yet has fewer side effects
EndoPredict 12-gene assay EPclin is a second-generation multigene testing scoring tool that combines the molecular biological status of the tumor with clinical factors tumor size and lymph node status For early-stage HRHER2- breast cancer patients the EPclin test result helps to distinguish between low and high recurrence risk populations allowing for a more precise assessment of patient prognosis In the validation study for premenopausal patients a total of 385 patients with stage pT3 and pN01 who received only endocrine therapy for ERHER2- early invasive breast cancer were enrolled The results showed that the 10-year distant recurrence-free survival DRFS rate for patients in the EPclin low-risk group reached 97 while the 10-year DRFS rate for the EPclin high-risk group was 76 P0004 For postmenopausal patients the prognostic value of EPclin was independently validated through the ABCSG68 study The study included 1702 patients with ERHER2- early invasive breast cancer who underwent surgery and received only five years of endocrine therapy The results showed that the 10-year distant recurrence rate for patients in the EPclin low-risk group was 4 while the 10-year distant recurrence rates for patients in the EPclin high-risk group were 28 and 22 P0001 A retrospective analysis of ABCSG-34 demonstrated that for patients undergoing neoadjuvant endocrine therapy the application of EPclin for prognostic assessment revealed a negative correlation between risk levels and residual cancer burden RCB That is among patients receiving neoadjuvant endocrine therapy NET a higher proportion of low-risk patients compared to high-risk patients ultimately had an RCB of 0-I
This study focuses on early-stage HRHER2- breast cancer conducting recurrence risk analysis through EPclin multigene testing and integrating the dynamic changes of Ki67 after two weeks of neoadjuvant endocrine therapy Patients are risk-stratified and treated with or without CDK46 inhibitors The study explores the improvement in PEPI scores after surgery and analyzes the effectiveness of multigene testing combined with Ki67 dynamic changes as a predictor for the efficacy of CDK46 inhibitor treatment in HRHER2- breast cancer with high recurrence risk and insensitivity to endocrine therapy The study also seeks to explore methods for predicting sensitivity to CDK46 inhibitor treatment
In PALLET study the combination of palbociclib and letrozole significantly inhibited Ki-67 expression leading to a higher number of patients achieving a state of cell cycle arrest CCCA defined as Ki-6727 NeoMONARCH study suggests that a regimen containing abemaciclib is significantly superior to anastrozole monotherapy with statistical significance P 0001 The NeoPAL and CORALLEEN studies indicate that neoadjuvant endocrine therapy with palbociclib or ribociclib is comparable in efficacy to neoadjuvant chemotherapy yet has fewer side effects
EndoPredict 12-gene assay EPclin is a second-generation multigene testing scoring tool that combines the molecular biological status of the tumor with clinical factors tumor size and lymph node status For early-stage HRHER2- breast cancer patients the EPclin test result helps to distinguish between low and high recurrence risk populations allowing for a more precise assessment of patient prognosis In the validation study for premenopausal patients a total of 385 patients with stage pT3 and pN01 who received only endocrine therapy for ERHER2- early invasive breast cancer were enrolled The results showed that the 10-year distant recurrence-free survival DRFS rate for patients in the EPclin low-risk group reached 97 while the 10-year DRFS rate for the EPclin high-risk group was 76 P0004 For postmenopausal patients the prognostic value of EPclin was independently validated through the ABCSG68 study The study included 1702 patients with ERHER2- early invasive breast cancer who underwent surgery and received only five years of endocrine therapy The results showed that the 10-year distant recurrence rate for patients in the EPclin low-risk group was 4 while the 10-year distant recurrence rates for patients in the EPclin high-risk group were 28 and 22 P0001 A retrospective analysis of ABCSG-34 demonstrated that for patients undergoing neoadjuvant endocrine therapy the application of EPclin for prognostic assessment revealed a negative correlation between risk levels and residual cancer burden RCB That is among patients receiving neoadjuvant endocrine therapy NET a higher proportion of low-risk patients compared to high-risk patients ultimately had an RCB of 0-I
This study focuses on early-stage HRHER2- breast cancer conducting recurrence risk analysis through EPclin multigene testing and integrating the dynamic changes of Ki67 after two weeks of neoadjuvant endocrine therapy Patients are risk-stratified and treated with or without CDK46 inhibitors The study explores the improvement in PEPI scores after surgery and analyzes the effectiveness of multigene testing combined with Ki67 dynamic changes as a predictor for the efficacy of CDK46 inhibitor treatment in HRHER2- breast cancer with high recurrence risk and insensitivity to endocrine therapy The study also seeks to explore methods for predicting sensitivity to CDK46 inhibitor treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None