Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05861830
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-05-07
Brief Title:
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK46 Inhibitor Failure DAWNA-FES
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
An Exploratory Study on Predicting the Efficacy of Dalpiciclib in Combination With Endocrine Therapy for HR-Positive and HER2-Negative RecurrentMetastatic Breast Cancer Patients After CDK46 Inhibitor Treatment Failure Using 18F-FES PETCT
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
CDK46 inhibitors are currently the standard treatment for female breast cancer patients with HR tumors However there is no established standard treatment for patients who experience treatment failure with CDK46 inhibitors The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK46 inhibitors We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy following treatment failure with CDK46 inhibitors would similarly lead to improved patient survival In this study 18F-FES PETCT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients
Detailed Description:
With the emergence of targeted therapies the treatment landscape for patients with hormone receptor-positive HR and HER2-negative HER2- metastatic breast cancer MBC is continuously evolving The combination of cyclin-dependent kinases 4 and 6 inhibitors CDK46i with endocrine therapy has become the standard treatment approach for first-line therapy or treatment after progression on endocrine therapy Multiple large randomized studies have demonstrated that the combination of CDK46i and endocrine therapy significantly improves progression-free survival PFS in HRHER2- MBC patients Updated analyses have also shown a significant improvement in overall survival OS with the combination of endocrine therapy and either Palbociclib or Ribociclib Currently regulatory agencies have approved four CDK46 inhibitors namely Palbociclib Abemaciclib Ribociclib and Dalpiciclib for the treatment of HRHER2- breast cancer All four CDK46 inhibitors are approved for use in combination with endocrine therapy for advanced HRHER2- breast cancer Abemaciclib has also been approved for use as adjuvant therapy in early-stage breast cancer with HRHER2- subtype and high-risk recurrent factors as well as for the treatment of advanced breast cancer
CDK46 inhibitors are currently the standard treatment for female breast cancer patients with HR tumors However there is no established standard treatment for patients who experience treatment failure with CDK46 inhibitors Despite the extensive clinical experience with these drugs our understanding of the long-term effects of CDK46 blockade in patients previously treated with CDK46 inhibitors is limited The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK46 inhibitors We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy following treatment failure with CDK46 inhibitors would similarly lead to improved patient survival
18F-fluorodeoxyglucose FDG PET imaging is widely utilized in the field of oncology to detect increased glucose metabolism activity In the case of breast cancer 18F-FDG PETCT imaging is predominantly recommended for patients with unclear staging advanced disease or metastasis when conventional imaging methods are inconclusive On the other hand 18F-fluoroestradiol FES is an endogenous estrogen analogue that specifically binds to estrogen receptors ERs Through PET imaging FES enables dynamic quantitative and non-invasive assessment of ER expression levels and distribution within the patients body When combined with 18F-FDG PET or other imaging modalities 18F-FES PET imaging can evaluate the heterogeneity of ER expression and has the potential to identify ER loss or dysfunction It has been observed that 18F-FES PET exhibits good correlation with traditional immunohistochemistry for assessing ER expression Moreover published human studies have not reported any toxicity or adverse reactions associated with 18F-FES usage In this study 18F-FES PETCT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients
CDK46 inhibitors are currently the standard treatment for female breast cancer patients with HR tumors However there is no established standard treatment for patients who experience treatment failure with CDK46 inhibitors Despite the extensive clinical experience with these drugs our understanding of the long-term effects of CDK46 blockade in patients previously treated with CDK46 inhibitors is limited The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK46 inhibitors We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy following treatment failure with CDK46 inhibitors would similarly lead to improved patient survival
18F-fluorodeoxyglucose FDG PET imaging is widely utilized in the field of oncology to detect increased glucose metabolism activity In the case of breast cancer 18F-FDG PETCT imaging is predominantly recommended for patients with unclear staging advanced disease or metastasis when conventional imaging methods are inconclusive On the other hand 18F-fluoroestradiol FES is an endogenous estrogen analogue that specifically binds to estrogen receptors ERs Through PET imaging FES enables dynamic quantitative and non-invasive assessment of ER expression levels and distribution within the patients body When combined with 18F-FDG PET or other imaging modalities 18F-FES PET imaging can evaluate the heterogeneity of ER expression and has the potential to identify ER loss or dysfunction It has been observed that 18F-FES PET exhibits good correlation with traditional immunohistochemistry for assessing ER expression Moreover published human studies have not reported any toxicity or adverse reactions associated with 18F-FES usage In this study 18F-FES PETCT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients
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