Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02632045
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2015-12-14
Brief Title:
Study of Efficacy of Ribociclib After Progression on CDK46 Inhibition in Patients With HR HER2- Advanced Breast Cancer
Sponsor:
Melissa K Accordino
Organization:
Columbia University
Study Overview
Official Title:
A randoMized phAse II trIal of fulvestraNt wiTh or Without Ribociclib After Progression on AntI-estrogeN Therapy Plus Cyclin-dependent Kinase 46 Inhibition in Patients With Unresectable or Metastatic Hormone Receptor HER2 - Breast Cancer MAINTAIN Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
MAINTAIN
Brief Summary:
This is a randomized trial for patients with metastatic hormone receptor HR-positive human epidermal growth factor receptor 2 HER2-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK46 inhibitor either palbociclib or ribociclib to either fulvestrant alone or fulvestrant with ribociclib LEE-011 The purpose of the trial is to determine whether there is continued benefit for patients to remain on a CDK46 inhibitor at the time of switching anti-estrogen therapy As ribociclib and palbociclib have a similar toxicity and drug profile and mechanism of action we feel that it is appropriate for patients to receive either drug with an aromatase inhibitor prior to randomization
Detailed Description:
Despite advances in early detection and therapeutic options unresectable or metastatic breast cancer remains incurable and is one of the leading causes of cancer-related mortality Breast cancer is a molecularly heterogeneous disease This study will be evaluating estrogen receptor ER expression positivity andor progesterone receptor PgR positivity of breast cancer with the absence of over-expression or amplification of HER2
Inhibitors of the cyclin dependent kinases 4 and 6 CDK46 have been developed and demonstrated impressive activity in patients with ER-positive HER2-negative breast cancer with marked improvements in progression free survival This question is asking whether CDK 46 inhibition should be continued with hormone therapy in patients who will be switching their hormone therapy in the metastatic breast cancer setting
Inhibitors of the cyclin dependent kinases 4 and 6 CDK46 have been developed and demonstrated impressive activity in patients with ER-positive HER2-negative breast cancer with marked improvements in progression free survival This question is asking whether CDK 46 inhibition should be continued with hormone therapy in patients who will be switching their hormone therapy in the metastatic breast cancer setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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