Ignite Creation Date:
2024-05-06 @ 9:17 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02947685
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2016-10-26
Brief Title:
Randomized Open Label Clinical Study of the Targeted Therapy Palbociclib to Treat Metastatic Breast Cancer
Sponsor:
Alliance Foundation Trials LLC
Organization:
Alliance Foundation Trials LLC
Study Overview
Official Title:
A Randomized Open Label Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib Anti-HER2 Therapy Endocrine Therapy vs Anti-HER2 Therapy Endocrine Therapy After Induction Treatment for Hormone Receptor Positive HRHER2-Positive Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
PATINA
Brief Summary:
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive HER2 metastatic breast cancer
Detailed Description:
Subjects will be randomized into one of two treatment arms following minimum of 4 and maximum of 8 cycles of induction treatment with anti-HER2 therapy Arm A subjects will receive the experimental therapy palbociclib in addition to their current anti-HER2 therapy and endocrine therapy Arm B subjects will continue to receive the anti-HER2 therapy It is expected that the addition of palbociclib to the first-line treatment of HER2 disease will delay the onset of therapeutic resistance and ultimately prolong the survival of patients with metastatic breast cancer The study is designed to treat the subset of patients with HER2 disease who are also hormone receptor positive HR It is also expected that palbociclib will modulate the endocrine resistance in HER2HR disease and potentiate the benefits of anti-HER2 therapy Lastly the current study includes a comprehensive molecular characterization of the disease at study entrance which will allow us to investigate the benefits of palbociclib in subsets of HER2HR disease such as PIK3CA mutant
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