Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03538171
Status:
UNKNOWN
Last Update Posted:
2021-07-09
First Post:
2018-04-27
Brief Title:
Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
Sponsor:
Taizhou EOC Pharma Co Ltd
Organization:
Taizhou EOC Pharma Co Ltd
Study Overview
Official Title:
A Randomized Phase III Clinical Study of EntinostatPlacebo in Combination With Exemestane in Chinese Patients With Hormone Receptor-positive Advanced Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this randomized phase III trial is to evaluate the clinical benefit of combining entinostat with exemestane in Chinese patients with HR-positive HER2-negative locally advanced or metastatic breast cancer who have disease progression on endocrine therapy Additionallythe safety tolerability and PK profile of the treatment combination are evaluated
Detailed Description:
This randomized phase III trial studies entinostat combination with exemestane to see how well they work compared to exemestane alone in treating Chinese patients with hormone receptor-positive locally advanced or metastatic breast cancers
Estrogen can drive the growth of breast cancer cells Exemestane may fight breast cancer by lowering the amount of estrogen the body makes from tissue aromatase Entinostat may enhance the anti-tumor effect of exemestane in breast cancer by helping to overcome tumor resistance via epigenetic modifications Previous Phase II trial in US breast cancer patients have demonstrated significant effects of combined therapy in slowing disease progression and on patient survival when compared to exemestane alone It is not yet known whether exemestane is more effective when combined with entinostat in Chinese patients with advanced breast cancer In this parallel randomized double blind active controlled study we will study the effect of entinostatplacebo in combination with exemestane in Chinese patients with hormone receptor-positive HER2 receptor-negative locally advance or metastatic breast cancer who have experienced disease progression with prior endocrine therapies
Estrogen can drive the growth of breast cancer cells Exemestane may fight breast cancer by lowering the amount of estrogen the body makes from tissue aromatase Entinostat may enhance the anti-tumor effect of exemestane in breast cancer by helping to overcome tumor resistance via epigenetic modifications Previous Phase II trial in US breast cancer patients have demonstrated significant effects of combined therapy in slowing disease progression and on patient survival when compared to exemestane alone It is not yet known whether exemestane is more effective when combined with entinostat in Chinese patients with advanced breast cancer In this parallel randomized double blind active controlled study we will study the effect of entinostatplacebo in combination with exemestane in Chinese patients with hormone receptor-positive HER2 receptor-negative locally advance or metastatic breast cancer who have experienced disease progression with prior endocrine therapies
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