Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02831530
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-07-11
Brief Title:
Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib LY2835219 in Early Breast Cancer Patients
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib LY2835219 in Early Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2018-03
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:
ABC-POP
Brief Summary:
Cyclins CDK4 6 are extensively involved in the proliferation and growth of numerous cancers including breast cancer The objective of this study is to identify if a new preoperative oral treatment abemaciclib directed against the CDK 6 compared to no treatment inhibits tumor growth or induced senescence aging tumor
This early study is offered to women who are going to be operated on for breast cancer with expression of hormone receptor ER and or PR These women will have 3 chances to receive one for up to 14 days in the waiting period of their surgery abemaciclib as tablets Other patients do not receive treatment The decision to receive or no treatment will be done by a random computer draw
The drugs effectiveness will be evaluated primarily on the biological parameters of the tumor itself when comparing surgery to before treatment These results biomarkers will allow us to better know how this treatment and eventually will be used in future to identify patients for whom treatment with abemaciclib more efficiency
Patients treated in the protocol will then receive treatment entirely conventional in their breast cancer within the parameters of their tumors their participation is very limited in time
This early study is offered to women who are going to be operated on for breast cancer with expression of hormone receptor ER and or PR These women will have 3 chances to receive one for up to 14 days in the waiting period of their surgery abemaciclib as tablets Other patients do not receive treatment The decision to receive or no treatment will be done by a random computer draw
The drugs effectiveness will be evaluated primarily on the biological parameters of the tumor itself when comparing surgery to before treatment These results biomarkers will allow us to better know how this treatment and eventually will be used in future to identify patients for whom treatment with abemaciclib more efficiency
Patients treated in the protocol will then receive treatment entirely conventional in their breast cancer within the parameters of their tumors their participation is very limited in time
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20152288 | OTHER | CSET Number | None |