Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365788
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-07-11
Brief Title:
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-07
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:
ABBICAR
Brief Summary:
This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer
Detailed Description:
This study is a phase II single arm clinical trial Phase II clinical trials test the safety and effectiveness of an intervention to learn whether the intervention works in treating a specific disease
In this study the investigators will include patients with locally advanced unresectable or metastatic androgen receptor positive triple negative breast cancer The participants need to be progressive after at least 1 prior cytostatic regimen in advanced setting
The participants will be treated with bicalutamide and abemaciclib Bicalutamide works against the androgen receptor and abemaciclib stops the cell cycle
The investigators will look into if this combination can help patients with androgen receptor positive triple negative breast cancer The investigators will also look into if this is a safe combination
In this study the investigators will include patients with locally advanced unresectable or metastatic androgen receptor positive triple negative breast cancer The participants need to be progressive after at least 1 prior cytostatic regimen in advanced setting
The participants will be treated with bicalutamide and abemaciclib Bicalutamide works against the androgen receptor and abemaciclib stops the cell cycle
The investigators will look into if this combination can help patients with androgen receptor positive triple negative breast cancer The investigators will also look into if this is a safe combination
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502272-23-00 | OTHER | EU CT Number | None |