Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369285
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-12
Brief Title:
A Study of Alisertib in Combination with Endocrine Therapy in Patients with HR-positive HER2-negative Recurrent or Metastatic Breast Cancer
Sponsor:
Puma Biotechnology Inc
Organization:
Puma Biotechnology Inc
Study Overview
Official Title:
A Phase 2 Study of Alisertib in Combination with Endocrine Therapy in Patients with HR HER2-negative Recurrent or Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ALISCA-Breast1
Brief Summary:
PUMA-ALI-1201 is a randomized dose optimization multicenter Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positiveHER2-negative metastatic breast cancer MBC following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy The study is also planned to evaluate the efficacy safety and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroups that may benefit most from combined alisertib and endocrine therapy
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511497-79-00 | CTIS | None | None |