Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03337724
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2017-11-07
Brief Title:
A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CAAKT1PTEN-Altered Locally Advanced or Metastatic Triple-Negative Breast Cancer or Hormone Receptor-Positive HER2-Negative Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CAAKT1PTEN-Altered Locally Advanced or Metastatic Triple-Negative Breast Cancer or Hormone Receptor-Positive HER2-Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
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:
IPATunity130
Brief Summary:
This study will evaluate the efficacy of ipatasertib paclitaxel versus placebo paclitaxel in participants with histologically confirmed locally advanced or metastatic triple-negative breast cancer TNBC and in participants with locally advanced or metastatic hormone receptor positive HR human epidermal growth factor receptor 2 negative HER2- breast adenocarcinoma who are not suitable for 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 |
|---|---|---|---|
| 2017-001548-36 | EUDRACT_NUMBER | None | None |