Ignite Creation Date:
2024-05-05 @ 11:15 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01288092
Status:
WITHDRAWN
Last Update Posted:
2012-06-07
First Post:
2011-01-19
Brief Title:
BEZ235 Trial in Patients With HER2-Human Epidermal Growth Factor Receptor 2 Negative HR Hormonal Receptor Positive Metastatic Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Study of Orally Administered BEZ235 Monotherapy in Patients With Hormone Receptor Positive HER2 Negative Metastatic Breast Cancer With or Without PI3K Activated Pathway
Status:
WITHDRAWN
Status Verified Date:
2012-06
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:
None
Brief Summary:
This is a prospective multi-center open-label single arm phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease Patients will be stratified into 3 groups according to their PI3K phosphatidylinositol 3-Kinase pathway activation status
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 |
|---|---|---|---|
| 2010-024394-39 | EUDRACT_NUMBER | None | None |