Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01633060
Status:
TERMINATED
Last Update Posted:
2019-01-30
First Post:
2012-06-29
Brief Title:
A Phase III Study of BKM120 With Fulvestrant in Patients With HRHER2- AI Treated Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Randomized Double Blind Placebo Controlled Study of BKM120 With Fulvestrant in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Novartis decided not to pursue further development of buparlisib program assessment of moderate PFS benefit with know but manageable buparlisib profile
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BELLE-3
Brief Summary:
This study was a multicenter randomized double-blind placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive HR-positive human epidermal growth factor receptor 2-negative HER2-negative aromatase inhibitor AI-treated locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor mTORi-based treatment
Patients were randomized in 21 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg Randomization was stratified according to visceral disease status present or absent
Patients were randomized in 21 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg Randomization was stratified according to visceral disease status present or absent
Detailed Description:
Novartis decided not to pursue further development of buparlisib program On 19 Dec 2016 Novartis notified the Investigators about this decision accordingly the CBKM120F2303 study was terminated
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 |
|---|---|---|---|
| 2012-002571-34 | EUDRACT_NUMBER | None | None |