Ignite Creation Date:
2024-05-06 @ 12:37 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01610284
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2012-05-11
Brief Title:
Phase III Study of BKM120Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
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 Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Status:
COMPLETED
Status Verified Date:
2020-08
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:
BELLE-2
Brief Summary:
This study was a multi-center randomized double-blind placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive HR-positive human epidermal growth factor receptor 2-negative HER2-negative locally advanced or metastatic breast cancer MBC whose disease has progressed on or after aromatase inhibitor AI treatment
Detailed Description:
Patients were randomized 11 to receive buparlisib 100 mgday or placebo with fulvestrant 500 mg randomization was stratified by PI3K pathway activation status activated non-activated unknown determined in archival tumor tissue and visceral disease status present or absent Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression based on Response Evaluation Criteria In Solid Tumors RECIST version 11
Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program Accordingly on 19-Dec-2016 Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer As a result the CBKM120F2302 study was terminated on 19-Apr-2019 last subject last visit
Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program Accordingly on 19-Dec-2016 Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer As a result the CBKM120F2302 study was terminated on 19-Apr-2019 last subject last visit
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 |
|---|---|---|---|
| 2011-005524-17 | EUDRACT_NUMBER | None | None |