Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02437318
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2015-04-22
Brief Title:
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Randomized Double-blind Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
Status:
COMPLETED
Status Verified Date:
2023-11
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:
SOLAR-1
Brief Summary:
To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive HR HER2-negative advanced breast cancer who received prior treatment with an Aromatase Inhibitor either as neoadjuvant or for advanced disease
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 |
|---|---|---|---|
| 2015-000340-42 | EUDRACT_NUMBER | None | None |