Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01942135
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2013-09-10
Brief Title:
Palbociclib PD-0332991 Combined With Fulvestrant In Hormone Receptor HER2-Negative Metastatic Breast Cancer After Endocrine Failure PALOMA-3
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
MULTICENTER RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 3 TRIAL OF FULVESTRANT FASLODEX REGISTERED WITH OR WITHOUT PD-0332991 PALBOCICLIB - GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The study is a randomized double blind placebo controlled Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant Faslodex over fulvestrant alone in prolonging PFS in women with HR HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy The safety between the two treatment arms will also be compared During study treatment pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin Zoladex or generic
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 |
|---|---|---|---|
| 2013-002580-26 | EUDRACT_NUMBER | None | None |