Ignite Creation Date:
2024-05-06 @ 8:13 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02690480
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2016-01-05
Brief Title:
Fulvestrant FPlacebo vs FPalbociclib First Line for Postmenopausal Hormone Receptor Advanced Breast Cancer
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase II Study to Compare Fulvestrant F 500mg Plus Placebo vs F 500mg Plus Palbociclib as First Line Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer Sensitive to Endocrine Therapy GEICAM2014-12
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
FLIPPER
Brief Summary:
This is an international multicentre double-blind controlled randomized phase II study comparing the efficacy and safety of fulvestrant in combination with palbociclib versus fulvestrant plus placebo in postmenopausal women with HR-positiveHER2-negative metastatic breast cancer who have received 5 years of endocrine therapy in the adjuvant setting as treatment for early disease and remained disease free for 12 months following its completion or have de novo metastatic disease
Detailed Description:
Patients must have at least one lesion measurable andor non-measurable that can be accurately assessed at baseline and is suitable for repeated assessment by CT MRI or plan x-ray Patients with bone-only disease must have a lytic or mixed lytic blastic lesion which has not been previously irradiated and can be accurately assessed by CTMRI or x-ray Approximately 190 patients will be randomized 11 between the experimental arm approximately 95 patients treated with fulvestrant plus palbociclib and the control arm approximately 95 patients treated with fulvestrant plus placebo
Primary Objective
To compare the efficacy of fulvestrant in combination with palbociclib versus fulvestrant plus placebo in terms of the rate of Progression-Free Survival PFS at 1 year in postmenopausal women with HR-positiveHER2-negative metastatic breast cancer previously treated with endocrine therapy for at least 5 years and remaining disease free for more than 12 months following its completion or have de novo metastatic disease
Primary Objective
To compare the efficacy of fulvestrant in combination with palbociclib versus fulvestrant plus placebo in terms of the rate of Progression-Free Survival PFS at 1 year in postmenopausal women with HR-positiveHER2-negative metastatic breast cancer previously treated with endocrine therapy for at least 5 years and remaining disease free for more than 12 months following its completion or have de novo metastatic disease
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 |
|---|---|---|---|
| 2015-002437-21 | EUDRACT_NUMBER | None | None |