Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02404051
Status:
UNKNOWN
Last Update Posted:
2016-06-15
First Post:
2015-01-26
Brief Title:
Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
Sponsor:
Consorzio Oncotech
Organization:
Consorzio Oncotech
Study Overview
Official Title:
Fulvestrant Followed by Everolimus Plus Exemestane vs Examestane and Everolimus Followed by Fulvestrant in Postmenopausal Women With HR and HER2- Locally Advanced LABC or Metastatic Breast Cancer MBC Previously Treated With NSAI
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
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:
FEVEX
Brief Summary:
This is a multi-center randomized open-label parallel group study designed to evaluate efficacy and safety of fulvestrant followed at progression by examestane and everolimus versus examestane and everolimus followed at progression by fulvestrant in postmenopausal women with HR and HER2- LABC or MBC whose disease has progressed to NSAI in the adjuvant or metastatic setting
Detailed Description:
In this study everolimus will be administered in combination with exemestane which is an irreversible steroidal aromatase inactivator that has demonstrated efficacy in the treatment of postmenopausal patients with ABC Exemestane is indicated for adjuvant treatment of postmenopausal women with HR EBC who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy It is also indicated for the treatment of ABC in postmenopausal women whose disease has progressed following tamoxifen therapy in the USA or following antiestrogen therapy in Europe In 2011 the BOLERO-2 trial reported 5 33 a significant benefit for HR HER2- postmenopausal pretreated women in the ABC setting by combining everolimus with exemestane In this randomized double-blind placebo-controlled trial a statistically significant improvement in PFS by adding everolimus to exemestane versus exemestane alone was reported Adding everolimus determined a 24-fold prolongation in PFS from 32 up to 74 months and so lowered the risk of cancer progression by 56 for these women These findings were confirmed by an independent assessment 41 vs 110 months risk reduction 64 The QoL data shows positive trend in the everolimus plus exemestane treatment arm
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 |
|---|---|---|---|
| 2014-004035-38 | EUDRACT_NUMBER | None | None |