Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT01773460
Status:
TERMINATED
Last Update Posted:
2016-02-10
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane
Sponsor:
GBG Forschungs GmbH
Organization:
Study Overview
Official Title:
A Multicenter Randomized, Double Blind, Placebo- Controlled, Phase II Study to Compare Endocrine Treatment Alone Versus Endocrine Treatment With Everolimus in Patients With HR+/HER2- Metastatic Breast Cancer and Progression After Previous Treatment With Exemestane and Everolimus
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped terminated early due to low recruitment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Evelyn
Brief Summary:
Everolimus will be given to patients with metastatic breast cancer who already has a progress taking Everolimus but with a change in the endocrine treatment.
Detailed Description:
With continuation of endocrine treatment of breast cancer an adaptive upregulation of different signaling cascades including the PI3K/akt/mTOR pathway results in cell growth stimulation and results in resistance to endocrine therapies. One way to restore endocrine sensitivity is the inhibition of the mTOR pathway in combination with endocrine therapy leading to an increase in PFS compared with endocrine therapy alone. Guidelines recommend the sequential treatment with different endocrine therapies. It therefore appears reasonable to explore if sensitivity can be restored by changing the subsequent endocrine combination partner of Everolimus in case of failure of a combined endocrine-everolimus therapy.
Study Oversight
Has Oversight DMC:
True
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?: