NCT01773460

Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus is given beyond progress (comparison with placebo)
DRUG	Everolimus-placebo	Everolimus-placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-01-23
• Last updated: 2016-02-10

Locations

1 site across 1 country: Germany