drugset / Trial / NCT01298713

Tamoxifen-RAD001 Versus Tamoxifen Alone in Patients With Anti-aromatase Resistant Breast Metastatic Cancer

NCT01298713

Phase 2 Completed 111 enrolled ARCAGY/ GINECO GROUP Novartis · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases. The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This study is aimed to check if the inhibition of this signal transduction pathway by a synthetic mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.

Timeline

Start
2008-03
Primary completion
2011-06
Completion
2018-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 10 mg
Subject Tamoxifen Small molecule 20 mg