NCT01298713

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

Phase 2 Study Assessing the Tolerance and Efficacy of Tamoxifen Alone Versus the Association Tamoxifen-RAD001 (Everolimus) in Patients With Anti-aromatase Resistant Breast Metastatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms
• mTor Protein

Interventions

Type	Name	Description
DRUG	Tamoxifen	20mg daily (1 cap) until unbearable toxicity or progression
DRUG	Everolimus	10mg daily (2 caps of 5mg) until unbearable toxicity or progression

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-06-01
• Completion: 2018-09-12
• First posted: 2011-02-18
• Last updated: 2023-09-06

Locations

1 site across 1 country: France