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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
20mg daily (1 cap) until unbearable toxicity or progression
10mg daily (2 caps of 5mg) until unbearable toxicity or progression
Hopital Hotel Dieu
Paris, France
Clinical benefit at 24 weeks
Time frame: 42 months
Partial and complete response per RECIST
Time frame: 42 months
Qualitative and quantitative toxicities
Time frame: 24 months
Overall survival
Time frame: 42 months
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