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

ARCAGY/ GINECO GROUP

Status and phase

Completed

Phase 2

Conditions

mTor Protein

Breast Neoplasms

Treatments

Drug: Everolimus

Drug: Tamoxifen

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01298713

TAMRAD

EUDRACT 2006-004332-79

Details and patient eligibility

About

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.

Enrollment

111 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Menopausal female patient aged > 18 years
Histologically proven breast adenocarcinoma
ER and/or PR positive receptors and HER2 negative
previously received first or second line of hormonotherapy for metastatic disease
previously treated with anti-aromatase in adjuvant and/or in metastatic line
presence of one or several mesurable or evaluable metastatic lesion(s)
presence of at least one target lesion not previously irradiated
ECOG Performance status < 2
adequate biological values
patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion criteria

patient with only local metastatic disease that can be treted by surgery
uncotrolled brain metastases, pulmonary carcinomatosal lymphangitis, hepatic metastases
Previous treatment by Tamoxifen unless in adjuvant and terminated more than a year before metastatic relapse
Patient with a tumor surexpressing HER2 that should be treated by trastuzumab
Patient that need an immediate local antalgic radiotherapy
Thrombo-embolism disease
serious concomitant pathology or uncontrolled that is susceptible to compromise the participation in the study
history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin) and cancers cured for at least for 5 years
patient with an history of significant cardiovascular impairment (congestive heart failure> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
patient with a known allergy to one or several of the study compounds
patients who may not be regularly available due to geographical, social or family reasons
history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
deficiencies of the upper intestinal tract, malabsorption syndrome
patient who is pregnant, breast-feeding or using inadequate contraception
Treatment with experimental drugs (mTor inhibitor or tyrosin kinase inhibitor)
Patient treated with molecules that interfer with isoenzyme CYP3A