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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

Phase 2
18 Years
Open (Enrolling)
Breast Neoplasms, mTor Protein

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit at 24 weeks

Outcome Time Frame:

42 months

Safety Issue:


Principal Investigator

Thomas Bachelot, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • mTor Protein
  • Hormonoresistance
  • tamoxifen
  • Previously received anti-aromatase treatment
  • mTor inhibitor
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis