Clinical trial NCT00570921 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: everolimus, fulvestrant
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Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal status, defined as any one of the following criteria: Documented
             history of bilateral oophorectomy, Age 60 years or more, OR Age 45 to 59 and
             satisfying one or more of the following criteria: Amenorrhea for at least 12 months
             and intact uterus OR Amenorrhea for less than 12 months and a follicle stimulating
             hormone (FSH) concentration - within postmenopausal range including: Patients who have
             had a hysterectomy or Patients who have received hormone replacement

          -  Patients must have histologically confirmed invasive breast cancer

          -  Metastatic or locally advanced disease

          -  Patients must have estrogen receptor and/or progesterone receptor positive disease

          -  Measurable or evaluable disease

          -  Failure of aromatase inhibitor therapy within the previous 6 months. Patients who
             received prior tamoxifen are eligible to enroll

          -  Prior aromatase inhibitor therapy or other endocrine therapy must be discontinued at
             least 1 week prior to enrollment and any toxicity from such therapy must have reverted
             to grade I or less at the time of enrollment

          -  Patients must not have received chemotherapy, radiation therapy, or had surgery within
             4 weeks prior to enrollment and any toxicity from such therapy must have recovered to
             grade 1 or less prior to enrollment

          -  Patients must not have received either of the study medications previously

          -  WHO performance status of 0, 1, or 2

          -  Adequate organ function defined as follows: Adequate renal function, defined by a
             serum creatinine within the upper limits of normal, Adequate liver function, defined
             by a bilirubin of < 1.5 the upper limit of normal (ULN) and aspartate aminotransferase
             (AST), alanine aminotransferase (ALT) of ≤ 2.5 times the ULN, Adequate bone marrow
             function, defined as an absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count
             (PLT) >100,000/ul, Hb >9 gm/dl, international normalized ratio (INR) <1.3, and because
             fulvestrant is administered intramuscularly, it should not be used in patients with
             bleeding diatheses, thrombocytopenia or in patients on anticoagulants

          -  Patients will be asked to provide a tumor paraffin block if available

          -  Ability to understand and sign a written informed consent for participation in the
             trial

        Exclusion Criteria:

          -  Known severe hypersensitivity to everolimus (or similar drugs) or any of the
             excipients of this product

          -  Premenopausal status

          -  Other coexisting malignancies with the exception of basal cell carcinoma or cervical
             cancer in situ

          -  Patients with brain metastasis or leptomeningeal involvement

          -  Patients with malignant pleural effusion or ascites only disease

          -  Rapidly progressive visceral disease

          -  WHO performance status of 3 or 4

          -  As judged by the investigator, uncontrolled intercurrent illness including, but not
             limited to: Ongoing or active infection, Symptomatic congestive heart failure,
             Unstable angina pectoris or significant cardiac arrhythmia, Psychiatric illness/social
             situations that would limit compliance with study requirements, Severely impaired lung
             function such as severe chronic obstructive pulmonary disease (COPD) or interstitial
             lung disease, a known forced expiratory volume at one second (FEV1) of < 1.5 liters,
             or dyspnea of grade III or greater, Uncontrolled diabetes as defined by a fasting
             blood sugar (FBS) of > 1.5 ULM, Known liver disease such as cirrhosis or chronic
             hepatitis, Known HIV positivity, OR known condition causing malabsorption

          -  Chronic treatment with systemic steroids or other immunosuppressive agents

          -  Patients should not receive immunization with attenuated live vaccines within one week
             of study entry or during study period

          -  Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the subject to participate in the clinical trial

          -  Prior treatment with an mTOR inhibitor

          -  Treatment with a non-approved or investigational drug within 30 days or 5 half-lives
             of the drug, whichever is greater, before Day 1 of study treatment

          -  In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that
             would preclude intramuscular injections

          -  History of hypersensitivity to castor oil