Study of Combined Fulvestrant and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure

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 100,000/ul, Hb >9 gm/dl, international normalized ratio (INR) 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