Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Everolimus; Exemestane; Everolimus Placebo
Intervention description: Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.; Exemestane 25 mg orally daily.; Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
Intervention MeSH terms: Everolimus; Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 724.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Estrogen Receptor positive; ER+; exemestane; mTOR; everolimus; refractory; NSAI

Summary:

      There are no treatments specifically approved after recurrence or progression on a non
      steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for
      postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study
      is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane +
      placebo in postmenopausal women with estrogen receptor positive locally advanced or
      metastatic breast cancer refractory to NSAI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not
             amenable to curative treatment by surgery or radiotherapy.

          -  Histological or cytological confirmation of estrogen-receptor positive (ER+) breast
             cancer

          -  Postmenopausal women.

          -  Disease refractory to non steroidal aromatase inhibitors (NSAI),

          -  Radiological or clinical evidence of recurrence or progression on or after the last
             systemic therapy prior to randomization.

          -  Patients must have at least one lesion that can be accurately measured or bone lesions
             in the absence of measurable disease as defined above.

        Exclusion Criteria:

          -  HER2-overexpressing patients

          -  Patients with only non-measurable lesions other than bone metastasis (e.g. pleural
             effusion, ascites etc.).

          -  Patients who received more than one chemotherapy line for Advanced Breast Cancer.

          -  Previous treatment with exemestane or mTOR inhibitors.

          -  Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).

          -  Radiotherapy within four weeks prior to randomization

          -  Currently receiving hormone replacement therapy,

        Other protocol-defined inclusion/exclusion criteria may apply